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PA/PH/SG (16) 7 FINAL SHORT 1
1
TERMS OF REFERENCE AND PROFILE FOR MEMBERS OF2GROUPS OF EXPERTS AND WORKING PARTIES3
4
CANDIDATES FROM A NON-EUROPEAN PHARMACOPOEIA MEMBER STATE 56
The terms of reference and profiles shown below have been approved by the Ph. Eur. Commission at its 154th7session (March 2016). Experts shall fulfil the profile described. It is also expected that experts once appointed 8by the Ph. Eur. Commission will be available to attend meetings and are prepared to draft and/or verify 9monographs and general chapters and when required in the profile, have access to a laboratory for 10experimental verifications. 11
12Each group of expert and working party will advise the Commission according to their expertise and contribute 13to the maintenance of the relevant technical guide where appropriate. 14
15
Group of Experts No. 1 (Microbiology)............................................................................................................. 416
Group of Experts No. 6 (Biological and Biotechnological products)................................................................... 417
Group of Experts No. 6B (Human Plasma and Plasma Products)........................................................................ 418
Group of Experts No. 7 (Antibiotics)................................................................................................................. 519
Group of experts No. 9 (Inorganic Chemistry) ................................................................................................... 520
Group of Experts No. 9G (Medicinal Gases)...................................................................................................... 621
Group of Experts No. 10A/B/C/D (Organic chemistry – synthetic and semi-synthetic products) ......................... 622
Group of Experts No. 11 (Organic chemistry – natural, semi-synthetic and synthetic products) .......................... 623
Group of Experts No. 12 (Dosage forms and dosage form methods)................................................................... 724
Group of Experts No. 13A/B (Herbal Drugs and Herbal Drug Products) ............................................................ 725
Group of Experts No. 13H (Fatty oils and derivatives, polymers)....................................................................... 826
Group of Experts No. 14 (Radiopharmaceutical Preparations)............................................................................ 827
Group of Experts No. 15 (Human Vaccines and Sera)........................................................................................ 928
Group of Experts No. 15V (Veterinary Vaccines and Sera)................................................................................ 929
Group of Experts No. 16 (Plastic materials, plastic containers and closures)....................................................... 930
BET Working Party (Bacterial Endotoxin Test)............................................................................................... 1031
CE Working Party (Capillary Electrophoresis) ................................................................................................ 1032
CEL Working Party (Cellulose) ...................................................................................................................... 1033
CLAR Working Party (Clarity and degree of opalescence of liquids) ............................................................... 1134
CND Working Party (Conductivity) ................................................................................................................ 1135
COL Working Party (Colour determination).................................................................................................... 1136
CRB Working Party (Carbohydrates) .............................................................................................................. 1237
CST Working Party (Chromatographic separation techniques)......................................................................... 1238
CTP Working Party (Cell Therapy Products) ................................................................................................... 1239
DIA Working party (Dialysis) ......................................................................................................................... 1340
EXT Working Party (Extracts) ........................................................................................................................ 1341
FRC Working Party (Functionality-related Characteristics).............................................................................. 1442
GEL Working Party (Gelatin) ......................................................................................................................... 1443
GLS Working Party (Glass Containers) ........................................................................................................... 1444
HM Working Party (Heavy metals) ................................................................................................................. 1545
2 PA/PH/SG (16) 7 FINAL SHORT
HMM Working Party (Homoeopathic Manufacturing Methods) ...................................................................... 151
HOM Working Party (Homoeopathic Raw Materials and Stocks) .................................................................... 152
ICP Working Party (Inductively-Coupled Plasma ).......................................................................................... 163
INH Working Party (Inhalations) .................................................................................................................... 164
LBP Working Party (Live Biotherapeutic Products)......................................................................................... 165
LEC Working Party (Lecithins)....................................................................................................................... 176
MAB Working Party (Monoclonal Antibodies) ............................................................................................... 177
MG Working Party (General methods) ............................................................................................................ 178
NBC Working Party (Non-Biological Complexes)........................................................................................... 189
PAT Working Party (Process Analytical Technology) ..................................................................................... 1810
POW Working Party (Powders) ...................................................................................................................... 1911
PRP Working Party (Precursors for Radiopharmaceutical Preparations)........................................................... 1912
PST Working Party (Pesticide Residues) ......................................................................................................... 1913
SIT Working Party (Second identification test)................................................................................................ 2014
SRP Working Party (Special Revision Programme)......................................................................................... 2015
ST Working Party (Standard Terms) ............................................................................................................... 2016
STA Working Party (Statistics) ....................................................................................................................... 2117
SUT Working Party (Sutures) ......................................................................................................................... 2118
TCM Working Party (Traditional Chinese Medicines) ..................................................................................... 2119
VIT Working Party (Vitamins)........................................................................................................................ 2220
VSADM Working party (Vibrational Spectroscopy and Analytical Data Modelling)........................................ 2221
WAT Working Party (Water) .......................................................................................................................... 2222
2324
PA/PH/SG (16) 7 FINAL SHORT 1
Group of Experts No. 1 (Microbiology)1
Terms of reference2
Drafting and revision of general chapters allocated to the group by the Commission in the field of 3microbiology4
Advising the Commission on questions related to microbiological quality, including quality attributes in 5monographs drafted by other groups of experts and working parties6
International harmonisation of general chapters in the field of microbiology where decided by the 7
Commission8
Drafting and revision of general chapters allocated to the group by the Commission in the field of 9alternative microbiological methods (the so called “rapid” methods)10
Profile for experts11
Current expertise in microbiological analytical methods, related to quality control of active substances, 12excipients and medicinal products and in development of control methods13
Several years of experience in one or more of the following fields14
o Microbiological quality control in a pharmaceutical manufacturing setting, in a hospital 15environment or in an independent testing laboratory16
o Market surveillance of microbiological quality in a regulatory authority17
o Assessment of the relevant parts of applications for marketing authorisation18
o Development of microbiological control methods in a research and development environment19
Group of Experts No. 6 (Biological and Biotechnological products)20
Terms of reference21
Drafting and revision of monographs and general chapters allocated to the group by the Commission in 22the field of biological products, biotechnological products, synthetic peptides including glycan mapping 23
International harmonisation of general chapters in the field of biological products where decided by the 24Commission25
Profile for experts26
Current expertise in quality control of biological products, biotechnological products, peptides27
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,28Essential: Active involvement in drafting of texts and laboratory verification of test methods29
Several years of experience in one or more of the following fields:30
o Quality control of biological products, biotechnological products, peptides in a pharmaceutical 31manufacturing setting32
o Quality control in a regulatory authority33
o Quality control of biological or biotechnological products in an independent testing laboratory34
o Development of methods for control of biological products, biotechnological products, 35peptides in a research and development environment36
o Method development and verification in a regulatory authority37
o Assessment of the relevant parts of application for marketing authorisation of biological and 38biotechnological products within a medicines agency39
Group of Experts No. 6B (Human Plasma and Plasma Products)40
Terms of reference41
Drafting and revision of general chapters and monographs allocated to the group by the Commission in 42the field of blood products43
Profile for experts44
Current expertise in the field of blood products, notably related to quality control of and development of 45control methods46
2 PA/PH/SG (16) 7 FINAL SHORT
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,1Essential: Active involvement in drafting of texts and laboratory verification of test methods2
Several years of experience in one or more of the following fields:3
o Quality control of blood products in a pharmaceutical or bulk manufacturing setting4
o Batch release or market surveillance of Human Blood, Plasma and Plasma Products in a 5regulatory authority6
o Assessment of the relevant parts of applications for marketing authorisation within a medicines 7agency8
o Quality control of blood products in an independent testing laboratory9
o Development of methods for control Human Plasma and Plasma Products in a research and 10development environment11
Group of Experts No. 7 (Antibiotics)12
Terms of reference13
Drafting and revision of monographs and general chapters allocated to the group by the Commission in 14the field of antibiotics (active substances and/or finished products if / when allocated to the group by the 15Commission)16
Profile for experts17
Current expertise in the fields covered by the terms of reference18
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,19Essential: Active involvement in drafting of texts and laboratory verification of test methods20
Several years of experience in one or more of the following fields:21
o Quality control of antibiotics (active substances and/or finished products) in a pharmaceutical 22manufacturing setting23
o Quality control of antibiotics (active substances and/or finished products) in a bulk 24manufacturing setting25
o Quality control of antibiotics (active substances and/or finished products) in a regulatory 26authority27
o Assessment of the relevant parts of applications for marketing authorisation within a medicines 28agency29
o Quality control of antibiotics (active substances and/or finished products) in an independent 30testing laboratory31
o Development of methods for control of antibiotics in a research and development environment32
o Method development and verification in a regulatory authority33
Group of experts No. 9 (Inorganic Chemistry)34
Terms of reference35
Drafting and revision of monographs allocated to the group by the Commission in the field of inorganic 36products37
International harmonisation of monographs where decided by the Commission38
Profile for experts39
Current expertise in pharmaceutical analytical methods, related to quality control of inorganic active 40substances and excipients and in development of control methods41
Access to laboratory facilities for verification of methods proposed for inclusion in monographs, for 42example ICP and/or AAS. Essential: Active involvement in drafting of texts and laboratory verification 43of test methods44
Several years of experience in one or more of the following fields:45
o Quality control inorganic active substances and excipients in a pharmaceutical or bulk 46manufacturing setting47
o Market surveillance of quality in a regulatory authority48
PA/PH/SG (16) 7 FINAL SHORT 1
o Pharmaceutical quality control in an independent testing laboratory1
o Development of methods for control of inorganic products in a research and development 2environment3
o Method development and verification in a national pharmacopoeia laboratory4
Group of Experts No. 9G (Medicinal Gases)5
Terms of reference6
Drafting and revision of monographs and general chapters allocated to the group by the Commission in 7the field of medicinal gases8
Profile for experts9
Current expertise in the fields covered by the terms of reference10
Access to laboratory facilities for verification of methods proposed for inclusion in monographs, 11Essential: Active involvement in drafting of texts and laboratory verification of test methods12
Several years of experience in one or more of the following fields:13
o Quality control of medicinal gases in a pharmaceutical manufacturing, hospital or industrial 14setting15
o Quality control in a regulatory authority16
o Development of methods for control of medicinal gases in a research and development 17environment18
Group of Experts No. 10A/B/C/D (Organic chemistry – synthetic and semi-synthetic products)19
Terms of reference20
Drafting and revision of monographs allocated to the group by the Commission in the field of synthetic 21and semi-synthetic organic active substances and excipients22
Drafting and revision of finished product monographs with chemically defined active substance if / 23when allocated to the group by the Commission 24
Profile for experts25
Current expertise in pharmaceutical analytical methods, related to quality control of active substances, 26excipients and finished products with chemically defined active substance and in development of 27control methods28
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,29Essential: Active involvement in drafting of texts and laboratory verification of test methods30
Several years of experience in one or more of the following fields:31
o Quality control in a pharmaceutical manufacturing setting32
o Quality control of synthetic and semi-synthetic organic products in a bulk manufacturing 33setting34
o Market surveillance of quality in a regulatory authority35
o Pharmaceutical quality control of active substances, excipients and /or finished products with 36chemically defined active substances in an independent testing laboratory37
o Development of methods for control of active substances, excipients and /or finished products38with chemically defined active substances in a research and development environment39
o Group 10D: development of control methods for amino-acids40
o Method development and verification in a regulatory authority41
Group of Experts No. 11 (Organic chemistry – natural, semi-synthetic and synthetic products)42
Terms of reference43
Drafting and revision of monographs allocated to the group by the Commission in the field of natural, 44semi-synthetic and synthetic organic active substances, excipients and finished products if / when 45allocated to the group by the Commission)46
2 PA/PH/SG (16) 7 FINAL SHORT
Profile for experts1
Current expertise in pharmaceutical analytical methods, related to quality control of active substances, 2excipients and finished products and in development of control methods3
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,4Essential: Active involvement in drafting of texts and laboratory verification of test methods5
Several years of experience in one or more of the following fields:6
o Quality control in a pharmaceutical manufacturing setting7
o Quality control of natural, semi-synthetic and synthetic organic products (active substances, 8excipients and/or finished products) in a bulk manufacturing setting9
o Market surveillance of quality in a regulatory authority10
o Pharmaceutical quality control in an independent testing laboratory11
o Development of methods for control of active substances and /or excipients and/or finished 12products in a research and development environment13
o Method development and verification in a regulatory authority14
Group of Experts No. 12 (Dosage forms and dosage form methods)15
Terms of reference16
Drafting and revision of dosage form monographs17
Maintenance of dosage form related International Harmonisation topics such as:18
o uniformity of dosage units19
o dissolution20
o disintegration21
o particulate contamination: sub-visible particles22
Profile for experts23
Current expertise in pharmaceutical development and control methods applied during manufacture and 24to finished pharmaceutical preparations, in the relevant specialities defined in the terms of reference25
Several years of experience in one or more of the following fields:26
o Development and quality control of pharmaceutical preparations in an industrial setting27
o Assessment of the relevant parts of applications for marketing authorisation within a medicines 28agency29
o Development of methods for testing of pharmaceutical preparations in a research and 30development environment31
o Method development and verification in a regulatory authority32
Group of Experts No. 13A/B (Herbal Drugs and Herbal Drug Products)33
Terms of reference34
Drafting and revision of monographs allocated to the group by the Commission in the field of herbal 35drugs and herbal drug preparations36
Profile for experts37
Current expertise in pharmaceutical analytical methods, related to quality control of herbal drugs and 38herbal drug preparations and in development of control methods39
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,40Essential: Active involvement in drafting of texts and laboratory verification of test methods41
Several years of experience in one or more of the following fields:42
o Quality control of herbal drugs and herbal drug preparations in a pharmaceutical 43manufacturing or bulk manufacturing setting44
o Market surveillance of quality of herbals in a regulatory authority45
o Assessment of the relevant parts of applications for marketing authorisation of herbal 46medicinal products within a medicines agency47
PA/PH/SG (16) 7 FINAL SHORT 1
o Pharmaceutical quality control of herbal drugs and herbal drug preparations in an independent 1testing laboratory2
o Development of methods for control of herbal drugs in a research and development 3environment4
o Method development and verification in a regulatory authority5
Group of Experts No. 13H (Fatty oils and derivatives, polymers)6
Terms of reference7
A panel of Specialists is appointed for the drafting and revision of monographs allocated to the group 8by the Commission in the field of:9
o surfactants10
o fatty oils, fats and waxes11
o fatty acids, fatty alcohols and their esters/ethers12
o macrogols, macrogol derivatives and other polymers (i.e. carbomers)13
o Paraffins14
International Harmonisation of the relevant monographs 15
Profile for experts16
Current expertise in pharmaceutical analytical methods, related to quality control in the relevant 17specialities defined in the terms of reference18
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,19Essential: Active involvement in drafting of texts and laboratory verification of test methods20
Several years of experience in one or more of the following fields:21
o Quality control in a pharmaceutical manufacturing setting22
o Quality control of fats etc. in a bulk manufacturing setting23
o Market surveillance of quality in a regulatory authority24
o Pharmaceutical quality control of fats etc. in an independent testing laboratory25
o Development of methods for control of fats etc. in a research and development environment26
o Method development and verification in a regulatory authority27
Group of Experts No. 14 (Radiopharmaceutical Preparations)28
Terms of reference29
Drafting and revision of monographs allocated to the group by the Commission in the field of 30radiopharmaceutical preparations31
Profile for experts32
Current expertise in pharmaceutical analytical methods, related to quality control of 33radiopharmaceutical preparations and in development of control methods34
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,35Essential: Active involvement in drafting of texts and laboratory verification of test methods36
Several years of experience in one or more of the following fields:37
o Quality control of radiopharmaceutical preparations in a pharmaceutical manufacturing setting 38or in a hospital39
o Market surveillance of quality of radiopharmaceutical preparations in a regulatory authority40
o Assessment of the relevant parts of applications for marketing authorisation within a medicines 41agency42
o Pharmaceutical quality control of radiopharmaceutical preparations in an independent testing 43laboratory44
o Method development and verification in a regulatory authority45
2 PA/PH/SG (16) 7 FINAL SHORT
Group of Experts No. 15 (Human Vaccines and Sera)1
Terms of reference2
Drafting and revision of monographs allocated to the group by the Commission in the field of vaccines 3and sera for human use4
Drafting and revision of monographs allocated to the group by the Commission in the field of 5botulinum toxins6
Profile for experts7
Current expertise in analytical methods, related to quality control of vaccines and sera for human use 8and in development of control methods9
Several years of experience in one or more of the following fields:10
o Quality control of vaccines and sera for human use in a pharmaceutical manufacturing setting11
o Batch release and market surveillance of quality of vaccines and sera for human use in a 12regulatory authority13
o Assessment of the relevant parts of applications for marketing authorisation within a medicines 14agency15
o Quality control of vaccines and sera for human use in an independent testing laboratory16
Group of Experts No. 15V (Veterinary Vaccines and Sera)17
Terms of reference18
Drafting and revision of monographs allocated to the group by the Commission in the field of 19immunological veterinary medicinal products (IVMP)20
Profile for experts21
Current expertise in suitable standards for IVMP, in methods related to quality control of these products 22and in development of control methods23
Several years of experience in one or more of the following fields:24
o Quality control of IVMP in a regulatory authority25
o Assessment of the relevant parts of applications for marketing authorisation within a medicines 26agency27
o Batch release and market surveillance of quality in a regulatory authority28
o Development of methods for control of IVMP in a research and development environment29
Industry representatives are normally not appointed to Group of Experts No. 15V. They may be invited 30to contribute to elaboration of texts during hearings organised on a case-by-case basis by the 31Secretariat.32
33Group of Experts No. 16 (Plastic materials, plastic containers and closures)34
Terms of reference35
Drafting and revision of general chapters allocated to the working party by the Commission in the field 36of plastic materials, plastic containers and closures37
Profile for experts38
Current expertise in the fields covered by the terms of reference39 Access to laboratory facilities for verification of methods proposed for inclusion in general chapters,40
Essential: Active involvement in drafting of texts and laboratory verification of test methods41 Several years of experience in one or more of the following fields:42
o Quality control of plastic materials, plastic containers and closures in a pharmaceutical 43manufacturing setting44
o Quality control of plastic materials, plastic containers and closures in a regulatory authority45o Assessment of the relevant parts of applications for marketing authorisation within a medicines 46
agency47
PA/PH/SG (16) 7 FINAL SHORT 1
o Quality control of plastic materials, plastic containers and closures in an independent testing 1laboratory 2
o Method development and verification in a regulatory authority3
BET Working Party (Bacterial Endotoxin Test)4
Terms of reference5
International Harmonisation of monographs and general chapters as decided by the Commission6
Drafting and revision of general chapters allocated to the group by the Commission in the field of 7bacterial endotoxins8
Advising the Commission on acceptance criteria for bacterial endotoxins to be included in monographs, 9in accordance with the European Pharmacopoeia policy on bacterial endotoxins in substances for 10pharmaceutical use, Approved by the European Pharmacopoeia Commission at its 149th Session, 11June 201412(http://pharmeuropa.edqm.eu/home/menupage/English/Useful%20Information/Ph_Eur_policy_for_Phar13meuropa_E.pdf)14
Drafting and revision of general chapters allocated to the group by the Commission in the field of the 15monocyte activation tests (MAT)16
Profile for experts 17
Several years of experience in one or more of the following fields:18
o Quality control of parenteral preparations, active substances and/or excipients in a 19pharmaceutical manufacturing setting20
o Market surveillance of quality in a regulatory authority21
o Pharmaceutical quality control in an independent testing laboratory22
o Development of control methods for bacterial endotoxin test in a research and development 23environment24
25
CE Working Party (Capillary Electrophoresis)26
Terms of reference27
Revision of the chapter 2.2.47 Capillary electrophoresis as decided by the Commission 28
Advising the Commission on questions related to capillary electrophoresis in monographs drafted by 29other groups of experts and working parties30
Profile for experts31
Current expertise in Capillary electrophoresis techniques32
Several years of experience in the following fields:33
o Quality control of active substances, excipients and medicinal products, using capillary 34electrophoresis techniques, in a pharmaceutical manufacturing setting, in a regulatory authority 35or in any other testing laboratory36
o Development of capillary electrophoresis methods for control of active substances, excipients 37and medicinal products in a research and development environment or at university38
o Essential: Active involvement in drafting of texts and laboratory verification of test methods39
CEL Working Party (Cellulose)40
Terms of reference41
Drafting and revision of monographs allocated to the group by the Commission on cellulose and 42cellulose derivatives43
International harmonisation of monographs on cellulose and cellulose derivatives as decided by the 44Commission45
2 PA/PH/SG (16) 7 FINAL SHORT
Profile for experts 1
Current expertise in analytical methods for cellulose and cellulose derivatives and in development of 2control methods3
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,4Essential: Active involvement in drafting of texts and laboratory verification of test methods5
Several years of experience in one or more of the following fields:6
o Quality control of cellulose and cellulose derivatives in a pharmaceutical or other industrial 7manufacturing setting8
o Market surveillance of quality of cellulose and cellulose derivatives in a regulatory authority9
o Quality control of cellulose and cellulose derivatives in a regulatory authority10
o Development of control methods for cellulose and cellulose derivatives in a research and 11development environment12
o Method development and verification in a regulatory authority13
CLAR Working Party (Clarity and degree of opalescence of liquids)14
Terms of reference 15
To evaluate the request for revision related to chapter 2.2.1 Clarity and degree of opalescence of liquids and to 16revise, if applicable, the corresponding chapter.17
Profile for experts 18
Current expertise in pharmaceutical analytical methods, related to the control of Clarity and degree of 19opalescence of liquids in development of control methods20
Several years of experience in one or more of the following fields:21
o Quality control applying one or more methods as described in chapter 2.2.122
o Market surveillance of quality in a regulatory authority23
CND Working Party (Conductivity)24
Terms of reference25
International harmonisation of general chapter 2.2.38 Conductivity26
Profile for experts 27
Current expertise in conductivity measurement28
Several years of experience in one or more of the following fields:29
o Quality control using conductivity measurement in a pharmaceutical manufacturing setting30
o Market surveillance of quality using conductivity measurement in a regulatory authority31
o Conductivity measurement for pharmaceutical analysis in an independent testing laboratory32
o Conductivity measurement in a regulatory authority33
o Development of methods for conductivity measurement in a research and development 34environment35
COL Working Party (Colour determination)36
Terms of reference 37
Drafting and revision of monographs and texts allocated to the Working Party by the Commission in the 38field of instrumental determination of colour (PDG item Q-07) 39
Establishing correlation between measurement using Ph. Eur. Chapter 2.2.2 and the tristimulus type 40instruments41
Profile for experts 42
Several years of experience in one or more of the following fields:43
PA/PH/SG (16) 7 FINAL SHORT 1
o Users: Expertise in the use of tristimulus-type of colour measuring instruments in the field of 1pharmaceutical development, quality control of pharmaceuticals, food, cosmetics or drinking 2water3
o Instrument suppliers: Personnel involved in user-support for practical application of 4tristimulus-type instruments in the field of pharmaceutical development , quality control of 5pharmaceuticals, food, cosmetics or drinking water6
o Experience in research or university teaching related to instrumental colour determination of 7liquids8
CRB Working Party (Carbohydrates)9
Terms of reference10
Drafting and revision of monographs allocated to the group by the Commission in the field of 11carbohydrates12
International harmonisation of monographs13
Profile for experts 14
Current expertise in pharmaceutical analytical methods, related to quality control of carbohydrates and 15in development of control methods16
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,17Essential: Active involvement in drafting of texts and laboratory verification of test methods18
Several years of experience in one or more of the following fields:19
o Quality control in a pharmaceutical or bulk manufacturing setting20
o Market surveillance of quality in a regulatory authority21
o Pharmaceutical quality control in an independent testing laboratory22
o Development of control methods for carbohydrates in a research and development 23environment24
o Method development and verification in a regulatory authority25
CST Working Party (Chromatographic separation techniques)26
Terms of reference27
Revision of the chapter 2.2.46 Chromatographic separation techniques as decided by the Commission28
Revision of other chapters on chromatographic separation (e.g. 2.2.29, 2.2.30) as decided by the 29Commission30
International harmonisation of chapter 2.2.46 (PDG item G-20)31
Profile for experts 32
Current expertise in chromatographic separation techniques33
Several years of experience in one or more of the following fields:34
o Chromatographic quality control of active substances and/or excipients in a pharmaceutical 35manufacturing setting36
o Development of chromatographic methods for control of active substances, excipients and 37medicinal products in a research and development environment38
o Market surveillance of quality in a regulatory authority39
o Pharmaceutical quality control in an independent testing laboratory40
CTP Working Party (Cell Therapy Products)41
Terms of reference42
Revision of general chapter 2.6.27 Microbiological control of cellular products allocated to the group 43by the Commission44
Elaboration of a general text dealing with microbiological control of organs and tissues for human use, 45including preservation and other related media (e.g. sampling, deswelling media)46
2 PA/PH/SG (16) 7 FINAL SHORT
Profile for experts 1
Current expertise in analytical methods, related to development and quality control of cell therapy 2
products and/or tissue-engineered products and/or to quality control of organs and tissues for human 3
use, and in development of microbiological control methods4
Several years of experience in one or more of the following fields:5
o Development of cell therapy products and/or tissue-engineered products6
o Microbiological quality control of cell therapy products and/or tissue-engineered products in a 7pharmaceutical manufacturing setting or in a hospital environment and/or microbiological 8control of tissues and organs used for human transplantation9
o Assessment of applications for marketing authorisation of cell therapy and/or tissue-10engineered products11
o Market surveillance of microbiological quality of cell therapy products, tissue-engineered 12products and/or tissues and organs used for human transplantation in a regulatory authority13
o Microbiological quality control of cell therapy products, tissue-engineered products and/or 14tissues and organs used for human transplantation in an independent testing laboratory15
o Development of methods for microbiological control of cell therapy products, tissue-16engineered products and/or tissues and organs used for human transplantation in a research and 17development environment18
DIA Working party (Dialysis)19
Terms of reference20
Drafting and revision of monographs and general chapters allocated to the working party by the 21Commission in the field of preparations for dialysis22
Profile for experts 23
Current expertise in the fields covered by the terms of reference24
Access to laboratory facilities for verification of methods proposed for inclusion in monographs25
Several years of experience in one or more of the following fields:26
o Quality control of preparations for dialysis in a pharmaceutical manufacturing setting or in a 27hospital28
o Quality control of preparations for dialysis in a regulatory authority29
o Assessment of the relevant parts of applications for marketing authorisation within a medicines 30agency31
o Quality control of preparations for dialysis in an independent testing laboratory32
o Method development and verification in a regulatory authority33
EXT Working Party (Extracts)34
Terms of reference35
Revision of the general monograph on Extracts (0765) with the aim of clarifying/improving the 36definitions and requirements of the different types of extracts whilst maintaining the established 37classification system of extracts38
Profile for experts 39
Several years of experience in one or more of the following fields:40
o Assessment of the relevant parts of applications for marketing authorisation of herbal 41medicinal products within a medicines agency42
o Production or quality control of extracts for further use in herbal medicinal products43
o Production or quality control of herbal medicinal products containing extracts44
PA/PH/SG (16) 7 FINAL SHORT 1
FRC Working Party (Functionality-related Characteristics)1
Terms of reference2
Drafting and revision of FRC sections of monographs on excipients, in consultation with the 3appropriate Groups of Experts of the Ph. Eur.4
Maintenance of general chapter 5.15 FRCs of excipients5
Profile for experts 6
Current expertise in analytical methods, related to control of excipients and in development of control 7methods8
Several years of experience in one or more of the following fields:9
o Quality control of excipients in a pharmaceutical manufacturing setting10
o Quality control of excipients in a bulk manufacturing setting11
o Formulation of medicinal products (pharmaceutical development)12
o Assessment of the relevant parts of applications for marketing authorisation within a medicines 13agency14
o Development of control methods for determination of FRCs in a research and development 15environment16
o Pharmaceutical quality control in an independent testing laboratory17
GEL Working Party (Gelatin)18
Terms of reference19
To provide support and advice in case of questions raised by e.g. users in the field of gelatin20
International harmonisation of monographs on Gelatin21
Profile for experts:22
Current expertise in pharmaceutical analytical methods, related to quality control of gelatin and in 23development of control methods24
Several years of experience in one or more of the following fields:25
o Quality control in a pharmaceutical or bulk manufacturing setting (gelatin or use of gelatin)26
o Market surveillance of quality in a regulatory authority27
o Pharmaceutical quality control in an independent testing laboratory28
o Method development and verification in a regulatory authority29
o Development of pharmaceutical control methods using near infrared spectrometry for gelatin 30identification31
GLS Working Party (Glass Containers)32
Terms of reference33
Drafting and revision of general chapters allocated to the group by the Commission in the field of glass 34containers35
Profile for experts 36
Current expertise in the production of glass containers, analytical methods, related to quality control of 37glass containers and in development of control methods38
Access to laboratory facilities for verification of methods proposed for inclusion in monographs39
Several years of experience in one or more of the following fields:40
o Quality control in a pharmaceutical manufacturing setting for control of glass containers41
o Production and/or Quality control of glass containers in an industrial setting42
o Market surveillance of quality in a regulatory authority43
o Pharmaceutical quality control in an independent testing laboratory44
o Development of control methods for control of glass containers in a research and development 45environment46
2 PA/PH/SG (16) 7 FINAL SHORT
HM Working Party (Heavy metals)1
Terms of reference2
Drafting of a general chapter to implement the future ICH Q3D guideline on metal impurities. In this 3context, identification of technical issues which need to be addressed by ICP working party such as 4sample preparation and instrumental determination by atomic emission spectrometry, inductively 5coupled plasma - atomic emission spectrometry and inductively coupled plasma - mass spectrometry6and which would require an update of the respective general methods7
International harmonisation of chapter 2.4.20 (PDG item G-07)8
Profile for experts 9
Up-to-date substantial expertise in pharmaceutical analytical methods, related to quality control of 10active substances and excipients allowing a holistic view on the occurrence of metals from either 11synthesis or contamination12
Several years of experience in one or more of the following fields:13
o Quality control in a pharmaceutical manufacturing setting14
o Quality control of synthetic and semi-synthetic organic products in a bulk manufacturing 15setting16
o Assessment of the relevant parts of applications for marketing authorisation within a medicines 17agency18
o Pharmaceutical quality control of active substances and /or excipients in an independent 19testing laboratory specialised in testing for metals as residues from synthesis or contaminants20
HMM Working Party (Homoeopathic Manufacturing Methods)21
Terms of reference22
Drafting and revision of monographs allocated to the group by the Commission in the field of 23homoeopathic manufacturing methods24
Profile for experts 25
Knowledge of currently used homoeopathic manufacturing methods26
Several years of experience in one or more of the following fields:27
o Assessment of application for marketing authorisation of homoeopathic products within a 28medicines agency or equivalent29
Industry representatives are normally not appointed to the HMM Working Party. They may be invited 30to contribute to elaboration of monographs during hearings organised on a case-by-case basis by the 31Secretariat32
HOM Working Party (Homoeopathic Raw Materials and Stocks)33
Terms of reference34
Drafting and revision of monographs allocated to the group by the Commission in the field of 35homoeopathic raw materials and stocks36
Profile for experts 37
Current expertise in pharmaceutical analytical methods, related to quality control of homoeopathic raw 38materials and stocks and in development of control methods39
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,40Essential: Active involvement in drafting of texts and laboratory validation and verification of test 41methods42
Several years of experience in one or more of the following fields:43
o Quality control of homoeopathic raw materials and stocks in a pharmaceutical manufacturing 44setting45
o Assessment of applications for marketing authorisation of homoeopathic products within an 46agency47
o Quality control of homoeopathic raw materials and stocks in an independent testing laboratory48
PA/PH/SG (16) 7 FINAL SHORT 1
o Development of methods for control of homoeopathic raw materials and stocks in a research 1and development environment2
o Method development and verification in a regulatory authority3
ICP Working Party (Inductively-Coupled Plasma )4
Terms of reference5
Drafting and revision of general methods allocated to the working party by the European 6Pharmacopoeia Commission in the field of atomic absorption spectrometry, atomic emission 7spectrometry, inductively coupled plasma - atomic emission spectrometry and inductively coupled 8plasma - mass spectrometry9
Profile for experts 10
Current expertise in the development and application of analytical procedures involving the above 11mentioned techniques12
Several years of experience in one or more of the following fields: 13
o Quality control of herbal drugs, herbal drug preparations, synthetic, semi-synthetic, natural 14origin, biological or biotechnological products in a pharmaceutical setting15
o Quality control in a regulatory authority or an independent testing laboratory16
INH Working Party (Inhalations)17
Terms of reference18
Drafting and revision of monographs and general chapters allocated to the group by the Commission in 19the field of preparations for inhalation20
International harmonisation of general chapters as decided by the Commission21
Profile for experts 22
Current expertise in pharmaceutical analytical methods, related to quality control of preparations for 23inhalation and in development of control methods24
Several years of experience in one or more of the following fields:25
o Quality control of preparations for inhalation in a pharmaceutical manufacturing setting26
o Market surveillance of quality in a regulatory authority27
o Assessment of applications for marketing authorisation of preparations for inhalation within an 28agency29
o Development of control methods for control of preparations for inhalation in a research and 30development environment31
o Pharmaceutical quality control in an independent testing laboratory32
o Method development and verification in a regulatory authority33
LBP Working Party (Live Biotherapeutic Products)34
Terms of reference35
Elaboration of a monograph on Live Biotherapeutic Products, allocated to the Working Party by the 36Commission. Live Biotherapeutic Products (LBP) to be considered in the scope are biological medicinal 37products that contains live micro-organisms such as bacteria or yeast. A LBP may be administered orally, 38vaginally or intravesically. 39
Profile for experts 40
Current expertise in the development, production and/or quality control of Live Biotherapeutic Products41
Several years of experience in one or more of the following fields:42
o development of Live Biotherapeutic Products43
o production of Live Biotherapeutic Products44
o assessment of applications for licensing of Live Biotherapeutic Products45
o micro-organism strain selection and batch production46
o microbiological techniques, molecular techniques applied to microbiology47
2 PA/PH/SG (16) 7 FINAL SHORT
LEC Working Party (Lecithins)1
Terms of reference2
Drafting and revision of monographs allocated to the group by the Commission in the field of lecithins3
Profile for experts4
Current expertise in pharmaceutical analytical methods, related to quality control of lecithins and in 5development of control methods6
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,7Essential: Active involvement in drafting of texts and laboratory verification of test methods8
Several years of experience in one or more of the following fields:9
o Quality control of lecithins in a pharmaceutical or bulk manufacturing setting10
o Market surveillance of quality in a regulatory authority11
o Pharmaceutical quality control in an independent testing laboratory12
o Development of control methods for lecithins in a research and development environment13
o Method development and verification in a regulatory authority14
MAB Working Party (Monoclonal Antibodies)15
Terms of reference:16
To undertake a pilot phase to elaborate general methods for analysis of monoclonal antibodies and 17product specific monographs using the multisource approach 18
Drafting and revision of monographs and general chapters allocated to the group by the Commission in 19the field of monoclonal antibodies 20
Support to the Secretariat in case of questions raised by e.g. users in the field of monoclonal antibodies21
Profile for experts 22
Current expertise in pharmaceutical analytical methods, related to quality control of monoclonal 23antibodies and in development of control methods24
Access to laboratory facilities for verification of methods proposed for inclusion in monographs or 25access to licensing files. Essential: Active involvement in drafting of texts and laboratory verification 26of test methods27
Several years of experience in one or more of the following fields:28
o Quality control of monoclonal antibodies in a pharmaceutical manufacturing setting29
o Market surveillance of quality in a regulatory authority30
o Assessment of applications for marketing authorisation of monoclonal antibodies within an 31agency32
o Development of control methods for control of monoclonal antibodies in a research and 33development environment34
o Pharmaceutical quality control in an independent testing laboratory35
MG Working Party (General methods) 36
Terms of reference37
In reference to the concept paper prepared by the Secretariat and presented to the Ph. Eur. Commission at its 38149th session:39
Make concrete proposals to the Commission, on the best approaches to tackle the revision needs of 40general methods41
Reflect on the content and the degree of details to be provided in general methods in view of drafting a 42guide for the elaboration of general methods at a later stage43
44
PA/PH/SG (16) 7 FINAL SHORT 1
Profile for experts 1
Members of OMCLs, national pharmacopoeia authorities, licensing authorities, universities or the 2pharmaceutical/chemical industries3
Current expertise and extensive knowledge in compendial methods and/or instruments used in the 4quality control of active substances, excipients and/or medicinal products and in development of control 5methods6
Several years of experience in one or more of the following fields:7
o Method development and verification in e.g. analytical or pharmaceutical development, a 8regulatory authority, an independent testing laboratory9
o Quality control of active substances, excipients and/or medicinal products10
o Market surveillance of quality of medicinal products in a regulatory authority11
o Assessment of the relevant parts of applications for marketing authorisation within a medicines 12agency13
NBC Working Party (Non-Biological Complexes)14
Terms of reference15
Elaboration and revision of monographs on non-biological complexes (e.g. nanoparticle solutions, like 16for example iron sucrose concentrated solution) allocated to the group by the Commission17
Profile for experts 18
Current expertise in the development and/or quality control of non-biological complexes and in 19development of control methods20
Access to laboratory facilities for verification of methods proposed for inclusion in monographs, 21Essential: Active involvement in drafting of texts and laboratory verification of test methods22
Several years of experience in one or more of the following fields:23
o Quality control in a pharmaceutical manufacturing setting or in an independent testing 24laboratory (e.g. Market surveillance of quality in a regulatory authority)25
o Pharmaceutical and/or analytical development related to respective formulations26
o Assessment of the relevant parts of applications for marketing authorisation within a medicines 27agency28
PAT Working Party (Process Analytical Technology)29
Terms of reference30
Review and revision of existing general monographs and chapters of existing pharmacopoeial texts in 31view of needs arising from Process Analytical Technology (PAT), Real Time release testing (RTRT) or 32Quality by Design (QbD) concepts33
Identify and discuss the implication of the above mentioned concepts on the texts of European 34Pharmacopoeia and make proposals to the Commission where needed35
Profile for experts 36
Expertise in chemical or pharmaceutical development and control methods applied during manufacture 37and to active substances or finished pharmaceutical preparations38
Several years of experience in one or more of the following fields39
2 PA/PH/SG (16) 7 FINAL SHORT
o Development of pharmaceutical preparations using PAT, RTRT or QbD concepts in an 1industrial setting2
o Assessment of the relevant parts of applications for marketing authorisation containing PAT, 3RTRT or QbD concepts within a medicines agency4
o Development of control strategies including PAT, RTRT or QbD concepts approaches for 5testing of active substances or pharmaceutical preparations6
o Development of pharmaceutical preparations using modelling and chemometrics associated 7with the analytical aspects for PAT8
POW Working Party (Powders)9
Terms of reference10
Drafting and revision of general chapters allocated to the group by the Commission in the field of 11powder characterisation12
International harmonisation of general chapters as decided by the Commission13
Profile for experts 14
Current expertise in methods for powder characterisation, related to quality control of active substances 15and excipients and in development of control methods16
Several years of experience in one or more of the following fields:17
o Quality control of active substances and excipients in a pharmaceutical manufacturing setting18
o Assessment of the relevant parts of applications for marketing authorisation19
o Market surveillance of quality in a regulatory authority20
o Development of methods for characterisation of powders in a research and development 21environment22
o Pharmaceutical quality control in an independent testing laboratory23
PRP Working Party (Precursors for Radiopharmaceutical Preparations)24
Terms of reference25
Drafting and revision of monographs allocated in the field of non-radioactive precursors for 26radiopharmaceutical preparations27
Profile for experts 28
Expertise in chemical, pharmaceutical and radiopharmaceutical methods, related to quality control of 29radiopharmaceutical preparations and their precursors30
Access to laboratory facilities for verification of methods proposed for inclusion in monographs.31Essential: Active involvement in drafting of texts and laboratory verification of test methods32
Several years of experience in one or more of the following fields:33
o Quality control of radiopharmaceutical preparations and their precursors34
o Quality control of synthetic organic and/or inorganic products in a chemical or pharmaceutical 35setting36
o Quality control in an independent testing laboratory37
o Development of analytical procedures for the control of radiopharmaceutical preparations and 38their precursors39
PST Working Party (Pesticide Residues)40
Terms of reference41
Drafting and revision of general chapters allocated to the group by the Commission in the field of 42pesticide residues43
Advising the Commission on acceptance criteria for pesticide residues to be included in monographs44
Maintenance of the list of pesticides tabled in general chapter on pesticide residues45
PA/PH/SG (16) 7 FINAL SHORT 1
Profile for experts 1
Current expertise in pesticide analysis, related to quality control of active substances and excipients and 2in development of control methods3
Access to laboratory facilities for verification of methods proposed for inclusion in monographs4
Several years of experience in one or more of the following fields:5
o Quality control for pesticide residues in herbals in a pharmaceutical or bulk manufacturing 6setting7
o Market surveillance of quality in a regulatory authority8
o Pharmaceutical quality control in an independent testing laboratory9
o Development of control methods for analysis of pesticide residues in a research and 10development environment11
SIT Working Party (Second identification test)12
Terms of reference13
To support and advise the Commission, Groups of Experts or Working Parties on revision/suppression 14of existing identification series, notably arising from the REACH regulation, as needed.15Propose to the Commission further items for the work programme (such as replacements of methods not 16in line with the available instrumentation in pharmacies or monographs with missing second 17identification)18
Profile for experts 19
pharmacists regularly involved in preparation of extemporaneous or stock preparation of medicinal 20products in community pharmacies or hospitals as well as in the analysis of the pharmaceutical 21substances used22
Pharmacists or chemists with special interest/expertise in analytical methods commonly available in 23pharmacies24
Members of regulatory authorities (e.g. National Pharmacopoeia Authorities, OMCLs)25
SRP Working Party (Special Revision Programme)26
Terms of reference27
Review of revision proposals for the related substances tests and limits in monographs allocated to the 28group by the Commission in the field of active substances29
Profile for experts 30
Current expertise in pharmaceutical analytical methods, related to quality control of active substances 31and excipients and in development of control methods32
Access to relevant parts (chemistry of the active substance) of marketing authorisation dossiers in order 33to judge the revision proposals34
Several years of experience in one or more of the following fields:35
o Scientific coordination in a regulatory authority such as a National Pharmacopoeia Authority36
o Assessment of the relevant parts (chemistry of the active substance) of applications for 37marketing authorisation38
o Market surveillance of quality in a regulatory authority39
o Method development and verification in a regulatory authority40
Industry representatives are not appointed to the SRP Working Party; they contribute by submission of 41data and interaction with the group via the Secretariat.42
ST Working Party (Standard Terms)43
Terms of reference44
Development of standard terms for dosage forms, routes of administration, containers at the request of 45Competent authorities of Member States or EMA46
2 PA/PH/SG (16) 7 FINAL SHORT
Profile for experts 1
Current expertise in pharmaceutical dosage forms2
Several years of experience in one or more of the following fields:3
o Assessment of the pharmaceutical development part of applications for authorisation of 4medicinal products5
o Development of general monographs for dosage forms (group of experts or national 6pharmacopoeia secretariat)7
o Experience in formulation of medicinal products8
Members of the working party may be from regulatory authorities (such as National Pharmacopoeia 9Authorities, medicines agencies), universities10
STA Working Party (Statistics)11
Terms of reference12
Drafting and revision of general chapters allocated to the group by the Commission in the field of 13statistical analysis14
Advising the Commission on questions related to statistics in the context of monograph elaboration by 15appropriate Groups of Experts16
Profile for experts 17
Current expertise in statistical analysis, related to quality control of active substances, excipients and 18medicinal products19
Several years of experience in one or more of the following fields:20
o Statistical analysis of results of control tests in a pharmaceutical manufacturing setting21
o Development of statistical methods applied in pharmaceutical analysis22
SUT Working Party (Sutures)23
Terms of reference24
Drafting and revision of monographs allocated to the group by the Commission in the field of sutures25
Profile for experts 26
Expertise in pharmaceutical analytical methods, related to quality control of sutures and in development 27of control methods28
Several years of experience in one or more of the following fields:29
o Quality control of sutures30
o Development of methods for control of sutures31
TCM Working Party (Traditional Chinese Medicines)32
Terms of reference33
Drafting and revision of monographs allocated to the group by the Commission in the field of herbal 34drugs and herbal drug preparations preferably based on the principle of adapting/improving existing 35monographs or methods to control herbal drugs used in Traditional Chinese Medicines (TCM)36
Drafting general chapters related to the specific needs of TCM herbal drugs37
Profile for experts 38
Current expertise in pharmaceutical analytical methods, related to quality control of herbal drugs and 39herbal drug preparations and in development of control methods40
Access to laboratory facilities for verification of methods proposed for inclusion in monographs41
Several years of experience in one or more of the following fields:42
o Quality control of herbal drugs/herbal drug preparations in a manufacturing setting43
o Pharmaceutical quality control of herbal drugs and herbal drug preparations in an independent 44testing laboratory45
PA/PH/SG (16) 7 FINAL SHORT 1
o Development of methods for control of herbal drugs1
o Involvement in market surveillance or regulatory oversight of imported TCM herbal drugs2
Essential: Active involvement in drafting of texts and laboratory verification of test methods for TCM 3herbal drugs4
Development of chromatographic separation systems for herbal drug constituents5
Knowledge in cultivation, harvesting, processing and use of TCM herbal drugs6
VIT Working Party (Vitamins)7
Terms of reference8
Drafting and revision of monographs allocated to the group by the Commission in the field of vitamins9and vitamin derivatives10
Profile for experts 11
Current expertise in pharmaceutical analytical methods, related to quality control of vitamins and 12excipients and in development of control methods. The need of a specialist for vitamin D type 13substances is highlighted14
Access to laboratory facilities for verification of methods proposed for inclusion in monographs,15Essential: Active involvement in drafting of texts and laboratory verification of test methods16
Several years of experience in one or more of the following fields:17
o Quality control of vitamins in a pharmaceutical or bulk manufacturing setting18
o Market surveillance of quality in an official control laboratory for medicines19
o Pharmaceutical quality control in an independent testing laboratory20
o Development of methods for control of vitamins in a research and development environment21
o Method development and verification in a national pharmacopoeia laboratory22
VSADM Working party (Vibrational Spectroscopy and Analytical Data Modelling)23
Terms of reference24
Drafting and revision of general chapters allocated to the group by the Commission in the field of:25
o Chemometrics, i.e. modelling of analytical data (e.g. Multivariate Data analysis , Data mining, 26Chemical imaging etc.)27
o measurement techniques relying extensively on analytical data modelling (NIR, RAMAN) or 28other vibrational spectroscopies ( IR)29
o provide support to the PAT WP where PAT/ QbD elements of the above mentioned chapters 30are concerned31
Profile for experts 32
Current expertise vibrational spectroscopy related to quality control of active substances and excipients 33and in development of control methods34
Several years of experience in one or more of the following fields:35
o Use of near infrared spectrometry and other vibrational spectroscopic techniques for quality 36control in a pharmaceutical manufacturing setting37
o Development of pharmaceutical control methods using near infrared spectrometry and other 38vibrational spectroscopic techniques or chemometrics in a research and development 39environment40
o Assessment of applications for marketing authorisation41
o Market surveillance of quality in of texts42
o Pharmaceutical quality control in an independent testing laboratory43
WAT Working Party (Water)44
Terms of reference45
2 PA/PH/SG (16) 7 FINAL SHORT
Drafting and revision of monographs and general chapters allocated to the group by the Commission in 1the field of water2
International harmonisation of monographs and general chapters as decided by the Commission3
Profile for experts 4
Current expertise in analytical methods applicable in water analysis in development of control methods5
Several years of experience in one or more of the following fields:6
o Quality control of water in a pharmaceutical manufacturing setting7
o Inspection of manufacturing sites8
o Pharmaceutical quality control in an independent testing laboratory9
o Development of methods for control of pharmaceutical waters in a research and development 10environment11
12