gmp supervision applications of turkey

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T.R.MINISTRY OF HEALTH

DIRECTORATE OF THE SUPERVISORY BOARD

GMP SUPERVISION GMP SUPERVISION APPLICATIONS OF TURKEYAPPLICATIONS OF TURKEY

Expert Pharmacist Sibel GÜRERAssistant Chairman of the SupervisoryAssistant Chairman of the Supervisory

BoardChief Supervisor

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PRESENTATION PLAN-1

DECREE LAW NO. 663 ON STRUCTURE AND DUTIES OF THE MINISTRY OF HEALTH AND AFFILIATED INSTITUTIONSTRANSITION PERIODTRANSITION PERIODDEFINITIONORGANIZATIONAL SCHEMEDIRECTORATE OF THE SUPERVISORY BOARD

Mission Vision Our Basic ValuesDUTIES OF THE HEAD OF THE SUPERVISORY BOARDPROCEDURE OF BEING ASSIGNED AS AN INSPECTOR AND THE REQUIRED SKILLSINTRA-SERVICE TRAINING OF THE INSPECTORSGMP SUPERVISIONSFACILITIES BEING SUPERVISED-SUPERVISIONS IN TURKEYTYPES OF SUPERVISION

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PRESENTATION PLAN-2

GMP SUPERVISION PROCESS IN TURKEYRESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CARRIED OUT IN TURKEYCARRIED OUT IN TURKEYFACILITIES BEING SUPERVISED-SUPERVISIONS ABROADISSUES TO BE CONSIDERED DURING ASSIGNMENTARRANGEMENT OF THE SUPERVISION APPLICATIONSCONDUCTING OF FOREIGN GMP SUPERVISION ASSIGNMENTS BY THE CHAIRMAN-COMPUTER PROGRAM USED IN THE FOREIGN ASSIGNMENTSGMP SUPERVISION PROCESS ABROADRESULTS OF THE REPORTS REGARDING THE SUPERVISIONSRESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CONDUCTED ABROADFACTORS EFFECTING THE SUPERVISION PROCESS

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DECREE LAW NO. 663

‐ Official Gazette No. 28103 dated 02.11.2011

Decree Law No 663 On Structure and Duties of The Ministry of Health and- Decree Law No. 663 On Structure and Duties of The Ministry of Health andAffiliated Institutions

Turkish Drug and Medical Device InstitutionARTICLE 27- Turkish Drug and Medical Device Institution has been establishedwith the duty to make regulations on medicines, active and supplementary materialsused in production of medicines, substances which are subject to national andinternational control, medical devices, extra-corporeal medical diagnostic devices,traditional herbal medical products, cosmetic products, homeopathic medicalproducts and dietetic food for special purposes and this institution is working underh Mi i i h i i b d d i i bli d i i ithe Ministry, it has its own private budget and it is a public administration.

- The authority to supervise regarding the products covered by its field of duty.

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TRANSITION PERIOD

• PROVISIONAL CLAUSE 1- Ministry and the related institutionsharmonize their structure and the personnel with the provisions of thepresent Decree Law at most within one year. Until the personnel is harmonized with the present decree law, duties given to the Ministry andthe affiliated institutions will be realized by units and personnel that havebeen doing these duties in the past; and expenses and the payments willcontinue to be made from the relevant budget.

• PROVISIONAL CLAUSE 2- The regulatory operations mentioned in thisdecree law shall come into force at most within a year as of the date of

bli ti f thi ti l U til th id l ti i t fpublication of this article. Until the said regulations come into force, application of the provisions of the current regulations, which are not violating the current Decree Law, shall continue to be applied.

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- Until the personnel of our ministry and that of the affiliatedinstitutions are harmonized with the provisions of this Decree Lawinstitutions are harmonized with the provisions of this Decree Law,(with the condition to be limited to a year) operations andtransactions shall be realized by units which were realizing thesame in the past and the personnel under the same name of the unitand under the same personnel title.

- Current situation; Decree Law No. 181;

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DEFINITION

Investigation: As a concept it is used as an examination tounderstand the original, the right version of doing things or tounderstand the original, the right version of doing things or tounderstand whether things are done right.

Ministry of Health assigned Head of the Supervision Board toconduct the investigations.

Investigators conduct the supervisions.

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MINISTER

Head of theSupervisory Board

Higher Board of Health Private Secretariat

Board of Specialty in Medicine

Prof. Dr. Nihat TOSUNMedicine

UNDERSECRETARY

Press Consultancy

Asst. Prof. Turan BUZGAN Ö.Faruk KOÇAK Dr. Ekrem ATBAKAN Dr. Yasin ERKOÇ

A i t t C lt tAssistant Consultant Assistant Consultant Assistant Consultant Assistant Consultant

• General Directorate of Personnel

•General Directorate of Health of Customsand Coasts

• Department Head of Public PrivatePartnership

• Coordinatorship of Family Practice

•General Directorate of Treatment Services• General Directorate of Construction andRepair

• General Directorate of the EU Coordination

•General Directorate of Foreign Affairs

• Project Management Support Unit

• Volunteer Health Observers

• SGK-SUT Relationship

• Unit of Law Draft Written Questions • Legal Consultancy Department

•Drug and Pharmacist General Manager

• Head of Administrative and Financial Affairs

• SABİM

• Coordinatorship of Transition in Health

• Strategy Development Directorate

• Basic Health Services General Manager

• Head of Department of the Fight Against Cancer

• Head of Department of the Fight AgainstTuberculous

• Head of Department of the Fight Against Malaria

• General Directorate of AÇSAP

• Head of R.Saydam Public Hygiene Center

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ORGANIZATIONAL SCHEME

CHAIRMAN

ASSISTANT CHAIRMAN

Ankara Center of DutyChief Supervisor

SupervisorAssistant Supervisor

İstanbul Center of DutyChief Supervisor


İzmir Center of DutyChief Supervisor


Branch Directorate of Examination and

Interrogation

Branch Directorate of Administrive andFinancial Affairs

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MISSIONFor the basic purposes of protecting the public health anddeveloping health services; in order to make the health sectoract in a more efficient, productive, good quality, economicaland legal way;and legal way;

To make supervisions by effectively using the modern supervision methods and techniques,

To contribute to the creation of new policies for the healthsectorsector,

To act as a pioneer for training professional administrators andsupervisors in the health sector

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VISION

With personnel, who have specialized in their fields and whohave higher ethical values, to become;have higher ethical values, to become;

Principled,Objective,Fair,Effective,Reliable,Guiding and respective board.

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OUR BASIC VALUES

LegalityObjectivity

Being Open to NoveltiesVocational ConfidentialityObjectivity

HonestyIndependenceVocational EfficiencyQuality and Effectiveness

Vocational ConfidentialityMutual RespectParticipating and SharingManagement Pioneering and Guidance

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DUTIES OF THE HEAD OF THE SUPERVISORY BOARD

Directorate of the Supervisory Board realizes the below-mentionedduties upon receiving orders or approval of the Minister:

To conduct all kinds of investigation, examination and interrogationoperations regarding all activities and operations of the institutionsunder the Ministry and within the organization of the Ministry,

To prepare the necessary proposals and to submit them to theMinister to better realize the purpose of the Ministry and to enable itMinister to better realize the purpose of the Ministry and to enable itto function in accordance with the legislation, plan and program,

To conduct other duties given with a special law.

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PROCEDURE OF BEING ASSIGNED AN INSPECTOR AND THE REQUIRED SKILLS

Graduated as a doctor, dentist, pharmacist, chemical engineer, chemist or received a bachelors degree in the field of law, politics, economics and business administration.

Score Limit of KPSS and Foreign Language Examination

Exam with Two Stages (Written and Oral)

ASSISTANT SUPERVISOR

Training Period for 3 Years

1. Semester (6 months) 2. Semester (1.5 years) 3. Semester (1 year)

Proficiency Exam with Two Stages (Written and Oral)

SUPERVISOR

Working for 10 years for the board, seniority, vocational qualification, effort and success

CHIEF SUPERVISOR05/12/2011 14

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INTRA-SERVICE TRAINING OF THE INSPECTORS

Informative meetings organized periodically by the Directorate ofSupervisory Board, to which only the supervisors attend,In-service trainings organized by the Directorate of the Supervisory Boardperiodically, to which all the supervisors attend; moreover, to whichparticipation of specialists from universities, Ministry of Health as well asother public and private institutions is provided,Other trainings organized with the legislation meetings conducted by otherunits of the Ministry of Health,Trainings organized abroad,Participation to the GMP and GDP training meetings, organized byParticipation to the GMP and GDP training meetings, organized byaccredited institutions,To make examination and research about issues related to the fields of dutyof the supervisors and to send them to institutions abroad to increase theirvocational knowledge.

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GMP SUPERVISIONS

Supervisions regarding the medical industry are being made according tothe provisions of the legislation consisting of the GMP rules since01/11/198401/11/1984.It has been decided with the Regulatory Approval dated 03.03.1994 that theGMP Guide should come into force as of 01/01/1995.Afterwards, in order to harmonize the GMP legislation with the EMA andFDA standards, considering the EMA directives and ICH guides, GMPguide has been revised by the General Directorate of Pharmaceuticals andPharmacy and it has come into force with the Regulatory Approval dated11/05/2009.Good Manufacturing Practices (GMP) guide has been updated by GeneralDi t t f Ph ti l d Ph d it h i t fDirectorate of Pharmaceuticals and Pharmacy and it has come into forcewith the Regulatory Approval dated12/08/2011 and numbered 7155. On15/08/2011 it has been published IEGM on the website www.iegm.gov.tr.

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FACILITIES BEING SUPERVISED

Supervisions in Turkey:

Medication manufacturing facilities,

Active ingredient manufacturing facilities,

Biological medical product manufacturing facilities,

Radio-pharmaceutical manufacturing facilities,

Medical gas production, filling, storage and distribution facilities,Medical gas production, filling, storage and distribution facilities,

Cord blood banks,

Stemcell centers,

Pharmaceutical warehouses of the representatives.

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TYPES OF SUPERVISION

Inauguration supervisions,

Deficiency-monitoring supervisions,

Additional activity application supervisions,

Periodical supervisions (3 years),

Supervisions made upon complaints,

Supervisions made upon withdrawal,Supervisions made upon withdrawal,

Supervisions on foreign manufacturing places and active ingredient (for

bio-technological products) manufacturing places.

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GMP SUPERVISION PROCESS IN TURKEY

General

• Application is filed before the General Directorate of Pharmaceuticals and Pharmacy of the Ministry by the authorities of the companies which want to enter into service/provide additionalservice.

• Said applications are examined by the General Directorate ofDirectorate of

Pharmaceuticalsand Pharmacy

• Said applications are examined by the General Directorate of Pharmaceuticals and Pharmacy and all the documents related to theapplications are sent to the Directorate of the Supervision Board in the enclosure of a cover letter.

• Relevant documents are sent to the Directorate of the SupervisionBoard regarding issues of deficiencies, periodical supervisions, complaints and withdrawal.

• The letter received from IEGM and all its enclosures are sent to the relevantAssistant Chairman of the Supervisory Board.

• Necessary examination is made on the letter and its enclosures by the AssistantChairman of the Supervisory Board. Assistant Chairman assigns thesupervisor/supervisors.

Head of theSupervisory

Board

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• Supervisor/supervisors make an examination on the workorder and the enclosed documents.

• Supervision process• Reporting Process; Examination Report is prepared and it is

submitted to the Directorate of the Supervisory Board togetherwith its enclosures.

Head of Supervisor

• Reports are examined and evaluated by the relevant AssistantChairman.

• If found appropriate, it is sent to the General Directorate of Pharmaceuticals and Pharmacy in the enclosure of the letter of the Ministry.


• Reports are read and evaluated and then being processed.Reports are read and evaluated and then being processed. Results of the audit are reported to the company beingsupervised as well as the Health Directorate of the provincewhere the company is located.

• Things such as preparing permission document, putting an annotation on the permission document of the additionalactivity and suspension of the document. Correspondencesregarding the said transactions of IEGM are done through theProvincial Health Directorates.

General Directorateof Pharmaceuticals

and Pharmacy

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• Deficiencies mentioned in the report of the supervisorare announced both to the Provincial HealthDirectorates and the company realizing thesupervision.

General Directorateof Pharmaceuticals

and Pharmacy

• Deficiencies determined during supervision aresatisfied and an application is filed before theProvincial Health Directorate. Company

• Upon application of the company, stating that it satisfied the deficiencies, in accordance with the letterreceived from IEGM, a report is prepared regardinghow the deficiencies have been satisfied in the companyand it is reported to IEGM.

Provincial HealthDirectorate

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• For a new supervision at the company or evaluation of the provingdocuments regarding the deficiencies (in accordance with thejudgment mentioned in the report), letter of the Provincial HealthDirectorate and its enclosures are examined and sent to theDirectorate of the Supervisory Board.

General Directorate of Pharmaceuticals and

Pharmacy

• Necessary examination is made on the letter and its enclosures bythe Assistant Chairman of the Supervisory Board. AssistantChairman/Chairman assigns the supervisor/supervisors to make thes per ision/e al ation

Head of thesupervision/evaluation. Supervisory Board

• According to the results of the supervision/evaluation carried out bythe supervisors, the report/letter is forwarded to the Directorate of the Supervisory Board in written.

Supervisor

• Reports/letters are examined and evaluated by the relevant AssistantChairman.

• If reports/letters are found appropriate, they are sent to the General Directorate of Pharmaceuticals and Pharmacy in the enclosure of theletter of the Ministry so that the necessary operations can be done.


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RESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CARRIED OUT IN TURKEY

A- Inauguration-Additional Activity Supervisions;

It is suggested that the company can start theactivities/additional activities it mentioned in its applicationand permission document can be prepared for these activities,

If there are deficiencies which prevent it to act, the company issupervised again/document is considered again and then it canbe decided whether the firm can start its activities/additionalactivities,

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RESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CARRIED OUT IN TURKEY

B- Periodical Supervision- Supervisions Made Upon Complaint andWithdrawal;

It i t d th t th i t d b k t t it ti itiIt is suggested that there is not any drawback to prevent its activities,Although there is not any drawback to prevent it from continuing itsactivities, there are deficiencies which need to be satisfied and theyshould be satisfied (Upon sending of the proving documents, they can beevaluated by the Supervisor, another Supervisor audit and it can be left tothe next supervision),Until the violations in the permissions of the facilities are satisfied, theyare suspended or the permissions are canceled completely for all or someare suspended or the permissions are canceled completely for all or someactivities,Application of administrative and judicial operations,

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FACILITIES BEING SUPERVISED

Foreign Supervisions:

Humanitarian medical product manufacturing facilities,

Active ingredient manufacturing facilities (forbiotechnological products).

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ISSUES TO BE CONSIDERED DURING ASSIGNMENT

1- Being fair,2- To provide priority, very fast supervision of very critical-critical

group of medicines,3- To assign the personnel based on the date of receipt of the

applications by the Ministry, which are included in the sameclassification, according to the classification given by the Ministry,

4- To assign the supervisors based on the topics they have beenspecialized on,

5 T id j di ib i f h i h h h b5- To provide a just distribution of the countries where they have beenassigned and their terms of duties among the supervisors.

6-To provide that the assistant supervisors are assigned with differentsupervisors during their training term.

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ARRANGEMENT OF THE SUPERVISION APPLICATIONS

In the decision called "Scientific Criteria Suggested for GMPControl Listing" of the Licensing-Consulting Commission ofHumanitarian Medical Products formed within the GeneralHumanitarian Medical Products, formed within the GeneralDirectorate of Pharmaceuticals and Pharmacy;

Evaluation criteria have been set for the control priorities of theproducts such as 1-Very critical, 2-Critical, 3-Not critical, 4-Non-priority by classifying the same just like that.

Since every number come before the other numbers that are biggery ggthan that, the said priority listing shall be taken into consideration inthe planning to be made for the GMP supervision of the facilitiesabroad.

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ARRANGEMENT OF THE SUPERVISION APPLICATIONSLetter of the Ministry sent to the Supervisors:

Letter of the General Directorate of Pharmaceuticals and Pharmacy and theclassifications of the application files sent in the enclosure have been sentto all the supervisors;to all the supervisors;

While GMP supervision listing is being awaited by the supervisors;It has been requested that the issues mentioned in the decision called"Scientific Criteria Suggested for GMP Control Listing" of the Licensing-Consulting Commission of Humanitarian Medical Products, mentioned inthe letter written by IEGM,Date of work order is taken into consideration regarding the productsincluded in the same class,If joint supervisors have been assigned, in case of overlapping of thej p g , pp gsupervision dates because of the fact that the other supervisor has beenassigned to work with another supervisor at the said date planning shall bedone upon considering the priority listing,If the priority listing of the importing company cannot be followed becauseof problems, resulting from the importing company's excuses such as repairor holiday at the facilities to be supervised, this fact shall be reported to theMinistry in written, including the correspondences made with the exportingcompany,

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CONDUCTING OF FOREIGN GMP SUPERVISION ASSIGNMENTS BY THE CHAIRMAN

In the letter received from the General Directorate ofPharmaceuticals and Pharmacy; information regarding the name ofthe importing company name(s) of the product(s) subject tothe importing company, name(s) of the product(s) subject tosupervision, form of the pharmaceutical, the production facility tobe supervised and the country where the facility is located as well asthe classification information of the products.

The received letters shall be recorded by the document unit of theDirectorate of the Supervisory Board and then shall be sent to thep yrelevant Assistant Chairman.

The letters, received by the Directorate, are recorded in thecomputer media, according to the date of receipt from IEGM.

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COMPUTER PROGRAM USED IN THE FOREIGN ASSIGNMENTS

General Directorate of Drugsand Pharmaceuticals Date andNumber

Name of the CountryTo Be Supervised

SupervisionDates

Facilities to Be Supervised

ImportingCompany

Products to be Supervised Specifications of the Product

Classification of theproduct (level of

criticality)criticality)

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Listing on the table is rearranged depending on the classification of theproducts (1, 2, 3, 4 generic, first generic).

Product applications included in the same application are listed accordingto the date of the letters received from IEGM.

Scanning is made;

Re,

Name of the facilities to be supervised,

Name of the product,

Name of the country.

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As a result of the conducted scan,

It is determined whether there is any pending/assignedapplication before the Directorate of the Supervisory Boardregarding the facility for which a new supervision demandhas been filed.

Information is obtained about which supervisor it has beenInformation is obtained about which supervisor it has beengiven as a working order.

It is determined whether it is necessary to make a newassignment.

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Foreign GMP assignments made by the Ministry

1- Assignments regarding the same facility

2- Assignments regarding different facilities withinthe same country

3- Assignments made in case different stages of production are in different facilitiesproduction are in different facilities

4-Assignments regarding the biotechnologicalproducts

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1- ASSIGNMENTS REGARDING THE SAME FACILITY

Assignments Regarding the Same Facility

In those casessupervision has not

been doneDuring supervision

Upon completion of the supervision

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A- In those cases supervision has not been doneA1- If regulatory approval has not yet been received; the newly

received supervision demand is united with the working order of thisreceived supervision demand is united with the working order of thissupervisor. While uniting them, criticality levels of the products (1, 2, 3, 4,etc.) is not taken into consideration.

A2- If the regulatory approval has been received; an evaluation ismade about whether the new application is going to extend the supervisionprocess based on the pharmaceutical form of the product and upondiscussing with the supervisor.

If it is decided that the supervision period cannot be extended; thep p ;newly received supervision demand is united with the working order of thissupervisor. While uniting them, criticality levels of the products (1, 2, 3, 4,etc.) is not taken into consideration.

If it is decided that the supervision period shall be extended; adifferent supervisor can be assigned.

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B- During supervision;

Considering that there is application which shall not extend theConsidering that there is application which shall not extend theplanned supervision process, the remaining days of supervision,meeting with the supervisor(s) making the supervision,it is (not) assigned to the same supervisor.

I thi ki d f i tIn this kind of assignments;- Classification of the product and whether the importing companiesare the same are not taken into consideration.- Working order is notified to the supervisor, upon the assignment,who is abroad.

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With the products being supervised by thesupervisor in the new application;

C- Upon completion of the supervision

- Same line-Same environment,- Same equipment

Same supervisor

- Different line,- Different environment,

- Different equipment

Different/Samep

Evaluation

supervisor

Supervision

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2- ASSIGNMENTS REGARDING DIFFERENT FACILITIES WITHIN THE SAME COUNTRY

Assignment is done in a way not to be more than 3 weeks(2-3 facilities).(2 3 facilities).

Classification of the products is taken into consideration in the assignment.

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3- ASSIGNMENTS MADE IN CASE DIFFERENT STAGES OF PRODUCTION ARE IN DIFFERENT FACILITIES

A- If a supervisor has been assigned regarding one of the facilities where thereis conducted the production stages; the new working order can completelybe given to this new supervisor.

If the new work which covers different production stages does not havepriority over the work which has been assigned beforehand; productionstage is supervised regarding the facility, supervision of which has beenplanned. Supervision of the other stages is done during their ownclassification.

B- If supervision of the facilities where production stages are conducted isassigned to more than one supervisor; the new working order can be

i h i b i di id d i d igiven to these supervisors upon being divided into production stages.C- If there is not any assignment regarding the facilities, production

stages of which have been conducted; a single supervisor/team ofsupervisors can be assigned in a way to cover all the production stages.(Exception; distant countries, supervision demands regarding which arefiled very rarely)

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4- ASSIGNMENTS REGARDING THE BIOTECHNOLOGICAL PRODUCTS

Assignments Regarding the BiotechnologicalAssignments Regarding the BiotechnologicalProducts

The fact that the active ingredientproduction facility and the finishedproduct production facility are the

same

The fact that the active ingredientproduction facility and the finished

product production facility are different(two or more)

Same country Differentcountry

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A- If the active ingredient production facility and thefinished product production facility are the same (in onefinished product production facility are the same (in onefacility);

The same supervisor is assigned.

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B- If the active ingredient production facility and the finished productproduction facility are different (in 2 or more facilities);Assignment is done considering the product classification of theAssignment is done considering the product classification of thesupervision in a way to provide that it is done at the same time/close toeach other.

1- Same Country;

The same supervisor is assignedThe same supervisor is assigned.

2- Different Country;

The same supervisor and/or different supervisor is assigned.05/12/2011 42

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5- ALTERNATIVE PRODUCTION-ASSIGNMENTS REGARDING THE PRODUCTION STAGES

There is not any requirement stating that supervision of theproduction, primary packaging, etc. facilities of one productp , p y p g g, pshall be done by the same supervisors who supervise thealternative bulk production, primary packaging facilities.A- If there is a supervisor assigned for the supervision of thealternative production facility, working order can be given to thissupervisor.B-If there is a supervisor assigned for supervision in the same

t ki d b i t thi icountry, working order can be given to this supervisor,considering the classification. (If the term of duty is more than 3weeks)C- If supervisors have not been assigned for supervision in thesame facilities or in the same country; new assignment is made

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GMP SUPERVISION PROCESS ABROAD

General Directorate of

• Company's application• Examination upon application and completing the• Forwarding of the files necessary for GMP supervision regarding

the appropriate applications to the Directorate of the SupervisoryDirectorate of Pharmaceuticalsand Pharmacy

the appropriate applications to the Directorate of the SupervisoryBoard

• Necessary examination is made on the letter and its enclosuresby the relevant Assistant Chairman of the Supervisory Board.

• Paraph of the Assistant Chairman of the Supervisory Board, Head of theSupervisory

Board

p p y ,signature of the Chairman and assignment of the supervisor(s)

• Giving written working order to the supervisor

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• Examination of the working order and theenclosed files (product specifications, assignment process according to thepharmaceutical forms)

Supervisor/Supervisors

• A letter shall be written by the supervisors tothe authorities of the company; - Requestingresearch about whether there is a specialcondition regarding the supervision processesof the country which will be supervised -Moreover, asking for determination of thesupervision dates by reaching a consensuswith the authorities of the production facilitiest b i dto be supervised

• Provision of written information by theimporting company to the supervisor (date of supervision, special condition, etc.).

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• Indicating whether the date of supervision is appropriate for the supervisor by sending a letter to the importing company by thesupervisor .

• Requesting supply of the invitation letter


q g pp yfrom the foreign company, which is going tobe audited, including the road process (if thecompany does not have a special conditionfor application) .

• Provision of information to the Directorate of Supervision Board by the supervisor(s) (dateof supervision, whether the country to be visited has a special condition for application, invitation letter)invitation letter)

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Board

• Sending of the letter of the Supervisor as well as its enclosures by the Directorate of the Supervisory Board to the Directorate of Foreign Affairs of the Ministry andprovision of the regulatory approval

• Moreover, if the company has a special application condition, asking for thenecessary action to be taken

• Receiving the regulatory approval and forwarding the same to the Directorate of theGeneral

Directorate of Foreign Affairs

Receiving the regulatory approval and forwarding the same to the Directorate of theSupervisory Board


Board

• Serving of the regulatory approval to the supervisor(s)


• Buying of the tickets for the country that is going to be gone by the supervisor(s) andcompletion of the visa procedures, if necessary

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• Detailed examination of the application files in the enclosure of the working order from the date when the working order is received until the actual date of supervision by the supervisors

• Supervision process - DOF process• Reporting Process (Examination Report, abroad report.

Submission report to the Minister)• Submission of 3 reports and their enclosures together with thecover letter to the Directorate of the Supervisory Boardcover letter to the Directorate of the Supervisory Board

Head of the

• Examination and evaluation of the reports by the relevantAssistant Chairman

• If found appropriate, together with the paraph of the AssistantChairman, signature of the Chairman, in the enclosure of thecover letter; sending of the examination report to the General Head of the

SupervisoryBoard

g pDirectorate of Pharmaceuticals and Pharmacy of our Ministry, abroad report and the report to be submitted to the Minister to theHead of the Office of Foreign Affairs of our Ministry

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Pharmaceuticals and Pharmacy

• Reporting of the result of the supervision to the importing company by the General Directorate of Pharmaceuticals and Pharmacy of our Ministry (requesting of someissues such as satisfying the deficiencies, sending of the proving documents)

• Reporting of the results of supervision to the manufacturing company, which have beenreported to them by General Directorate of Pharmaceuticals and Pharmacy

ImportingCompany

• Requesting the necessary information and documents from the production company andsubmission of the same to the General Directorate


Pharmaceuticals and Pharmacy

• Sending of the documents reported to IEGM upon being provided from the productioncompany by the importing company to the Directorate of the Supervisory Board


Board

• Submission of the documents, received from the General Directorate of Pharmaceuticals and Pharmacy in the enclosure of the working order to the supervisor, who is making the supervision in order to be evaluated• Sending of the letter, consisting of the evaluation of the supervisor to IEGM for thenecessary action to be taken

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RESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CONDUCTED ABROAD-1

Production place of the product(s) which are subject to supervision areappropriate for GMP. (GMP certificate +)

Production place of the product(s) which are subject to supervision areappropriate for GMP. However, upon satisfaction of the deficienciesidentified during supervision (…. article) it is necessary for the provingdocuments to be sent to our Ministry and to be evaluated by IEGM. (GMPcertificate +)

Production place of the product(s) which are subject to supervision aregenerally appropriate for GMP. GMP certificate can be issued and thelicensing process can be finalized; however, before granting the salespermission the deficiencies, determined during the supervision, shall becompleted. Supervisor/IGM evaluation.(GMP certificate +)

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RESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CONDUCTED ABROAD-2

At the manufacturing place of the product(s), which are subject tosupervision, …..article have been determined to be deficient and thep ,production place is not appropriate for GMP.(GMP certificate -)

Production place of the product(s) which are subject to supervisionare generally appropriate for GMP. However, upon satisfaction ofthe deficiencies identified during supervision (…. article), the finaldecision shall be given upon evaluation of the proving documents bythe supervisor who did the supervision.(GMP certificate -/+ or -)

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THANK YOU FOR YOUR

ATTENTION

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gmp supervision applications of turkey

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