m. pharmacy (common to all) ii-semester (cbcs) (backlog ...gprcp.ac.in/qpmp/2016/all paqa2.pdf ·...

OU - 17

01 O

U - 17

01

Code No: 13125/CBCS

FACULTY OF PHARMACYM. Pharmacy (Common to all) II-semester (CBCS) (Backlog) Examination,

August 2019Subject: Intellectual Property Rights & Regulatory Affairs

Time: 3hrs Max Marks: 75

Note: Answer any five questions, all questions carry equal marks

1. a) Explain patent Application and patent processing. (10)b) Write a note on copyrights (5)

2. Explain in detail OECD guidelines. (15)

3. Explain the structure and functions of WTO. (15)

4. Explain in detail about FDA guidelines for submission of IND. (15)

5. Discuss in detail about schedule Y. (15)

6. Discuss ICH guidelines for quality, safety and efficacy. (15)

7. a) Explain Food Adulteration Act 1954. (10)b) Write a note on Consumers protection Act. (5)

8. (a) Explain in detail about Industrial development & regulation Act 1951. (10)(b) Write a note on MSDS preparation. (5)

************

Library G.Pulla Reddy College of Pharmacy

Hyderabad

OU - 17

01 O

U - 17

01

Code No: 13143/CBCS

FACULTY OF PHARMACYM. Pharmacy (P.A & Q.A) II Semester (CBCS)(Backlog) Examination,

August 2019Subject: Quality Control Methods

Time: 3 Hours Max Marks: 75Note: Answer any Five Questions. All Questions carry Equal marks

1. What are different analytical principles and procedures of the following reagents basedfunctional group determination 7+8a) PDAC (P-Dimethyl Amino Cinnamaldehyde)b) MBTH (3-Methl-2-Benzpthiozolyl hydra zone)

2. Explain various principles and procedures of quantitative estimation of the followingfunctional groups.a) Hydroxy 9b) Aldehyde 6

3. Write short notes ona) Bratton-Marshall reagent 7b) 2,3,5-Triphenyl tetrazolium salt. 8

4. Explain principle and procedure involved in quantitative estimation of the followingdrugs from their dosage forms. 8+7a) Ibuprofenb) Metronidazole

5. What are different quality control tests used for the following excipentsa) Disintegrating agents 8b) Preservatives 7

6. Discuss the principles and procedures of the following quality control tests. 5+5+5a) residue on ignitionb) readily carbonizable substances.c) preservative challenge test.

7. Write short notes on quantitative estimation ofa) Penicillin’s 7b) Steroids 8

8. List out and explain quality control tests of the following. 8+7a) Glass containers 8b) Plastic containers. 7

************


Hyderabad

OU - 17

01 O

U - 17

01

Code No: 13142/CBCS

FACULTY OF PHARMACYM. Pharmacy (P.A. & Q.A.) II Semester (CBCS)(Backlog) Examination,

August 2019Subject: Analytical Method Validation


1. Describe development and validation parameters of Gas chromatography. 15

2. How do you calibrate following instruments.

a) Analytical balance 7

b) UV- visible spectrophotometer. 8

3. Define and Explain the following. 3 x 5 = 15

a) Retrospective validation

b) Validation master plan.

c) Concurrent validation.

4. Explain the factors affecting Extraction of drug from biological sample and write in detailone of the extraction methods. 15

5. a) Define and explain different types of Bioanalytical validation. 9

b) Explain various parameters to be considered in Bioanalytical method validation. 6

6. Write a note on

a) AHU validation. 6

b) HVAC system validation. 9

7. a) What are the factors to be considered is Numerical calculation of limits for

cleaning process validation. 8

b) What are the methods of sterilization validation? 7

8. a) Define and Explain DQ, 1Q, 0Q and PQ 8

b) Explain validation parameters of UV-visible spectrophotometer. 7

************


Hyderabad

OU - 17

01 O

U - 17

01

Code No: 13141/CBCS

FACULTY OF PHARMACYM. Pharmacy (P.A. & Q. A.) II Semester (CBCS)(Backlog) Examination,

August 2019Subject: Biological Standardization


1. Define bioassay. Explain about the principle and procedure involved in bioassay ofDiphtheria. 15

2. Write about the principle and procedure involved in the biological tests of Endotoxins. 15

3. Write about the microbiological assay of vitamins-cyanocobalamine. 15

4. Write about the principle and procedure involved in the biological test of Histaminelike substances. 15

5. a) Discuss Biological assay of biotechnology products. 8b) Write about the biological assay of Oxytocin. 7

6. Explain briefly about the principle and procedure involved in the bioassay of hepatitisvaccine. 15

7. Write in detail evaluation of rabies vaccine and mention its applications.8. a) Write about the direct and indirect assay based on quantal response. 8

b) Explain briefly about the principle and procedure involved in the bioassay ofestrogens. 7

************


Hyderabad

OU - 17

01 O

U - 17

01

Code No: 13144/CBCS


August 2019Subject: Pharmaceutical Packaging Technology (Elective)

Time: 3 Hours Max Marks: 75Note: Answer any Five Questions. All Questions carry Equal marks1. a) Define packaging. Give importance of packaging and write the ideal properties of

a package material. (1+3+3)b) Give the components of a corrugated fiber board and write about types of it. (3+5)

2. a) Discuss various types of glasses used in pharmaceutical packaging. (7)b) Classify the plastics. Write their mechanical and physicochemical properties. (8)

3. a) Write about evaluation of the sterile product packages. (7)b) Explain the working of ampoule filling machine with a schematic diagram. (8)

4. (a) Explain in brief about tamper resistant packaging system. (7)b) Explain the working of blister packing machine with a schematic diagram. (8)

5. a) What are different types of labels? Write about barcode label and mention itsadvantages. (2+4+2)

b) Discuss about package inserts. (7)6. Write short notes on

a) Child resistant packaging. (5)b) Quality control tests for plastic containers. (5)c) Environmental considerations of packaging materials. (5)

7. a) Write the objectives and contents of a pharmaceutical label. (4+4)b) Describe briefly various hazards of packaging materials. (7)

8. a) Write the applications of collapsible tubes in pharmaceutical packaging. (7)b) Explain about different components of aerosol containers. (8)

************


Hyderabad

OU - 17

01 O

U - 17

01

Code No: 13145/CBCS


August 2019Subject: Quality assurance and management (Elective)

Time: 3 Hours Max Marks: 75Note: Answer any Five Questions. All Questions carry Equal marks1. a) Define quality assurance? Describe quality assurance for rawmaterials? 10

b) Explain quality assurance for packing materials. 52. Define qualification? Describe in detail equipment qualification. 153. Describe in detail SOPs of

a) Cleaning 5b) Compression. 5c) Sterilization using autoclave. 5

4. Describe in detail elements of TQM and add a note on new quality tools andtechniques? 15

5. a) Describe in detail modern inventory managements? 10b) Write a note on inventory valuation? 5

6. Explain the material management of following:a) Intermediate and bulk products. 5b) Recalled products. 5c) Reagents and culture media. 5

7. a) Explain in detail HVAC management in a pharmaceutical facility? 10b) Write a note on utilities management? 5

8. a) Define documentation according to ICH? Describe in detail master production andcontrol record? 8

b) Write a note on drug product inspection. 7

************


Hyderabad

OU - 17

01 O

U - 17

01

Code No: 13146/CBCS


August 2019Subject: Drug Polymer Technology (Elective)

Time: 3 Hours Max Marks: 75Note: Answer any Five Questions. All Questions carry Equal marks1. Write the classification of polymers. And discuss in brief about the critical properties

of polymers used in pharmaceutical formulations with examples. 15

2. Explain with suitable examples how the molecular weight, crystallinity and crosslinkingeffects the physical and mechanical properties of polymers. 15

3. Write a brief note on:

a) Application of biodegradable polymers in parenteral and surgical. 7

b) Biodegradble polymers mechanism of degradation and biodegradability testing. 8

4. Define the term ‘Polymer Therapeutics’. And, explain in detail the Pharmacokinetics ofany two non-biogradable polymer therapeutics. 15

5. Justify the below given statements with suitable examples:

a) Polymers can alter bio distribution if formulated into dense nano particles. 7

b) Polymers enhance hydrophobic drug bioavailability if formulated as micelles. 8

6. Explain with examples how polymeric drug delivery systems can be manipulated forpassive targeting of tumours by utilizing EPR effect. 15

7. Describe the possible bio-interaction of a polymer with the blood. And outlines theissues that must be considered when selecting a polymer for therapeutic applications.15

8. Write short notes on:

a) Polymetric Immune-Adjuvants 5

b) Stimuli Responsive Polymers. 5

c) Regularoty Challenges in Polymer Therapeutics. 5

************


Hyderabad

Library

G.Pulla Reddy College of Pharmacy

Hyderabad

OU - 17

01 O

U - 17

01

Code No. 1320 / CBCSFACULTY OF PHARMACY

M. Pharmacy (Common to All) II-Semester (CBCS) (Backlog) Examination,August 2018

Subject: Intellectual Property Rights and Regulatory Affairs

Time: 3 Hours Max. Marks: 75

Note: Answer any five questions. All questions carry equal marks.

1 Write a note on :(a) Patent filing procedures (10)(b) Trademark (5)

2 Discuss in detail schedule ‘M’ as per Drugs and cosmetics Act and Rules. (15)

3 Discuss indetail about ICH guidelines. (15)

4 (a) Explain in detail Regulation of import and export of drugs. (8)

(b) Write a note on submission of marketing application of India. (7)

5 (a) Discuss in detail FDA guidelines on NDA. (10)

(b) Write a note on Generic Drug products. (5)

6 (a) Write a note on Industrial safety. (10)

(b) MSDS preparation (5)

7 (a) Discuss the objectives and functions of WIPO. (10)

(b) Write a note on TRIPS. (5)

8 Write a note on :(a) Industrial effluent testing and treatment (7)

(b) Control of Environmental pollution (8)

*****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01


M. Pharmacy (P.A. & Q.A.) II-Semester (CBCS)(Backlog) Examination, August 2018

Subject: Biological StandardizationTime: 3 Hours Max. Marks: 75


1 (a) Define bioassay. Explain about the principle and procedure involved inBioassay of Heparin. (8)

(b) Write about the principle and procedure involved in biological tests forLiving contaminants in vaccines. (7)

2 (a) Write about the microbiological assay of vaccine – Diptheria. (8)(b) Write about the microbiological assay of antibiotics – neomycin sulfate. (7)

3 Write about the microbiotics assay of vitamins – Cyanocobalamine. (15)

4 Explain about the principle and procedure involved in bioassay of insulin. (15)

5 (a) Briefly explain about the blood related products. (7)(b) Write about the human blood coagulation factors. (8)

6 Write about the biological assay of tetanus antitoxin. (15)

7 Write about the Biological assay of biotechnology product of erythropoietin. (15)

8 (a) Write about Direct and Indirect assay based on quantal response. (7)(b) Explain briefly about the principle and procedure involved in the bioassay

of estrogens. (8)

*****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01


M. Pharmacy (P.A. & Q.A.) II-Semester (New)(Main) Examination, October 2016

Subject: Quality Control MethodsTime: 3 Hours Max. Marks: 75


1 What are the principles and procedures involved in the quantitation estimationof the following:(a) fluoroquinolones (7)(b) Steroids (8)

2 Explain analytical principles and procedures of the following reagents basedfunctional and group determination :(a) Folin-Cicocastern )FU) reagent (8)(b) PDAB (P-Dimethyl amino benzaldehyde) (7)

3 Write a note on :(a) Bratton – Marshall reagent (7)(b) 2, 3, 5 – Triphenyl tetrazolium salt (8)

4 Explain principle and procedure involved in quantitation estimation of thefollowing: drugs in their dosage forms(a) Indomethacin (8)(b) Propranalel (7)

5 Write a note on :(a) Particle size distribution (8)(b) Preservative challenge test (7)

6 Discuss the principles and procedures of the following quality control tests:(a) loss on drying (5)(b) residue on ignition (5)(c) readily oxidizable substances (5)

7 Explain principles and procedure of quantitative estimation of the followingfunctions groups(a) Hydroxy (9)(b) Amine (6)

8 Write a note on physiochemical tests of the following:(a) polyethylene containers (8)(b) metal containers (7)

*****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01


M. Pharmacy (P.A. & Q.A.) II-Semester (CBCS)(Backlog) Examination,August 2018

Subject: Analytical Method ValidationTime: 3 Hours Max. Marks: 75


1 Describe method development and validation parameters for a new analyticalmethod. (15)

2 How will you calibrate following instruments: (8+7)(a) GC-MS(b) UV-visible spectrophotometer

3 Define and explain the following:(a) Retrospective validation (5)(b) Validation protocol (5)(c) Concurrent validation (5)

4 Explain the factors affecting extraction of drug from biological sample anddifferent mechanisms of SPE (solid phase extraction) (15)

5 (a) Define and explain : (6)(i) Full validation(ii) Partial validation(iii) Cross validation

(b) Explain various parameters in Bio-analytical method validation. (9)

6 Write a note on :(a) AHU validation (6)(b) HVAC system validation (9)

7 (a) What are the factors to be considered in setting limits of chaning processvalidation ? (8)

(b) What parameters to be considered in sterilization validation. (7)

8 (a) Define and explain DQ, IQ, OQ and PQ. (8)(b) Explain parameters of FT-IR validation (7)

*****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01


M. Pharmacy (P.A. & Q.A.) II-Semester (CBCS) (Backlog) Examination, August 2018

Subject: Pharmaceutical Packaging Technology (Elective)

Time: 3 Hours Max. Marks: 75


1 (a) Define packaging. Write the ideal properties of a packaging material. (1+4)

(b) Explain about various types of inner and outer packages. (10)

2 (a) Discuss various types of glasses used in pharmaceutical packaging. (8)

(b) Explain different quality control tests for paper and paper board. (7)

3 (a) Discuss about different types of containers used to pack sterile pharmaceuticalproducts. (10)

(b) Write about evaluation of sterile product packages. (5)

4 (a) Explain the working of liquid filling machine with a schematic diagram. (8)

(b) Discuss in brief about child resistance packaging technology. (7)

5 (a) Write the objectives and contents of a pharmaceutical label. (3+4)

(b) What are different types of labels? Write about structured product label. (8)

6 (a) Explain about different components of aerosol containers. (8)

(b) Discuss about flexible packaging materials in brief. (7)

7 Write short notes on :(a) General principles of sterile product packaging (5)

(b) Recycling of packaging materials (5)

(c) Hazards encountered by the package during storage and distribution (5)

8 (a) Explain the working of strip packaging machine with a schematic diagram. (8)

(b) Describe the metallic containers applications in pharmaceutical packaging. (7)

*****Library G.Pulla Reddy College of Pharmacy

Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01


M. Pharmacy (Pharmaceutics/P.A. & Q.A.) II-Semester (CBCS)(Backlog) Examination,August 2018

Subject: Drug Polymer Technology (Elective)Time: 3 Hours Max. Marks: 75


1 Write the classification of polymers. Discuss in brief about the critical properties ofpolymers used in pharmaceutical with examples. (15)

2 Explain with suitable examples how the molecular weight, crystallinity andcrosslinking effects the physical and mechanical properties of polymers. (15)

3 Write a brief note on :(a) Application of biodegradable polymers in parenteral and surgical. (7)(b) Biodegradable polymer mechanism of degradation and biodegradability

testing. (8)

4 Define the term ‘Polymer Therapeutics’. And , explain in detail the pharmacokineticsof any two non-biodegradable polymer therapeutics. (15)

5 Justify the below given statements with suitable examples:(a) Polymers can alter bio-distribution if formulated into dense manoparticles (7)(b) Polymers enhance hydrophobic drug bioavailability if formulated as micelles. (8)

6 Explain with examples how polymeric drug delivery systems can be manipulated forpassive targeting of humors by utilizing EPR effect. (15)

7 Describe the possible bio-interaction of a polymer with the blood. And outlines theissues that must be considered when selecting a polymer for therapeuticapplications. (15)

8 Write short notes on : (5x3)(a) Polymeric Immune-Adjuvants(b) Stimuli Responsive Polymers(c) Regulatory Challenges in Polymer Therapeutics

*****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01


M. Pharmacy (P.A & Q.A) II – Semester (CBCS) (Backlog) Examination, August 2018Subject: Quality Assurance and Management (Elective)

Time: 3 Hours Max.Marks: 75

Note: Answer any Five questions. All questions carry equal marks.

1 Explain the concept of quality assurance, GMP and quality control. Discuss the primaryfunctions of quality assurance and what is the role of QA in implementing GMP. 15

2 a) Discuss the quality assurance for raw materials, APIs, and packing materials. 10b) Write a note on change control. 5

3 a) Discuss the principles and elements of TQM. 6b) Discuss the standard operating procedures for cleaning and compression. 9

4 a) Define the following DQ, IQ, OQ and PQ. 8b) Explain in detail operational and performance qualification. 7

5 a) Define the following, safety stock, lead time, reorder time. 6b) Describe in detail various inventory models. 9

6 a) Describe the functions of material management. 5b) Explain the purchasing cycle of and procedures for the materials / items in an

industry. 10

7 a) Describe the qualification, experience and responsibilities of key personnel in humanresource department. 10

b) Define training. Explain the importance and training and development and what areall the different steps involved in training. 5

8 a) Explain the difference between mater formula and batch formula record. 5b) Describe the importance of documentation and records in a pharmaceutical industry. 10

****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01

Code No. 4112 / NFACULTY OF PHARMACY

M. Pharmacy (Common to All) II-Semester (New)(Main) Examination, October 2016

Subject: Intellectual Property Rights and Regulatory AffairsTime: 3 Hours Max. Marks: 75


1 (a) What is a Patent? Explain the procedure for filing an application for patent inIndia. (10)

(b) Write briefly about trademarks and their uses. (5)

2 (a) Discuss the objectives and functions of WTO. (9)(b) Explain the importance of TRIPS on Indian pharmaceutical industry. (6)

3 Write a detailed note on requirements and guidelines of GMP (schedule M) inPharma industries. (15)

4 Discuss the ICH guidelines in detail with reference to registration of pharmaceuticalsglobally. (15)

5 Discuss the salient features of documentation required for submission of NDA. (15)

6 Write short notes on :(a) Material safety data Street (MSDS) (5)(b) OECD guidelines for clinical studies (5)(c) Generic products (5)

7 Discuss the salient features of pollution control regulation. (15)

8 Explain in detail about export and import of drugs. (15)

*****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01


M. Pharmacy (P.A. & Q.A.) II-Semester (New)(Main) Examination, November 2016

Subject: Biological StandardizationTime: 3 Hours Max. Marks: 75


1 (a) Define Bioassays. Discuss the bioassay of Insulin. (7)(b) Write the principle and procedure involved in the bioassay of Heparin

sodium injection. (8)

2 (a) Explain the tests for the absence of mycoplasmas in vaccines. (7)(b) Discuss the evaluation of efficacy of vaccines and immunosera. (8)

3 (a) Write the principle and method involved for the microbiological assay ofNeomycin sulfate. (8)

(b) Discuss the biological assay of diphtheria vaccine. (7)

4 (a) Write about the various methods of bioassay for agonist. (8)(b) Discuss the statistical principle used in the bioassays. (7)

5 (a) Explain the production and tests for Anti blood grouping serum. (7)(b) Write the principle and procedure involved in the bioassay of

erythropoietin. (8)

6 (a) Discuss the bioassay of Interferons. (8)(b) Write the principle and procedure involved in the bioassay of any one

blood coagulation factor. (7)

7 (a) Explain the properties and tests for bacterial pyrogen and endotoxins. (8)(b) Discuss the methods involved in the evaluation of oxytocin. (7)

8 (a) Write the principle and procedure involved in the biological tests for livingcontaminants in vaccines. (8)

(b) Explain the microbiological assay of cyancobalamine. (7)

*****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01



Subject: Quality Control MethodsTime: 3 Hours Max. Marks: 75


1 (a) Define Congealing range. Write a brief note on the determination of congealingrange as per I.P. with applications.

(b) Explain the role of pH in quality control tests for excipients and the methods todetermine the same.

2 (a) Explain the procedure for quality control tests of metal container for eyepreparations.

(b) Write a note on customized patient medication packages.

3 (a) Describe the official methods for determination of LOD as per IP.(b) Write a brief note on light Transmission Test and Chemical resistance test of

glass containers.

4 Describe various analytical principles, procedures and applications involved in theuse of the following reagents.(i) MBTH (ii) 1, 2, - Napthoquinone – 4 - Sulfonate

5 Write briefly on the following control standards and assay of propronal and Levodopaas per I.P.

6 Describe different analytical principles and procedures involved in the quantificationof following functional groups.(a) Carboxyl (b) Aldehyde (c) Hydroxy

7 Discuss the principles, procedures and application of the following reagents inanalysis of pharmaceutics(i) Folin – ciocalter (FC) reagent(ii) P-Dimethyl amino benzeldehyde (PDAB) reagent(iii) Bration Marshell reagent

8 Write the principle and procedure involved in the quantitative analysis of thefollowing drugs(a) Indomethacin(b) Tinidazole(c) Erythromycin

*****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01



Subject: Analytical Method ValidationTime: 3 Hours Max. Marks: 75


1 Explain various parameters in analytical procedure validation. (15)

2 (a) Define Qualification and Calibration. (5)(b) Describe calibration of Analytical Balance (5)(c) Write a note on SPE (5)

3 Define and explain the following:(a) Prospective validation (5)

(b) Concurrent validation (5)(c) Revalidation (5)

4 Explain analytical method development and validation of UV-visiblespectrophotometers. (15)

5 (a) What are the factors to be considered in selection of a biological sample forquantification? (8)

(b) Explain principle and procedure of extraction of drug from biological sampleby membrane filtration. (7)

6 (a) Describe pharmaceutical water system validation. (8)(b) Discuss steps involved in validation master plan. (7)

7 (a) What are the factors to be considered in setting the limits of changingprocess validation? (7)

(b) What are the parameters to be considered in sterilization validation? (8)

8 (a) Define and explain DQ, IQ, OQ and PQ. (8)(b) Write the parameters to be considered for FT-IR validation. (7)

*****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01


M. Pharmacy (P.A. & Q.A./Pharmaceutics) II-Semester (New)(Main) Examination,November 2016

Subject: Drug Polymer Technology (Elective)Time: 3 Hours Max. Marks: 75


1 (a) Describe bulk and suspension polymerization methods of preparation ofpolymers? (8)

(b) Explain solid state properties of polymers. (7)

2 Describe thermodynamics of polymeric solutions. (15)

3 (a) Classify biodegradable polymers. Write in detail properties of any threebiodegradable polymers. (7)

(b) Describe the biodegradability testing of polymers. (8)

4 (a) Explain in detail biological response modifiers. (10)(b) Describe applications of polymers in parenterals, surgical and other novel

drug delivery system. (5)

5 Describe ADME of polymer therapeutics. (15)

6 Write notes on :(a) polymeric immune adjuvants (5)(b) polymers as stimuli responsive systems (5)(c) polymers in intracellular drug delivery (5)

7 (a) Describe in detail regulatory challenges of polymer conjugates in polymertherapeutic. (10)

(b) Write a note on enhanced permeation and retention effect (EPR). (5)

8 (a) Explain in detail site targeting using polymer conjugates. (7)(b) Write a note on different methods of preparation of microspheres? (8)

*****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01


M. Pharmacy (P.A. & Q.A.) II-Semester (New)(Main) Examination, November 2016

Subject: Pharmaceutical Packaging Technology (Elective)Time: 3 Hours Max. Marks: 75


1 (a) Explain about primary, secondary and tertiary packaging materialsclassification. (8)

(b) Write a short note on types of Caps and closures. (7)

2 Describe about classification and physico-chemical properties and application ofplastic packaging materials. (8+5+2)

3 Describe about classification and physico-chemical properties and applicationof glass packaging materials. (8+5+2)

4 Write a short note on :(a) objectives and contents of a pharmaceutical label (7)(b) Different types of pharmaceutical labels. (8)

5 Write a short note on :(a) Types of closure used for a sterile products (8)(b) Write about packaging materials recycling process. (7)

6 Write a short note on :(a) Aerosol packaging (8)(b) Blister packaging (7)

7 Write a short note on :(a) Solid filling technique as machinery (8)(b) Strip packaging techniques (7)

8 Write a short note on :(a) Form, Fill and Seal machinery (8)(b) Capping machine (7)

*****


Hyderabad

Library


Hyderabad

OU - 17

01 O

U - 17

01


M. Pharmacy (P.A & Q.A) II – Semester (New) (Main) Examination, November 2016Subject: Quality Assurance and Management (Elective)

Time: 3 Hours Max.Marks: 75Note: Answer any Five questions. All questions carry equal marks.

1 Explain the difference between quality assurance, GMP and quality control. Discuss theprimary functions of quality assurance and what is the role of QA in implementing GMP. 15

2 a) Discuss the quality assurance of buildings and facilities. 10b) Write a note on new quality tools and techniques. 5

3 a) Define TQM. What do you know about continuous improvement and learning? 6b) Write the standard operating procedures for disinfection and moist heat sterilization. 9

4 a) Describe in detail equipment qualification. 8b) How the rejected and recovered materials are managed in a pharmaceutical

industry. 7

5 a) Define the following – safety stock, lead time, reorder time. 8b) What do you mean by inventory turnover ratio? Describe ABC analysis. 7

6 a) Describe the functions of material management. 5b) How the HVAC facilities are managed in a pharmaceutical industry. 10

7 a) Describe the qualification, experience and responsibilities of key personnel in humanresource department. 10

b) Define training. Explain the importance of training and development and what are allthe different steps involved in training. 5

8 Write a note on following:a) Expiration dating 4b) Examination of labels 4c) Sanitation of manufacturing premises 4d) Master formula record 3

****


Hyderabad

m. pharmacy (common to all) ii-semester (cbcs) (backlog ...gprcp.ac.in/qpmp/2016/all paqa2.pdf ·...

Documents