QUALITY ASSURANCE AND MANAGEMENT M PAQ. T.1.

204 Sessional: 30 Examination: 70 Period/week: 4 Duration of Exam: 3 hrs Nature of Exam: Theory

UNIT I Basic Concepts of Quality Assurance: Quality control and quality assurance, definition, concept, philosophy, concept of total quality management, functions, sources of variation, change control program. NABL certification and accreditation procedure, quality audits, EQ (DQ, IQ, OQ &PQ), process validation (PV) (prospective, retrospective and concurrent). UNIT II Good Laboratory Practices: Scope, Organization, personnel- technical competence, desirable qualities of analyst, analyst validation, QBD (quality by design) responsibilities of key personnel in the QC laboratories.Routine controls, instruments, protocols, nonclinical testing, controls on animal house, data generation and storage, quality control documents, retention samples, records, audits of quality control facilities, raw data maintenance. Complaints and Recalls: Evaluation of complaints, recall procedures, related records and documents, handling of OOS (out of specification), market complaint analysis. UNIT III Documentation: Manufacturing documents, manufacturing formula, batch formula records, standard operating procedures for various operations like cleaning, filling, drying, compression, coating, disinfection, sterilization, membrane filtration etc. Unit - IV In-process Quality Control: Various dosage forms sterile, biological and non-sterile products. Packaging and labeling controls, line clearance and other packaging materials. UNIT V Environment Health and Safety (EHS): Hazards- Fire, mechanical, chemical and pharmaceutical, monitoring and prevention systems, industrial effluents testing and treatment, control of environmental pollution. Recommended books: 1. Gupta SC. Fundamentals of statistics. 6th ed., Himalaya publishing house, Hyderabad, 2004. 2. Sharma PP. How to practice GMPs, 4th ed., Vandhana publications Pvt. Ltd., Delhi, 2004. 3. Sharma PP. How to practice GLP, Vandhana publications, Delhi, 2000.

4. Quality assurance of pharmaceutical (A compendium of guidelines and selected materials) Vol. I & II, WHO, Geneva, Pharma book syndicate, Hyderabad, 2002. 5. Basic tests for pharmaceutical substances, WHO, Geneva, All India traveler book seller, India, 1990. 6. Jenkins WA, Osborne KR. Packaging drugs and pharmaceuticals. Technomic Publishing, Lancaster, 1993. PA:

7. Harburn K. Quality control of packaging materials in pharmaceutical industry. ASQC Quality Press, Milwaukee, 2005. 8. Manual on drugs and cosmetics, 2nd ed., Commercial law publishers (India) Pvt. Ltd., Delhi, 2004. 9. 10. 11. The International Pharmacopoeia, Vol. I-II, 3rd ed., WHO, Geneva, 1981. Maitra K, Ghosh SK. A Guide to total quality management. Mehra ML. Good manufacturing practices (GMP), University Book Agency.

12. Ghosh SK. ISO 9000 and total quality management. Oxford Publishing House, Calcutta. 13. Subrahmanyam.CVS, Pharmaceutical Production and Management, 2005, Vallabh Prakashan, NewDelhi.

UNIT I
Each Question Carries 10 Marks 1) What is meant by change control program? What are the challenges before change control? 2) Write an approach to effectively implement total quality management. 3) Define the term accreditation. State the objectives of national accreditation board for testing and calibration laboratories. 4) Explain the procedure for getting a quality control lab NABL accreditation. 5) Explain the Demings total quality management 14 points. 6) Explain equipment qualification. 7) Explain the terms prospective validation, retrospective validation and concurrent validation. 8) Define the term qualification and explain the importance of equipment qualification. Each Question Carries 5 Marks 1) What are the functions of a quality control system? 2) What are the responsibilities of a quality control system? 3) Explain the types of variation with an example. 4) Explain the term change control program. 5) What are the challenges faced by change control program? 6) What are the approaches to implement TQM? 7) What are the benefits and advantages of NABL accreditation? 8) Write the objectives of NABL. 9) Explain the statement create constancy of purpose for improving products and services along with an example. 10) Explain the term design qualification. 11) Explain the term installation qualification. 12) Explain the term operational qualification. 13) Explain the term performance qualification. 14) Define the term process validation. 15) Explain concurrent validation. 16) What is the necessity for performing revalidation? 17) What are the prerequisites for process validation? Each Question Carries 2 Marks 1) Define the terms quality control and quality assurance. 2) Explain the term special cause variation. 3) Explain the term common cause variation. 4) Define the term NABL. 5) Define the term accreditation.

6) Define the term qualification. 7) Define the term equipment qualification. 8) Define the term requalification. 9) Define the term process performance qualification. 10) Define the term product performance qualification. 11) Define the term prospective validation. 12) Define the term retrospective validation. 13) Define the term validation protocol. 14) Why a process should be validated?

UNIT II
Each Question Carries 10 Marks 1) Explain handling of out of specification results. 2) Explain the following a) Data generation and storage. b) Market complaint analysis.

3) Explain master formula record and batch formula record. Draw a format which can be used for preparing master formula records and batch formula records. 4) Describe the control measures to be followed towards animal house? 5) Define the term complaint? Explain, how complaints are evaluated? 6) Explain the terms adequacy audit and surveillance audit with suitable examples. Each Question Carries 5 Marks 1) Explain the responsibilities of personnel involved in quality control laboratories of sterile products. 2) Explain the term audit. Describe the auditing procedures of quality control facilities. 3) What is meant by raw data maintainance? Write the steps followed to protect the raw data. 4) Explain the criteria adopted for recalling a product from the market? 5) Write a note on GLP. 6) Write a brief note on the qualities of analysts. 7) Write a note on quality by design. 8) Explain the protocol for non-clinical laboratory. 9) Explain the effective way of handling the complaints. 10) What are the guidelines for handling complaints? 11) Write briefly the procedure for handling complaints. 12) Explain the classification of complaint recalls.

13) Write a model drug recall letter. Each Question Carries 2 Marks 1) Define the term quality by design. 2) Define the term complaint. 3) What are the types of complaints? 4) Define the term out of specification. 5) Define the term protocol. 6) Define the term raw data. 7) Define the term record. 8) Define the term data generation. 9) Define the term quality 10) What is meant by non-clinical testing?

UNIT III
Each Question Carries 10 Marks 1) What is meant by a document? List the various documents used in pharmaceutical industry? Explain any two of these. 2) Explain the term quality control documents. Who are involved in preparing and approving these documents? Describe the components in quality control documents. 3) Write the standard operating procedures employed for disinfection and sterilization operations. 4) What is meant by standard operating procedure? Describe the components involved in writing a standard operating procedure? Write a Standard Operating Procedure for cleaning. 5) Write one each standard operating procedure for compression & coating operations. 6) Write a model SOP for drying equipment. 7) Write an SOP for tablet compression. 8) Write a model SOP for dry heat sterilization. 9) Write a model SOP for disinfection. 10) Write a model SOP for membrane filtration. Each Question Carries 5 Marks 1) Explain the types of master formula records. 2) Define the term documentation, highlight its importance and explain control records. 3) Explain manufacturing formula records with a suitable example. 4) Write a note on instruction type of documents. 5) Write a note on records type of documents. 6) Write a note on manufacturing records.

7) Write a note on batch formula record. 8) Write a model SOP for cleaning of equipment. 9) Write an SOP for a capsule filling machine. 10) Write a brief note on SOP for drying. 11) Write an SOP for sterilization. Each Question Carries 2 Marks 1) Define the term document. 2) What are the different types of documents? 3) What are the general requirements for a document? 4) Define the term SOP. 5) Draw a general format for SOP. 6) Define the term disinfection. 7) Define the term sterilization. 8) Why do we need an SOP? 9) What is the need for documents in each area? 10) What are the components in an SOP?

UNIT IV
Each Question Carries 10 Marks 1) Explain briefly the in-process quality control tests for tablets. 2) Explain in-process quality control tests for capsules. 3) Describe the in-process quality control tests for ampoules. 4) Write the in-process quality control tests for sterile products. 5) Explain the quality control tests for glass containers. 6) Explain the quality control tests for biological products. 7) Explain the terms leakers test, pyrogen test and Sterility test. 8) Write the in-process quality control tests for packaging materials. 9) Write the in-process quality control tests for aerosols and suppositories. 10) Explain the in-process quality control tests for semisolid preparations. Each Question Carries 5 Marks 1) Describe the control measures to be followed for labels. 2) Describe the quality control tests for corrugated boxes. 3) Explain weight uniformity and content uniformity tests in tablets. 4) Explain the term line clearance. 5) Explain disintegration test for tablets. 6) Explain leaker test. 7) Explain powder glass test. 8) What are the stages in in-process quality control?

9) What are the types of sampling plans? 10) Write the in-process quality control tests for liquid orals. Each Question Carries 2 Marks 1) Define the term in-process quality control (IPQC). 2) Why an IPQC is required for a label? 3) Give few examples for sterile products. 4) Give few examples for biological products. 5) Define the term sterilization. 6) Define the term lyophilization. 7) Explain friability test for tablets. 8) Define the term sample. 9) What are the different equipment used during sampling process? 10) What are the different types of samples? 11) Explain the term capping. 12) Define the term Lamination. 13) Explain the terms picking, sticking and mottling. 14) Explain the term disintegration. 15) Define the term flash point. 16) What are the packaging specifications? 17) What is the objective of packaging and labeling control? 18) Why is burst test performed? 19) Explain open package test. 20) Explain closed package test.

UNIT V
Each Question Carries 10 Marks 1) Describe the primary treatment techniques used to treat waste water. 2) Classify the air pollutants with explanations. Describe the treatment measures of air pollution. 3) Write the principle involved in wet scrubbing and electrostatic precipitators with a labelled diagram. 4) Classify water pollutants. Explain any two pretreatment steps involved in treating water pollution. 5) Describe the method of estimation of dissolved oxygen and chemical oxygen demand with equations. 6) Describe effluent treatment in a formulation plant. 7) Draw neat labelled diagrams and explain cyclone separator and gravity settling chamber in air pollution treatment. 8) Explain how effluent water treatment is done in formulation plants.

9) Write a note on solid waste disposal methods. 10) Write a brief note on chemical hazards and the safety measures to be taken. Each Question Carries 5 Marks 1) Write a note on chemical hazards. 2) What are the advantages of safety management? 3) How the effluent water coming from fermentation plants is treated? 4) How the effluent water is treated in antibiotic plants? 5) What measures do you take to reduce air pollution? 6) What is the role of adsorbers and absorbers in reducing air pollutants? 7) Explain the term solid waste management. 8) Explain the role of filters in controlling air pollution. 9) Write the principle involved in chemical oxygen demand. 10) Write the principle involved in biological oxygen demand Each Question Carries 2 Marks 1) Define the term hazard. 2) Define the term industrial hazard. 3) Define the term safety. 4) What are the sources of fire hazards? 5) How to detect fire hazards? 6) Explain how sampling of water is done. 7) What are the units of BOD & COD? 8) Draw a flow chart to depict the antibiotic plant effluent treatment. 9) Define the term environment pollution. 10) Define the term pollution. 11) What are the sources of water pollution? 12) Define the term urban run off. 13) How can we remove arsenic from water? 14) How do we calculate chemical oxygen demand? 15) What are the advantages of wet scrubbers?