B.Pharma Important Question

BP-606T,

Quality Assurance,  

VI Sem, RGPV, B.Pharmacy

Unit I

Q.1 Write the principles and procedures for NABL accreditation. (RGPV May 2024)

Q.2 What is quality by design concept? State its elements and tools. Discuss Total Quality Management. (RGPV May 2024)

Q.4 Explain (RGPV May 2024)

a) QSEM

b) Validation

Q.5 Write in detail about the overview, elements steps for registration and benefits of ISO 9000. (RGPV Nov 2023)

Q.6 State the procedure for handling and evaluation of complaints as per GMP norms. Explain Quality Audit. (RGPV Nov 2023)

Q.7 Explain: (RGPV Nov 2023)

a) NABL

b) Calibration

Q.8 What is quality by design concept? Discuss its elements and tools. Describe the principle of NABL accreditation. (RGPV May 2022)

Unit II

Q.1 Write notes on (any two): (RGPV May 2024)

a) Construction and plant Layout

b) Control of Contamination

c) Equipment Selection

Q.2 Write notes on (any two): (RGPV Nov 2023)

a) Personnel responsibilities

b) Purchase Specifications

c) Utilities and maintenance of sterile areas

Unit III

Q.1 Describe quality control tests for containers, rubber closures and secondary packaging materials. (RGPV May 2024)

Q.2 State the importance of Protocol for the conduct of Non Clinical Laboratory study. Also write a note on importance of records and reports with reference to GLP. (RGPV May 2024)

Q.3 Write a detailed note on principles of GLP with special emphasis on Organisation and Personnel, Facilities and Equipments. (RGPV Nov 2023)

Q.4 What is ICH? Write a brief overview of QSEM guidelines. Explain stability study guideline. (RGPV May 2022)

Unit IV

Q.1 State the procedure for recalling of Goods and handling of returned Goods along with waste disposal. (RGPV May 2024)

Q.2 Write notes on: (RGPV Nov 2023)

a) Batch Formula Record

b) SOP

Q.3 Explain the following: (RGPV May 2022)

a) Quality Audit

Q.4 Enlist various components of Master formulation record. How a batch formula record is different than Master formulation record. (RGPV May 2022)

Q.5 Write short notes on any two of the following: (RGPV May 2022)

a) QA and QC

b) SOP

c) Master Formula record

Unit V

Q.1 Explain method of qualification of UV-Visible Spectrophotometer and general principles of analytical method validation. (RGPV May 2024)

Q.2 Explain the general principles of analytical method validation and add a note on calibration of pH meter. (RGPV Nov 2023)

Q.3 Write in detail about Material Management and Good Warehousing practices. (RGPV Nov 2023)

Q.4 What is good warehousing practices? Describe briefly material management in a warehouse. (RGPV May 2022)

Q.5 What is the scope and importance of validation? What arevarious parameters of analytical method validation? (RGPV May 2022)

Q.6 Explain the following: (RGPV May 2022)

a) Calibration of pH meter

Q.7 Compare qualification, calibration and validation. How do you calibrate a pH meter? (RGPV May 2022)

— Best of Luck for Exam —