Dr. A.P.J. Abdul Kalam University M.Pharm (Quality Assurance) II SEM Pharmaceutical Validation [MQA202T] June 2021 Question Paper

Dr. A.P.J. Abdul Kalam University

Master of Pharmacy (Quality Assurance)

Second Semester Examination, June-2021

Pharmaceutical Validation [MQA202T]

Time: 3:00 Hrs Max Marks 75

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

Q.1 (a) Explain Validation of Utility systems: Pharmaceutical water system &

pure steam

(b) Explain HVAC system and its validation

Q.2 (a) What is the main of Compressed air and nitrogen in pharma industry

(b) Write the concept of process validation.

Q.3 (a) Explain in detail the Process and documentation of Process Validation.

(b) What do you mean by prospective, Concurrent & Retrospective

Validation.

Q.4 (a) Explain the Re validation criteria, Process involved in it

(b) Write about the Validation of various formulations (Coated tablets,

Capsules, Ointment/Creams.)

Q.5 (a) Write about in brief liquid Orals and aerosols., Aseptic filling: Media fill

validation,

(b) Write short note on USFDA guidelines.

Q.6 (a) What is on Process Validation- A life cycle approach?

(b) Give analytical method validation: General principles, Validation of

analytical method as per ICH guidelines (Q2) and USP.

Q.7 (a) Explain cleaning Validation: Cleaning Method development, Validation

of analytical method used in cleaning,

(b) Write short note on following

(i) Cleaning of Equipment.

(ii) Cleaning of Facilities.

Q.8 (a) Explain in detail Cleaning in Equipment

(b) Explain the Validation of facilities in sterile and non-sterile plant

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