September 12, 2021: Pharmaceutical Interview Questions and Answers

#EquipmentQualificationGuidelines

1. What are the different guidelines/ regulations describing requirement of equipment qualification?

a. EU GMP Annex 15 “Qualification and Validation”, Eudralex 2015

b. PIC/S GMP for Medicinal Products Annex 15 “Qualification and Validation” PE009-14 (Annexes) 2018

c. PE 009-15 (Annexes) ANNEX 15 – Qualification and validation

d. PI 006-3 – Validation Master Plan installation and operational qualification non-sterile process validation cleaning validation

e. Subpart C – Building and Facilities Section 211.42 – Design and Construction Features

f. USP 37: “Analytical Instrument Qualification”, (section 1058), The United States Pharmacopeial Convention, 2016

g. ISPE Baseline Guide Volume 5: “Commissioning & Qualification”, Second Edition, 2019

h. ASTM E2500: “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”, ASTM 2020

i. ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, ISPE 2011

j. PDA Technical Report 54-5: “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems”, PDA 2017

k. EU GMP Annex 11 “Computerised Systems”, Eudralex 2011

l. US FDA Guidance for Industry: “Process Validation: General Principles and Practices, 2011

m. ISPE GAMP® 5 Guide: “A Risk-Based Approach to Compliant GxP Computerized Systems”, ISPE 2008

n. ISPE Guide: “Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment”, ISPE 2011

o. FDA US CFR 21 part 11 Electronic Records; Electronic Signatures 2003

p. Health Canada: Guide to validation – drugs and supporting activities (GUI-0029)

q. WHO Technical Report Series, No. 937,  Annex 4: Supplementary guidelines on good manufacturing practices: validation

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