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
