Self Inspection & Batch Review
- WHO TRS 961, Annex 2, GMP
- EUGMP Chapter 9 and Chapter 4
- PIC/S PE 009-15
- USFDA 21 CFR Part 211 and 211.192
- ICH Q7, Q9 and Q10
Risk Management
- ICH Q9
- WHO TRS No. 981, Annex-2
- EU GMP Annex 20
- PIC/S PE-009-15
- ISO 31000
- MHRA Data Integrity guidance
Deviation Handling
- ICH Q10
- WHO TRS 961, Annex-2
- 21 CFR 211.192
- EU GMP Chapter 8
- PIC/S PE 009-15
- ISO 9001 – QMS
Change Control
- ICH Q10
- WHO TRS No. 992, 2015 Annex 3, GMP
- EU GMP Chapter 1
- USFDA CFR 21 part 211.100
- PIC/S PE 009-15: GMP guide
- ISO 9001:QMS
Out of Specification (OOS)
- USFDA 2022
- WHO TRS 996, Annex 3
- EMA: EudraLex Volume 4
- PIC/S PE 009- 15
- ICH Q10
- MHRA
Corrective and Preventive Action (CAPA)
- ICH Q10
- 21 CFR Part 820.100
- ISO 9001:2015 – QMS
- GAMP 5 for automated systems
Process Validation
- FDA Guidelines 2011
- EU GMP, Annex 15
- PIC/S PI 006-3, 2007
- WHO Annex 3
Cleaning Validation
- APIC 2021
- PDA TR No. 29-2012
- ISPE 2020
- USFDA
Data Integrity
- USFDA GMP 2018
- MHRA 2015
- WHO 2015
- PIC/S 1-2016
Stability Studies
- ICH Guidelines: Q1A to Q1E
- USP general chapter <1150>
- EMA Stability guideline
- ASEAN guidelines
- GCC stability guidelines for (For Gulf countries)
- PIC/S stability guideline
GMP
- ICH Q7
- WHO GMP GUIDE
- USFDA 21 CFR PART 211
- EudraLex – Volume 4
- PICS GMP Guide
Pharmaceutical Quality System
- ICH Q10
- EU GMP – EudraLex volume 4
Pharmaceutical Development
- ICH Q8
- ICH Q11 for drug substances
- ICH M4Q
Good Storage and Distribution Practices (GSDP)
- WHO TRS 1025, Annex 7
- EU – EudraLex Volume 4, Part 1, Chapter 9
Electronic documents and records
- 21 CFR PART 11
- EU ANNEX 11
- WHO Data integrity guidelines
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