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The quality documents pharmaceutical manufacturing runs on, readable in full

22 regulations and guidelines from two issuing bodies plus one PLS technical review — FDA 21 CFR parts and guidance, and the ICH Q-series. Each document is parsed to searchable text with its section map, length and reading time, so you can find the clause you need before opening the official source. ISO and ISPE standards are paid publications and are not reproduced here — see iso.org and ispe.org for the official text.

22DocumentsFull text, searchable
3Issuing bodiesFDA, ICH, PLS Academic Review
188kWords indexedAcross every document
29 Jun 2026Last document addedIndex rebuilt 27 Oct 2026, 18:34
Browse by body All 22 FDA 15 ICH 6 PLS Academic Review 1
Text is machine-parsed from each publisher's document. Titles, section counts and lengths are read from the text itself, not written by us. The issuing body's PDF is the authoritative version. Index rebuilt 27 Oct 2026, 18:34 UTC
6 of 22 documents from ICH Sorted by issuing body, then document number
Body
Document
Sections
Reading
ICH
ICH Q10 Pharmaceutical Quality System: Guideline for Pharmaceutical Quality System
ICH-Q10-Complete · Harmonised quality guidelines · 5,376 words · added 11 Jun 2026
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23 min
Read document →
ICH
ICH Harmonised Guideline Q12 (2019): Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
ICH-Q12-Complete · Harmonised quality guidelines · 9,314 words · added 11 Jun 2026
3
40 min
Read document →
ICH
ICH Harmonised Guideline Q13 (2022): Continuous Manufacturing of Drug Substances and Drug Products
ICH-Q13-Complete · Harmonised quality guidelines · 14,571 words · added 11 Jun 2026
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63 min
Read document →
ICH
ICH Harmonised Guideline Q14 (2023): Analytical Procedure Development
ICH-Q14-Complete · Harmonised quality guidelines · 13,737 words · added 11 Jun 2026
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60 min
Read document →
ICH
ICH Q8(R2) Pharmaceutical Development: Pharmaceutical Development Guideline
ICH-Q8R2-Complete · Harmonised quality guidelines · 8,122 words · added 11 Jun 2026
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35 min
Read document →
ICH
ICH Q9(R1) Quality Risk Management: Quality Risk Management Guideline
ICH-Q9R1-Complete · Harmonised quality guidelines · 9,532 words · added 11 Jun 2026
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41 min
Read document →
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Issuing bodies and how to get the official text

FDA U.S. Food and Drug Administration · 15 documents Regulations and guidance for industry. Public domain. Official publications →
ICH International Council for Harmonisation · 6 documents Harmonised quality guidelines. Freely published by ICH. Official publications →
PLS Academic Review Priya Life Science · 1 document Technical review by Sreepriya Prasannan (AI-assisted, human-reviewed). Published by Priya Life Science. Official publications →