Resource library
Pharmaceutical Resources
Pharmaceutical resources for approved masters, executed batch records, material status, signatures, packaging reconciliation and accountable disposition.
- Guides
- 3 guides
- Glossary
- 2 glossary entries
- Checklist
- 9 buyer questions
US Drug CGMP Reference
Part 210 sets the status, applicability and definitions for US drug CGMP. Part 211 holds the detailed rules for preparing finished drug products for humans or animals, excluding PET drugs and medical gases as defined in § 213.3(b)(12). Supplements, PET drugs and APIs are covered separately. Your regulatory team decides what applies.
Guide21 CFR Part 211 Drug CGMP — the control chainScope, quality unit authority, component lot acceptance, masters versus executed records, laboratory conformity and record review, with a checkable worked example.Read the guide
GuideGMP Manufacturing Readiness — Walk One BatchFollow one fictional tablet batch through yield, labeling reconciliation, investigation scope, disposition, a later complaint and return, annual evaluation and a timed retrieval drill.Open
Glossary21 CFR Part 210 — scope and definitionsWhat Part 210 covers, its exact applicability statements and the defined terms used throughout Part 211.Open- ReferenceOfficial text: 21 CFR Part 211 (eCFR)The current official regulation text, for your own regulatory reading.Read the reference
Contract Manufacturing
When another company manufactures, tests or packs for you, the owner's quality unit still approves or rejects the product. A written quality agreement records who does what; it does not move CGMP duties.
GuideCMO and CDMO Quality Systems — Owner and Contractor HandoffsScoping responsibilities, selection evidence, records access, cross-boundary investigations, change and subcontract control, with a fictional one-lot handoff exercise.Read the guide
GlossaryQuality AgreementWhat a drug quality agreement records, what it cannot transfer, and how law, FDA guidance and site practice differ.Open
Quality-Decision Reading
Keep evidence review, an authorised decision and the resulting inventory status distinct.
Software Pages
Use the existing production and review information to prepare an evaluation around your own batch records.
Evaluate the software
Work through these questions with your production and quality teams, then use them to plan an evaluation with your own records.
The existing operations guide remains email-gated. Review its scope with your quality team; printing is available in the reader. Open the existing guide offer.
Explore the workflow
The illustrated five-step workflow follows released materials, dispensing to the master record, signed execution stages, packaging reconciliation and a person recording batch disposition.
Explore the pharmaceutical workflow