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5 modules12 lessons~10 h
Pharmacopoeia & Regulatory Guidelines for QC Microbiology
USP, Ph. Eur., IP, EU GMP Annex 1, US FDA, WHO, PIC/S and PDA explained for QC microbiologists, with quizzes and a certificate.
What you'll be able to do
- ✓ Know which chapter or guideline governs each micro test and programme
- ✓ Read a pharmacopoeia correctly, including informational chapters
- ✓ Apply Annex 1 expectations to EM, APS, disinfection and personnel
- ✓ Understand 21 CFR 211 and FDA guidance themes behind warning letters
- ✓ Use PDA technical reports and ISO standards to justify designs
- ✓ Build a compliance matrix that makes audits calm
Syllabus
MODULE 1How standards workLaws, pharmacopoeias, guidance and industry references.
- How the standards fit togetherFree preview
- Reading a pharmacopoeia like an auditor
MODULE 2USP microbiology chaptersNon-sterile, sterile and informational chapters.
- Non-sterile products: <61>, <62>, <1111>
- Sterile products: <71>, <85>, <86>, <151>
- The informational chapters every lab uses
MODULE 3EU GMP, India, WHO and PIC/SAnnex 1 and the texts around it.
- EU GMP Annex 1 for the micro lab
- Chapter 6, Annex 11 and Annex 15
- India, WHO and PIC/S
MODULE 4US FDARegulations, guidance and how findings are issued.
- 21 CFR 211 and key FDA guidance
MODULE 5Industry guidance and compliancePDA, ISO and the compliance matrix.
- PDA technical reports
- ISO standards and a compliance matrix
- Final exam
Questions
Does the course copy the official texts?
No. It explains requirements in our own words and tells you which official text to read. Always check the current edition.
Is there a certificate?
Yes, after passing the final exam with 70%.