Guidelines hub
Every standard a QC microbiologist works with, explained simply
Which chapter governs which test, what each regulator expects, and where industry guidance helps. Written in our own words, with links to learn more and test yourself.
Pharmacopoeias
USP
US Pharmacopeial Convention
The legal standard for medicines in the US and a reference for many export markets. Its microbiology chapters are harmonised with Ph. Eur. and JP.
10 key references →
Ph. Eur.
EDQM, Council of Europe
Legally binding in member states of the European Pharmacopoeia Convention and used by many regulators worldwide.
8 key references →
IP
Indian Pharmacopoeia Commission
The official book of standards for drugs in India under the Drugs and Cosmetics Act.
4 key references →
JP
MHLW / PMDA, Japan
The official pharmacopoeia of Japan and a member of the Pharmacopoeial Discussion Group.
3 key references →
Regulations
US FDA
US Department of Health and Human Services
Regulates medicines supplied to the US through 21 CFR and guidance documents, enforced by inspections.
6 key references →
Schedule M
Ministry of Health and Family Welfare / CDSCO
India's GMP requirements, revised in December 2023 to align more closely with WHO and PIC/S.
3 key references →
Regulatory guidance
EU GMP
European Commission
The GMP rules for Europe, including Annex 1 for sterile products. PIC/S uses the same text.
5 key references →
WHO GMP
World Health Organization
GMP guidance published in WHO Technical Report Series annexes, used by many national regulators and for WHO prequalification.
3 key references →
PIC/S
PIC/S
A co-operation of GMP inspectorates. PIC/S GMP guides mirror EU GMP.
2 key references →
Industry guidance
Standards
These pages explain requirements in our own words for learning. Official texts are revised regularly: always check the current edition before relying on a limit or method. How we use references