Address
1st & 2nd Floor 2 West Street, Ware, Hertfordshire, England, SG12 9EE
Blogs
MHRA blog
Return to International GMP Inspections – MHRA Inspectorate (blog.gov.uk)
The Lachman Blog
Blog – Lachman Consultant Services, Inc.
International Pharmaceutical Quality
IPQ.org
GEN Webinar series
On Demand Webinars – GEN – Genetic Engineering and Biotechnology News (genengnews.com)
Deficiencies and warning letters
FDA warning letters
Warning Letters | FDA
FDA Form 483
ORA FOIA Electronic Reading Room | FDA
EMA Q&As
Quality of medicines questions and answers: Part 1 | European Medicines Agency (europa.eu)
Quality of medicines questions and answers: Part 2 | European Medicines Agency (europa.eu)
Inspection reports
WHO inspection reports
WHO Public Inspection Reports (WHOPIRs) | WHO – Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
WHO Checklists
Health products policy and standards (who.int)
GMP Quick Links
EU and UK
EudraLex – Volume 4 (europa.eu)
USA USFDA
CFR – Code of Federal Regulations Title 21 (fda.gov)
Australia TGA
Good manufacturing practice (GMP) | Therapeutic Goods Administration (TGA)
Health Canada
Good manufacturing practices guide for drug products (GUI-0001) – Summary – Canada.ca
World Health Organisation
Health products policy and standards (who.int) / Health products policy and standards (who.int)
Brazil ANVISA
Regulation of companies – Anvisa
MHRA blog
Return to International GMP Inspections – MHRA Inspectorate (blog.gov.uk) (just one example)
FDA warning letters
Warning Letters | FDA
FDA Form 483
ORA FOIA Electronic Reading Room | FDA
EMA Q&As
Quality of medicines questions and answers: Part 1 | European Medicines Agency (europa.eu)
Quality of medicines questions and answers: Part 2 | European Medicines Agency (europa.eu)