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)

Contact us if you have any questions.

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