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Guidances

GuidancesWebsite Administrator2020-10-01T16:54:05-04:00

International

WHO: World Health Organization

Asia

  • China: SFDA, Good Manufacturing Practice for Drugs
  • China: SFDA, State Food and Drug Administration, P.R. China
  • India: Central Drugs Standard Control Organization, Directorate General of Health Service, Ministry of Health and Family Welfare, Government of India
  • India: Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products (Schedule M)

Europe

  • EC (European Commission): Enterprise DG Pharmaceuticals
  • EMA – European Medicines Agency – Homepage
  • EMA: Concept Paper on Storage Conditions during Transport
  • EMA: Concept Paper on the Revision of Chapter 6 of the EU GMP Guide Quality Control
  • EMA: Documentation Service – Contacts
  • EMA: history and description
  • EMA: news and events
  • EU-GDP-Guideline (Draft 2011)
  • EU-GMP-Guidelines
  • EU-Pharmacopeia (Ph.Eur.) – online-Version – edqm
  • WHO (World Health Organization): Regional Office for Europe
  • Bulgaria: Bulgarian Drug Agency
  • Czech Republic: State Institute for Drug Control
  • Hungary: National Institute of Pharmacy
  • Lithuania: State Medicines Control Agency
  • Romania: National Medicines Agency
  • Austria: Bundesministerium für Gesundheit, Familie und Jugend
  • Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
  • Germany: Paul-Ehrlich-Institut (PEI)
  • Germany: Robert Koch Institut
  • Germany: Zentrale Gesundheitsbehörde der Länder (ZLG)
  • Switzerland: Bundesamt für Gesundheit
  • Switzerland: Swissmedic Schweizerisches Heilmittelinstitut(früher: Interkantonale Kontrollstelle für Heilmittel (IKS))
  • Denmark: Danish Medicines Agency
  • Finland: Medicines Agency – Fimea
  • Iceland: Icelandic Medicines Agency (IMA)
  • Sweden: Medical Products Agency – Läkemedelsverket
  • Greece: Adverse Drug Reactions Section
  • Italy: Ministero della Salute
  • Malta: Medicines Regulatory Unit
  • Belgium: Federal Agency for Medicines and Health Products
  • France: Ministère de la santé
  • Ireland: Irish Medicines Board
  • UK: Medicines and Healthcare products Regulatory Agency (MHRA)

North America

  • CFR: Code of Federal Regulations Title 21
  • FDA: Counterfeit Medicine
  • FDA: Foreign Inspections
  • FDA: Glossary of Computer Systems Software Development Terminology
  • FDA: Guidance, Compliance and Regulatory Infomation (CDER)
  • FDA: Guideline for Drug Master Files
  • FDA: Homepage – U.S. Food and Drug Administration
  • FDA: Inspection Guides
  • FDA: Process Validation
  • FDA: Warning letters
  • Health Canada: Good Manufacturing Practices
  • Health Canada: Guidance Documents

Organizations Europe (EU)

  • DIA: Drug Information Association for Europe
  • EDQM: European Department for the Quality of Medicines Council of Europe
  • Eucomed: European Medical Device Industry Group
  • IPEC: The International Pharmaceutical Excipients Council Europe
  • ISPE: The International Society for Pharmaceutical Engineering
  • MHRA: Medicines and Healthcare products Regulatory Agency (GB)
  • PDA: Parenteral Drug Association – Europe
  • PIC/S: Pharmaceutical Inspection Co-operation Scheme

Organizations International

  • GHTF: Global Harmonization Task Force
  • ICH: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • IFPMA: International Federation of Pharmaceutical Manufacturers Associations
  • OECD: Organization for Economic Co-Operation and Development
  • WSMI: WORLD Self-MEDICATION INDUSTRY

Organizations USA

  • aaps: American Association of Pharmaceutical Scientists
  • APhA: American Pharmaceutical Association
  • DIA: Drug Information Association
  • ISPE: Headquarters
  • NIH: National Institutes of Health
  • PDA: Parenteral Drug Associations
  • PhRMA: Pharmaceutical Research and Manufacturers of America
  • USP: U.S. Pharmacopeial Convention

BRG Papers

  • FINDING GREAT GMP TALENT
  • HIRING THE CORE GMP TEAM
  • RPO SERVICE MAP
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