Industry Links
BioTechLogic provides services that are compliant with global agencies and reflect current industry practice. Several useful industry links, including organizations and specific documents, are listed below.
Regulatory Agencies:
- FDA–U.S. Food and Drug Administration
- EMEA–European Medicines Agency
- MHRA–Medicines and Healthcare Products Regulatory Agency (U.K.)
Industry Organizations:
- BIO–Biotechnology Industry Organization
- ASQ–American Society for Quality
- ISPE–International Society for Pharmaceutical Engineering
- iBIO–Illinois Biotechnology Industry Association
- moBIO–Missouri Biotechnology Association
- NCBIO–North Carolina Biosciences Organization
- North Carolina Biotechnology Center
- MdBio
- PDA - Parenteral Drug Association
- USP - U.S. Pharmacopeia
- FDA Guides
- FDA’s Guides to Inspections
- FDA Biotechnology Inspection Guide
- FDA: Frequently Asked Questions About Therapeutic Biological Products
- FDA: Points to Consider in the Manufacture and Testing. of Monoclonal Antibody Products for Human Use
- Process Validation
- FDA Guideline On General Principles Of Process Validation
- WHO Supplementary Training Modules: Validation, Water, Air Handling Systems
- Draft Process Validation Guidance
- ICH Guidance Documents
- ICH Q7: GMP’s for API’s
- ICH Q8: Pharmaceutical Development
- ICH Q9: Quality Risk Management
- ICHQ10: Pharmaceutical Quality Systems
- All ICH Guidelines
- Sterile Products
- EMEA Manufacturing and BioTechlogy Guidelines
- EMEA Scientific Guidelines for Human Medicinal Products
- EUDRALEX: Volume 4–Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice
- Includes:
- Annex 1: Manufacture of Sterile Medicinal Products
- Annex 2: Manufacture of Biological Medicinal Products for Human Use
- Annex 8: Sampling of Starting and Packaging Materials
- Annex 11: Computerised Systems
- Annex 13: Manufacture of Investigational Medicinal Products
- Annex 14: Manufacture of Products derived from Human Blood or Human Plasma
- Annex 15: Qualification and validation (July 2001)
- Annex 16: Certification by a Qualified person and Batch Release (July 2001)
- Annex 18: Good manufacturing practice for active pharmaceutical ingredients
- Annex 19: Reference and Retention Samples (December 2005)
- Includes:
- EMEA Guidelines
- EMEA Quality Guidelines
- EMEA Biotechnology Guidelines
- Changes to Biologic
- FDA: Changes to An Approved Biologic: Human Blood and Blood Components
- FDA: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
- Comparability