PSC Biotech 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

Documents:

 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

• Sterile Drug Products Produced by Aseptic Process: GMP's

 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)
• 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

• FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products