EMA

• Guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products (2008)

EP*

• EP 2.6.1 - Sterility

• EP 2.6.8 - Pyrogens

• EP 2.6.9 - Abnormal Toxicity

• EP 2.6.12 - Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests

• EP 2.6.14 - Bacterial Endotoxins

• EP 2.6.16 - Tests for Extraneous Agent in Viral Vaccines for Human Use

• EP 5.1.3 - Efficacy of Antimicrobial Preservation

• EP 5.2.3 - Cell Substrates for the Production of Vaccines for Human Use

• EP 2.7.2 - Microbiological Assay of Antibiotics

*These documents are available for purchase through the EDQM Website.

• ISO 11737-1 - Sterilization of Medical Devices: Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products

• ISO 11737-2 - Sterilization of Medical Devices: Microbiological Methods - Part 2: Tests of Sterility performed in the Definition, Validation and Maintenance of a Sterilization Process

*These documents are available for purchase through the The International Organization for Standardization.

FDA

• Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (1997)
  

• 1997 Points to Consider: Manufacture and Testing of Monoclonal Antibody Products for Human Use (1997) 
  

• 1995 Points to Consider: Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals (1995)

• 1985 Points To Consider: Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology (1985)
  

• Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (2007)
  

• ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (2004)
  

• Source Animal, Product, Preclinical and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans (2003)
  

• Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (2002)
  

• Draft Guidance for Industry regarding Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (2002)
  

• Revised Precautionary Measures to Reduce the Possible Risk of CJD and New Variant CJD by Blood and Blood Products (2002)
 

• M4S:  The CTD - Safety Appendices (2001)
  

• M4S:  The CTD - Safety (2001)
  

• M4E:  The CTD - Efficacy (2001)
  

• M4Q:  The CTD - Quality (2001)
  

• M4:  Organization of the Common Technical Document (2001)
  

• Letter to Sponsors on Use of Vero Cells for Investigational Vaccines (2001)
  

• Guidance for Monoclonal Antibodies Used as Reagents in Drug Manufacturing (2001)
  

• Guidance for Industry:  Pyrogen and Endotoxins Testing: Questions and Answers

• Letter to Sponsors of INDs or Master Files; Guidance for Manufacturers of Gene Therapy Products (2000)
  

USP*

• USP<51>  Antimicrobial Effectiveness Testing

• USP<61>  Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests

• USP<81> Antibiotics - Microbial Assays

• USP<85> - Bacterial Endotoxins Test

• USP<88> Biological Reactivity Tests, In vivo

• USP<111> Deisign and Analysis of Biological Assays

*These documents are available for purchase through the The United States Pharmacopeial Convention.

• E6 Guidelines for Good Clinical Practice (1996)
  
• Q5C; Quality of Biotechnological Products: Stability Testing of Biotechnology/Biological Products (1995)
  
• Q2(R1) Validation of Analytical Procedures
  
• Q6B; Specifications, Tests and Procedures for Biotechnological/Biological Products (1999)
  
• S2; Guidance on Genotoxicity Testing and Data Interpreatation for Pharmaceuticals Intended for Human Use (2011)