Biologicals

Technical Report Series: biological products: general recommendations

Guidelines on evaluation of similar Biotherapeutic Products (SBPs), ECBS, 19-23 October 2009

Biological products, use of animal cells as in vitro substrates

Title 1: Requirements for the use of animal cells as in vitro substrates for the production of biologicals; Revised 1996, TRS No 878, Annex 1
Title 2: Requirements for the use of animal cells as in vitro substrates for the production of biologicals; Addendum 2003

Biological products, regulation and licensing

Title 1: Regulation and licensing of biological products in countries with newly developing Regulatory Authorities; Adopted at ECBS 1994; Reference: TRS No 858, Annex 1
Title 2: Guidelines for national authorities on quality assurance for biological products; Adopted at ECBS 1991; Reference: TRS No 822, Annex 2

Biological products, GMP

Title 1: Good Manufacturing Practices for biological products; Adopted 1991, TRS no 822, Annex 1

Biological products, rDNA

Title: Biological Products prepared by recombinant DNA technology; Adopted 1990, TRS No 814, Annex 3

Biological products, sterility

Title: General requirements for the sterility of biological substances Revised 1973, TRS No 530, Annex 4
Amendment 1995, TRS No 872, Annex 3

Technical Report Series No. 822, 1992 Annex 3

Guidelines for assurîng the quality of monoclonal antibodies for use in humans

IMPORTANT: PUBLIC CONSULTATIONS - ECBS 2014

CLOSING DATE: 22 SEPTEMBER 2014

CLOSING DATE: 4 October 2014

New Publications

Upcoming events

Expert Committee on Biological Standardization

13-17 October 2014, Geneva, Switzerland

WHO Informal consultation on Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle (HPV-VLP) vaccines

11-12 November 2014, Geneva, Switzerland

Contacts

Quality, Safety and Standards (QSS)
Immunization, Vaccines and Biologicals (IVB)
World Health Organization (WHO)
Avenue Appia 20
1211 Geneva 27, Switzerland
Fax No. +41 22 7914971