The European Pharmacopeia consists of a number of general and specific monographs covering various classes of products.

The monographs set out requirements to be met and followed for all products in the class.

Recently the EP has introduced a Monograph for Bovine Serum – Monograph No 04/2006:2262 to be found in E.P. 5.4

This monograph provides a definition of Bovine Serum and sets out details of production, and requirements for viral inactivation parameters, quality control testing, storage conditions and labelling.

Moregate Bovine Serum products meet these requirements and Certificates of Analysis are modeled on the QC test requirements.

The United States Pharmacopeia-National Formulary (USP-NF) contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.

Within the Pharmacopeia are Monographs and general chapters.

The monographs consist of information such as the ingredient name, definition, packaging and labelling requirements, storage and a specification.

The specifications list tests to be performed along with the procedure to be followed and the acceptable limit.

The European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London. It sits alongside the European Directorate for the Quality of Medicines (EDQM).

The main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

The EMEA publishes guidelines on quality, safety and efficacy testing requirements.

These guidelines are prepared by committees, and those guidelines which relate to the use of Bovine Serum, including Fetal Bovine Serum, in the manufacture of medicines include:

CPMP: Committee for Proprietary Medicinal Products

Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products

Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products. (Also adopted by the CVMP)

CVMP: Committee for Veterinary Medicinal Products

Requirements and Controls applied to Bovine Serum used in the production of Immunological Veterinary Medicinal products.

These Guidelines include requirements for Virus Testing of Fetal Bovine Serum and other Bovine Serum. Further reference to these requirements can be found in “Virus Testing”. 

All Moregate Biotech Fetal Bovine Serum and other Bovine Serum meet the requirements of the Guidelines in relation to Fetal Bovine Serum and Bovine Serum.

Ingredients of animal origin used in the United States of America, in the manufacture of veterinary and human biologics are required to be in compliance with the Code of Federal Regulations, Title 9 – Animals and Animal Products, Chapter 1 - Animal and Plant Health Inspection Service, Department of Agriculture Part 113-53c, commonly referred to as 9CFR Part 113-53c.

This legislation sets out the requirements for detection of extraneous viruses, detailing the methods to be used and the list of viruses that shall be tested for.  

Over time 9CFR Part 113-53c became the accepted standard for the testing of animal sera, particularly Fetal Bovine Serum for adventitious viral agents.

Bovine Respiratory Syncytical Virus, Bovine Viral Diarrhea Virus, Bovine Parvovirus, Bluetongue Virus, Bovine Adenovirus, Rabies Virus and Reovirus are tested for by fluorescent antibody

Infections Bovine Rhinotracheitis tested for by Cytopathic Agents.

Infectious Influenza 3 tested for by Haemadsorbing Agents