Range of requirements for written procedures

Throughout the WHO GMP Guidelines, in addition to sections on document requirements, many references are made to the need for written procedures for specific aspects of the manufacturing process. There is a broad range of SOPs needed for a pharmaceutical manufacturing establishment. GMP Guidelines and Regulations for pharmaceuticals, sterile products, and biologicals from WHO, the EU and several other countries make reference to ‘written procedures” throughout the documents.

In Appendix 2 of this Guide, a list of the titles of the SOPs from three vaccine manufacturers is presented to give an idea of the SOPs needed by a manufacturer.A review of WHO’s GMP Requirements for reference to "written procedures" resulted in a long list of operations and activities which must follow written approved procedures. The list covered the requirements for all aspects of the control of quality raw materials and packaging materials, the premises, the equipment, the test procedures, the production, personnel performance, and quality assurance. Appendix 1 of this Guide lists a range of the types of procedures which should be prepared in written format. Others may be required depending on the products manufactured, on the size of operations, and on the management structure of the company.