This guidance document has been prepared to aid vaccine manufacturers in the preparation and performance of the validation studies required by Good Manufacturing Practices (GMP) of the World Health Organization (WHO). The WHO GMP publications, other GMP Regulations/Guidelines and many publications on the concept and process of validation for pharmaceutical manufacture were consulted
during preparation of the Guide. These references are listed in Appendix 3. The emphasis in this guide is on WHO requirements for validation.
The whole 99 pages article is available for download at Downloads section of FarmavitaR+.
One of the most frequently asked questions recently asks how to extend the Beyond-Use Date (BUD) of compounded sterile preparations (CSPs). Eric S. Kastango, RPh, MBA, FASHP, reviewed the requirements of USP Chapter 797 necessary to complete in order to extend BUD. The use and limitation of sterility tests according to USP 71 was reviewed, along with process verification.
There are many risks that may threaten any organization by disrupting its business processes. The spectrum of risks and threats may start as a leakage in the supply pipe and may also extend to cyber crime and terrorism. Business Continuity Management serves as an ongoing process, submerged in the basic management principles of an organization including disaster recovery, business recovery, business resumptions and contingency planning.
The implementation of EU directives 2004/27/EC and 2004/28/EC makes the requirement for marketing authorisation holder (MAH) to ensure that their Active Pharmaceutical Ingredients (API) have been manufactured to GMP.