Regulatory Affairs Network - FarmavitaR - Regulatory affairs network

Regulatory Affairs Network

This section is about qualtiy assurance and GMP issues

Understanding USP 71 Sterility Tests and Extended BUD

Wednesday, 25 August 2010 09:31 Zdravko Mauko QA and GMP - GMP/GLP/GCP/GDP

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.

Click here for recorded webinar.

Management Practice

Saturday, 03 March 2007 15:03 Sanjay J Daharwal QA and GMP - GMP/GLP/GCP/GDP

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Management Principles of ISO in Business Continuity Management

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.

API Audit

Tuesday, 14 November 2006 00:51 QA and GMP - GMP/GLP/GCP/GDP

Requirement for GMP audit of API manufacturer by MAH

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.