Last week, my colleague Kate Wild wrote an interesting blog on GMP SOP writing, and it prompted me to think about how we write, review, approve and execute qualification and validation protocols, so all …
What is an SOP Effective date?
It is surprising how often we review a Standard Operating Procedure (SOP) for a client and the SOP effective date is the same date that QA approved the procedure.
This White Paper explores the methods of preventing contamination and cross-contamination in manufacturing facilities.
To identify potential contributors of contamination and cross contamination.
To offer ideas on how to minimise and prevent contamination and …
Validating an autoclave
Validating an autoclave is a daunting and time-consuming task.
This white paper details the tricks, tips and traps to such a validation project from how to choose your control to which load configuration …
A New Year a New GMP quiz!
You’ve probably already done the old quiz, so test your updated GMP knowledge with the latest PharmOut 2016 GMP quiz.
All new questions have been developed as well and a …
Often, companies find themselves inundated with open CAPAs. This is most commonly experienced in the aftermath of an audit, where the CAPA system is used to document the issues that are identified, the investigations, the execution of corrective and/or preventative actions, and finally the closures.
This White Paper reviews the proposed changes to Annex 15 of the EU GMP guide in detail. The draft of the revised Annex 15 was released in February 2014 by the European Commission. The …
You have a great idea to save water and energy in the facility. The engineering changes required for capturing savings are straightforward, but if the changes will impact a GMP system, the effort becomes more complex and may have a large financial impact.
March 1st 2014 will see the newest revision of the PIC/S GMP Guide (PE 009-11) come into effect, replacing the previous version PE 009-10 that has been current since January 2013.
This paper reviews the principles of risk management in software development of GxP systems, elaborates on the well-known risk management approaches and identifies some of the important concepts of proactive management of risks throughout the software development lifecycle.