Quality Management System Documents A well-written document with a comprehensive and well-designed Quality Management System (QMS) can be a manager’s best friend. They are our daily guidance and instructions for our staff, the ‘go-to’ during an audit or inspection, and the first reference point when inducting new staff. But getting to a ‘good’ document like…
1. Over 70% of world drugs are produced in PIC/S GMP facilities (member countries or companies) With the US FDA joining PIC/S in 2011 and many other agencies in the queue, compliance with the PIC/S GMP regulations should be a priority for any pharmaceutical manufacturer exporting to multiple countries. I heard recently that countries where…
Electronic Quality Management Systems (eQMS) have gained increasing popularity within the healthcare industry over the last decade. The following diagram shows the various processes for which management, communication and workflows can be automated via the use of an eQMS
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. With the speed of light, the authorised document has travelled from the QA manager’s desk, was immediately processed by the…
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.
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