Since 2006, PharmOut has been a leading provider of highly regarded and coveted Quality Management Systems (QMS) template packs. Purchasing is simple and facilitated through our online shop – a simple click here, pay there, and you will be able to download a “zip file” of the QMS template of your choice, be they for…
What you need to know about PIC/S GMP Documentation Tips The TGA’s announcement of its intention to adopt PIC/S GMP PE 009-13 as of 31 December 2017 means Australian GMP manufacturers need to review their current document retention schedules and practices to maintain compliance. PharmOut’s leading PIC/S GMP consultants have studied the new guidance and…
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.
Many pharmaceutical companies struggle to close change controls. Clients often ask if the problem is caused by too many change requests and what is a reasonable number of open changes. The issue for most sites is not the number of change requests, but how old they are. Is there a problem if our site has…
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