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 …
What you need to know about PIC/S GMP Documentation
The TGA’s announcement of its intention to adopt PIC/S GMP PE 009-13 as of 31 December this year means Australian GMP manufacturers need to review their …
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 …
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 …
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 …
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.
The other day I was informed by a client that no-one on their site reads procedures and the only function SOPs performed was ticking a compliance check-box. In my experience this says more about …
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 …
I am often asked by new Australian-based manufacturers seeking a TGA manufacturing license and implementing a Quality Management System (QMS) what the difference is between a Site Master File (SMF) and a Quality Manual. …
