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…
Site Master Files and Quality Manuals: Differences 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. The confusion is understandable given that both documents appear to contain similar information. So…
Quality Management Systems (QMS), be it ISO or PIC/S, mandate that system reviews must occur. Product Quality Reviews (PQR) can provide the ideal platform not solely to fulfill a compliance requirement but to give real insight into the performance of critical QMS aspects. The premise of any QMS procss and PQQR leverage this where: Plans…
As of the 31st of January 2013, Chapter 1 will come into operation titled as “Pharmaceutical Quality System” in order to align with the concepts and terminologies described in the ICH Q10. The current version of Chapter 1 describes “Quality Management” and how it incorporates Good Manufacturing Practice (GMP). The new revision further clarifies that…
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