I have always said that Cleanroom Technology is not rocket science. Although it seems the modern cleanroom was developed to assist with the progression of rocket technology. Working out of Sandia National Laboratories, Willis Whitfield, who died last month aged 92, put together the prototype of the modern cleanroom. Responding to a request by his…
Regulators from several APEC countries met in Taiwan in early November for the second workshop on Good Review Practices. This was an advanced workshop, following on from the initial meeting held in Taipei in October 2011. The workshop was jointly hosted by the Taiwanese FDA and the Center for Drug Evaluation, Chinese Taipei, and sponsored…
Annex 15 qualification and validation was originally published in September 2001, and since then there have been significant changes in the GMP environment with the incorporation of ICH Q9 and Q10. In addition, the Quality Working Party (QWP) is in the process of updating its guideline on Process Validation, and there has been advancement in…
“We have just concluded several regional training sessions with Sion Wyn on IT compliance and Computer System Validation for the drug, device and vet industries. The course curriculum was developed with industry representatives to incorporate current issues and perceived looming mega trends; providing a real world view for the next 2 years. While developing the…
Cleanrooms have been part of Life Science manufacturing for a long time, for example a device, pharmaceutical or a pharmacy clean room all have specific design requirements to make sure that they add value. As cleanrooms have evolved in parallel with the manufacturing processes and techniques themselves, it is difficult to evaluate in isolation, just…
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: Regulatory…
The debate on the number of batches used to determine if a process is validated or not has come under some scrutiny since the update of the US FDA’s Guide to Process Validation in 2011. As a result of the update, industry has tried to come up with a number of ways to help to…
Kirkpatrick 4 Levels of Learning Evaluation Model – an introduction for companies seeking to further develop their personnel. In a world where a company’s success is determined by the knowledge, attitude and work ethic of the staff within it, how do we ensure that the company can adapt, grow and succeed in this ever-changing environment?…
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