0Knowledge BaseLicensing in the European UnionMIA & WDLManufacturing and Import Authorization (MIA) – GMP License August 18, 2022Read more
0Good Manufacturing Practice (GMP)Ten Golden Rules of GMPWhat is GMP? The World Health Organization defines the GMP as follows; GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine... July 6, 2022Read more
0Good Manufacturing Practice (GMP)Qualification of Aseptic Operators in GMP EnvironmentsWorking in a GMP cleanroom Working in a cleanroom under GMP isn’t easy, you have your gowning to consider, your movements, your equipment and then there’s the new operator who needs continuous monitoring. Qualifying aseptic operators poses a significant challenge,... July 6, 2022Read more
0Human ErrorAvoiding The Three Common Mistakes in Solving Human ErrorsAvoiding common pitfalls For several years now our training Human Error Reduction has been a well-attended seminar. Even though human errors aren’t a new phenomena! The GMP expects you to properly investigate human failure. You might be wondering why many... July 6, 2022Read more
0Good Manufacturing Practice (GMP)Foolproof Batch Records – Quality Culture ApproachA perfect world Just imagine; You have a set of GMP Batch Records describing what needs to be done. Critical GMP actions are double checked. Operators signed off all applicable steps. Deviations from the process are clearly explained. Corrections are... July 6, 2022Read more
0Good Manufacturing Practice (GMP)Foolproof Batch Records – the Process ApproachProperly designed batch records In my experience, many companies don’t realize that to develop a batch record properly; the underlying manufacturing process should be thoroughly engineered and organized. We all know that batch records should be designed to fulfill many... July 6, 2022Read more
0Good Manufacturing Practice (GMP)Foolproof Batch Records – IntroductionIt’s one thing to write a GMP batch record, but it’s another thing to make it clear, concise, unidirectional and above all, foolproof. At PCS we perform a lot of GMP audits. Obviously, the BPR (batch processing record) is at... July 6, 2022Read more
0Human ErrorReduce Human Errors in the Pharmaceutical IndustryHumans Make Mistakes It’s a statement that is frequently heard in the pharmaceutical industry. We’re not robots, we do not have a perfect memory and tend to make our own assessments. The high percentage of deviations of which 70% is... July 6, 2022Read more