0Good Manufacturing Practice (GMP)Knowledge BaseQuality OriginsThe origins of robust pharmaceutical quality: Contaminated Infusion FluidsA blog on the origins of robust pharmaceutical quality, this blog focuses on the Report of the Committee appointed to inquire into the circumstances, including the production, which led to the use of contaminated infusion fluids in the Devonport Section... April 24, 2023Read more
0Good Manufacturing Practice (GMP)Knowledge BaseWhy is Quality so Important in Vaccine Production?The pharmaceutical industry plays a critical role in improving public health by developing and manufacturing drugs and vaccines. One of the key aspects of pharmaceutical production is ensuring high-quality standards to ensure the safety and efficacy of these products. In... February 28, 2023Read 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
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
0Good Manufacturing Practice (GMP)The difference between ALCOA and ALCOA+ (plus)Explore the difference between ALCOA and ALCOA+, an abbreviation used extensively in the pharmaceutical industry. July 6, 2022Read more