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
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