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This is an evident fact that for any industry to grow, it has to constantly improve its processes and quality parameters. This becomes more important in case of highly regulated and constantly advancing industries such as pharmaceutical industry. There…
In the previous article entitled Critical Process Parameters (CPP) – What’s the Buzz, we had built an understanding regarding Critical Process Parameters and how their identification and selection is based on Critical Quality Attributes (CQAs) among many other factors. Any…
Pharmaceutical manufacturing is an arduous task. With so many regulations, GMP’s, Quality Concerns, newer products, newer diseases, newer challenges coming up every now and then, it is really required that the professionals involved shall be performing the tasks with utmost…
There is a popular phrase that says “Mistakes are bound to happen”, so do the non-conformances in the pharmaceutical manufacturing. Even if you have validated processes, qualified vendors, qualified equipment, calibrated instruments, in-process checks, SOPs etc. in place, possibility of…
One of the basic expectations of Quality Management System is to carry out Self Inspection to assess the level of compliance. Carrying out Self Inspection is mandated by almost all the regulators in the world be it USFDA, EU,…