What is ISO 14644? ISO 14644 is a set of international standards developed by the International Organization for Standardization (ISO) […]
Difference between: cGMP & GMP
What is GMP?GMP (Good Manufacturing Practices) incorporates all parts of the medication manufacturing process, similar to cGMP, in order to […]
Effective Spillage Management in Pharmaceutical Production Area
Spillages can be disastrous, compromising both product quality and safety. Today, we delve into the strategies and solutions for effective […]
Detailed Steps to Start A Pharma factory ( formulation /API)
Starting a pharmaceutical factory is a complex process that involves several steps. Given your background as a chemical engineer and your experience in the pharmaceutical industry, here are the detailed steps to consider when starting a pharma factory from scratch
What is an FDA 483 ?
A 483 observation is a notification of inspectional observations issued by the U.S. Food and Drug Administration (FDA) to a […]
What is ISO 14644 ?
ISO 14644 is a series of international standards that provides guidelines for the classification of air cleanliness in cleanrooms and […]
Good Manufacturing Practices in Pharma ( GMP )
importance of Good Manufacturing Practices (GMP) for pharmaceutical facilities, including the establishment of a quality management system, appropriate facilities and equipment, documentation, employee training, and ongoing auditing and inspections. Adhering to GMPs ensures that pharmaceutical products are safe and effective for patients.
Why is cleaning validation important in pharmaceutical manufacturing?
Pharmaceutical manufacturing is a procedure that demands a high level of cleanliness and accuracy to assure the product’s safety. Clean […]
What is 21 CFR Part 11? and why do you need to know more about it?
Most of the pharma professionals would, at some point in time, have heard about the term 21 CFR part 11 […]