Good Manufacturing Practice (GMP) Archives

Blogs on Good Manufacturing Practice (GMP), the regulatory requirements for the import and manufacturing of medicinal products.

Why is Quality so Important in Vaccine Production?

Why 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, 2023

Good Manufacturing Practice (GMP)

Ten Golden Rules of GMP

What 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, 2022

Qualification of Aseptic Operators in GMP Environments

Good Manufacturing Practice (GMP)

Qualification of Aseptic Operators in GMP Environments

Working 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, 2022

Foolproof Batch Records – Quality Culture Approach

Good Manufacturing Practice (GMP)

Foolproof Batch Records – Quality Culture Approach

A 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, 2022

Foolproof Batch Records – the Process Approach

Good Manufacturing Practice (GMP)

Foolproof Batch Records – the Process Approach

Properly 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, 2022

Good Manufacturing Practice (GMP)

Foolproof Batch Records – Introduction

It’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, 2022