FDA
Change Control in Pharma, Classification: What it is?
Change control is Managing to control a change in a process/procedure/system through proper and scientific justification, review, approval, implementation, follow-up,… Read More
WHO-GMP Document Check List for Visitors
Before beginning an on-site audit: Make a plan.Review previous audits and note any potential problem areas or items flagged for… Read More
What is GMP | cGMP | GMP Principle
Good manufacturing practice and current good manufacturing practice are both terms correlated with each other. Both GMP and cGMP same… Read More
Pharmaceutical Sampling, types, tools ( Guidelines)
Pharmaceutical Sampling is the involvement of the task designed to select some part of a product for a decided purpose. The Sample is… Read More
Good Documentation Practice (GDP) in pharmaceuticals
Documentation is the cornerstone of any company's Quality Management System and is an essential GMP requirement. Good Documentation Practice is critical that… Read More
GxP in Pharmaceuticals industries (FDA guidelines)
GxP in pharmaceuticals stands for Good Practice; it ensures the quality and effectiveness of products for drugs, food, medical equipment,… Read More
Drug master file (DMF): FDA Guidelines
A Drug master file is a submission to the Food and Drug Administration (FDA) which provide confidential detailed information about… Read More
ALCOA to ALCOA Plus and Data integrity
Data integrity is a key approach in the pharmaceutical quality control system. ALCOA is (Attributable, Legible, Contemporaneous, Original, and Accurate)… Read More
Serialization in pharmaceutical
Serialization in pharmaceuticals playing a vital role in securing product information, counterfeit and falsified medicine that cause world public health… Read More