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

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