Remove Data Entry Remove Labelling Remove Pharmaceutical Manufacturing
article thumbnail

Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

Adulterated Pharmaceuticals: 396 warnings iii. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. incorrect data entry). CGMP Deviation: 39 warnings ii. Adulterated API: 39 warnings iv.

article thumbnail

What are the elements of quality control process in pharmaceuticals

GMPSOP

Typical flow of samples in a quality control laboratory The quality control laboratory receives samples that are collected randomly at the beginning, middle, and end of manufacturing processes. . – Record or capture all generated raw data directly, promptly, and legibly. Typical documentation in a quality control process?

article thumbnail

How to perform operational qualification – step by step

GMPSOP

The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. Pharmaceutical manufacturing operations typically maintain equipment varying from simple balances and scales to complex automated process control and monitoring systems.