GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. Dealing with out-of-specification results Laboratory result out-of-specification events are a common occurrence in the quality control process. Checkout sample preview s.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

JUNE 28, 2024

Deviations are unusual or unexplained events that can potentially impact product quality, system integrity, or personal safety. The fundamental difference between a planned and unplanned deviation is that the planned deviation is raised intentionally to improve a system, while the unplanned deviations are unexpected events or incidents.

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

GMPSOP

JULY 31, 2023

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.

Documentation 52

Documentation Dosage Labelling Data Entry 52