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. – Document control records management and archiving systems. Additional documents included each month. You must document all sampling procedures and plans in use.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

JUNE 28, 2024

Additional documents included each month. Additional documents included each month. Subscribe Different types of deviations in pharmaceuticals There are two types of deviations. If the complaints are persistent, they may reflect a fault in the manufacturing process or formulation. Additional documents included each month.

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. The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products.

Documentation 52

Documentation Dosage Labelling Data Entry 52