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

Pharmaceutical Technology

JUNE 15, 2023

As clinical trials generate a massive amount of data, it can be challenging for researchers to manually review all of this data to uncover meaningful insights. For example, important information may be locked in knowledge silos or gained through experience, making it difficult to find or document.

Drug Development 52

Drug Development Compounding Adverse Reactions Dosage 52

GMPSOP

JULY 31, 2023

The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results. are functioning as expected.

Documentation 52

Documentation Dosage Labelling Data Entry 52