GMPSOP

JUNE 28, 2024

It is important to understand that everyone in the pharmaceutical manufacturing facility is responsible for reporting a deviation as soon as one is identified. incorrect data entry). Example: An incorrectly spelled product name on the manufacturing instructions can be classified as a minor deviation.

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

GMPSOP

OCTOBER 28, 2023

. – Record or capture all generated raw data directly, promptly, and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial data entries on the day of entry. Pharmaceutical manufacturers must integrate the key functions of the quality control process.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

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