GMPSOP

DECEMBER 24, 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. This method validation package should confirm the suitability of the method.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

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. A standard name and a unique item code define packaging materials.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

JUNE 28, 2024

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.

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