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.

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. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. What is deviation?

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

GMPSOP

OCTOBER 16, 2022

Master Manufacturing Instructions and Master Packaging Instructions). A process to prohibit handwritten GMP documents except for handwritten approval entries for master documents or handwritten data entries on records ; iv. A process that prohibits conflicting or redundant information among documents; iii.

Documentation 40

Documentation Data Entry Communication Packaging 40

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

JULY 31, 2023

The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. – High-Speed Tablet/Capsule Counting Machines (Critical for accurate counting and packaging of tablets and capsules). Also, it can be integrated with other external interfaces.

Documentation 52

Documentation Dosage Labelling Data Entry 52