National Association of Boards of Pharmacy

APRIL 10, 2024

Read part 1 for more information on preparing for an on-site visit by a third-party organization or regulatory agency for an inspection, survey, or review of your operations. Browse our accreditations page to find information on accreditations we provide to pharmacies , online businesses , and distributors.

Drug Utilization Review 45

Drug Utilization Review Data Entry Patient Counseling Labelling 45

GMPSOP

OCTOBER 16, 2022

Master Manufacturing Instructions and Master Packaging Instructions). Memos to File shall only be used if there is not an approved document that is designed to provide the required information. Documentation standards and SOPs for Handwritten Entries on GMP records shall be established and maintained at each GMP site.

Documentation 40

Documentation Data Entry Communication Packaging 40

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

Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. Unplanned deviations Unplanned deviations may occur at any manufacturing stage, such as dispensing, processing, testing, packaging, holding, or storage. incorrect data entry).

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. While GAMP 2 systems are not directly involved in pharmaceutical processes, they may handle data that needs to be validated. Also, it can be integrated with other external interfaces.

Documentation 52

Documentation Dosage Labelling Data Entry 52

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 40

Documentation Method Validation Packaging Data Entry 40