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.
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.
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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.
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.
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.
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