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. Checkout sample preview s.

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GMPSOP

JUNE 28, 2024

Deviations are unusual or unexplained events that can potentially impact product quality, system integrity, or personal safety. The fundamental difference between a planned and unplanned deviation is that the planned deviation is raised intentionally to improve a system, while the unplanned deviations are unexpected events or incidents.

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GMPSOP

OCTOBER 16, 2022

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. Defined responsibilities for review and approval of documents at the site; v.

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GMPSOP

APRIL 19, 2024

Excel spreadsheets are widely used in pharmaceutical operations, from simple data entry in the registers to complex data processing using functions and formulas. This would involve typical day-to-day tasks, such as data entry, calculations, generating reports, or any other regular function the spreadsheet is intended for.

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GMPSOP

APRIL 3, 2023

Data management policy : This policy governs activities for data entry, storage, and retrieval to ensure the integrity of laboratory results. Record keeping policy : this policy outlines procedures for documenting laboratory activities, including data, results, and observations.

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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. – Archive records so that they are protected, secure, and easily retrievable.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

The process of actioning case reports is typically split into six stages: case receipt, triage (deciding whether a case should be classified as serious, non-serious or a non-event), data entry, quality review, medical review, and submission.

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GMPSOP

JULY 31, 2023

The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. Alarm and safety test: Acceptance Criteria: The autoclave’s alarms should activate and safety interlocks should function correctly when triggered by predefined events or conditions.

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European Pharmaceutical Review

MAY 22, 2025

2 Reassigning skilled resources : Routine tasks like data-entry and initial case processing are essential but monotonous. By leveraging AI to handle data, this risk can be mitigated, ensuring more accurate and reliable pharmacovigilance reporting and insights.

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