European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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GMPSOP

APRIL 3, 2023

To confirm your test results are trustworthy and unbiased, you would turn to well-designed policies, procedures, guidelines, methods, protocols and all types of records. In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab.

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GMPSOP

SEPTEMBER 27, 2023

A pharmaceutical manufacturing plant compliant with Good Manufacturing Practices must have a cleaning validation program in place to establish documented evidence that the cleaning processes will consistently meet expectations by removing the traces of residues from the earlier products. Additional documents included each month.

Method Validation 98

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GMPSOP

MAY 31, 2024

This article can help you understand who is responsible for preparing the validation master plan, the stages of the validation life cycle, the risk-based prioritization of validation items, how to prepare a validation schedule, and some practical examples. What is a validation master plan (VMP)?

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GMPSOP

JUNE 9, 2024

Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).

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Method Validation Documentation Health and Personal Care Stores Labelling 52

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. – Document control records management and archiving systems. Additional documents included each month. All written and updated by GMP experts.

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