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EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices.

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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

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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Typical GMP documentation in a quality control laboratory

GMPSOP

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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FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

He also stressed the importance of reviewing batch records and analytical records and the need for clear documentation practices. Dr Khurana stressed the importance of risk-based testing and the need for proper documentation. He mentioned the role of quality assurance in ensuring these practices are followed.

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Micro Labs Ltd-Walk-In Interviews for Microbiology/ QC/ Production On 17th Sept’ 2022

Pharma Pathway

Skill Set: Method Validation/ Verification analysis hands HPLC/ GC/ LCMS/ ICPMS etc., Skill Set: Microbiology Analytical Activities, Reviewer, QMS documentation and Environmental Monitoring in Sterile manufacturing facility. Experience : 02 to 08 years with relevant Experience. Role & Responsibilities: . Executive/ Asst.

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Cleaning validation protocol for pharmaceutical industry

GMPSOP

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.

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Validation master plan (VMP) – when and how to create one?

GMPSOP

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)?