European Pharmaceutical Review
JANUARY 26, 2023
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.
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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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.
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)?
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).
Pharma Pathway
DECEMBER 31, 2022
Preparation of STP/ SOP/ DRS for QC Documentation. Involved in Analytical method Validation. Location: Ahmedabad. Role & Responsibilities: Responsible for IPQC, DS, DP and Stability sample testing on routine basis. Instruments and Equipment handling for routine use as well as calibration and qualification.
GMPSOP
OCTOBER 26, 2022
Table of Contents What is the concept of validation in pharmaceutical industry? ” Validation is a critical concept in the pharmaceutical industry. .” ” Validation is a critical concept in the pharmaceutical industry. Additional documents included each month. All written and updated by GMP experts.
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