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.

Method Validation 98

Method Validation Documentation 98

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

Documentation 98

Documentation Method Validation Packaging Labelling 98

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.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

Pharma Pathway

JANUARY 3, 2023

Micro Labs Limited-Walk-In Interview for Multiple Positions On 7th Jan’ 2023. Walk-In Interview for Multiple Positions On 7th Jan’ 2023 @ Micro Labs Limited. Skill Set: Microbiology Analytical Activities, Reviewer, QMS documentation and Environmental Monitoring in Sterile manufacturing facility. Job Description.

Method Validation 52

Method Validation Documentation 52

Pharma Pathway

JANUARY 30, 2023

Documents To Be Carried: Candidates are requested to carry updated resume, photocopies of educational certificates, and photocopy of Aadhar card and PAN Card copy. Time and Venue Details: Walk-Ins On 4th Feb’ 2023 from 9:00 AM to 1:00 PM Interview Venue and Work Location: Maithri Drugs Pvt. Maithri Drugs Pvt.

Method Validation 52

Method Validation Documentation 52

GMPSOP

SEPTEMBER 27, 2023

Cleaning validation protocol for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP Cleaning validation protocol for pharmaceutical industry Last Updated on September 28, 2023 by Kazi Prev PREVIOUS POST Table of Contents What is cleaning validation in pharmaceutical industry?

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

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.

Documentation 52

Documentation Method Validation Packaging Data Entry 52