Blog Posts - Gmp



Good Manufacturing and Distribution Practice Inspectors Working Group

The European Medicines Agency has published a report titled “Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015”.The report provides an overview of the activities of GMP inspectors across Europe. As th...
by Pharmaceutical Microbiology on Dec 19, 2016

WHO guidance on variations to multisource pharmaceutical products

The World Health Organization has updated Annex 10 of its GMPs “WHO general guidance on variations to multisource pharmaceutical products.”According to the document:“A marketing authorization (MA) holder or applicant is responsible for the qual...
by Pharmaceutical Microbiology on Oct 20, 2016

Draft PIC/S guidance on data integrity

PIC/S has issued a new draft document relating to data integrity, titled “Good practices for data management and integrity in regulated GMP/GDP environments.” (PI 041-1 (Draft 2)).According to the document:Good data management practices influence...
by Pharmaceutical Microbiology on Sep 29, 2016

New EMA draft guideline on sterilisation of the medicinal product

Given the importance of sterile products, in providing both a therapeutic medicine and with regards to the necessity of being free from viable microorganisms, pyrogenic substances and visible particulates, no new guidance has been issued by a regulat...
by Pharmaceutical Microbiology on Sep 28, 2016

EU GMP Annex 17 ‘real time testing’

The EMA has published responses to the public consultation on EU GMP Guidelines, revised Annex 17 on the Real Time Release testing.The draft expands the concepts of ‘real time’ testing beyond just parametric release and could provide opportunitie...
by Pharmaceutical Microbiology on Sep 23, 2016

Managing Regulatory Inspections

When it comes to being prepared for an inspection from a regulatory authority, the combination of practice and preparation will often make the difference between success and failure.Pharmaceutical Manufacturing are hosting a useful article by Joachim...
by Pharmaceutical Microbiology on Jul 21, 2016

India Releases New Biosimilars Guidance

India’s Central Drugs Standard Control Organization on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India's regulators look to develop more specific guidance on postma...
by Pharmaceutical Microbiology on Jun 28, 2016

Good Distribution Practice - Qualification of suppliers

The U.K. MHRA have produced a useful article about Good Distribution Practice. The article is titled “Good Distribution Practice - Qualification of suppliers, a helpful reminder of the 3 steps needed to assure supply chain integrity.”The first st...
by Pharmaceutical Microbiology on Jun 24, 2016

Good Documentation Practice

Siegfried Schmitt has written an interesting article for BioPharm International, titled “Good Documentation Practice: Saving Data for the Long Term.”Here is an extract:“Laboratory data may be in some proprietary format depending on the instrume...
by Pharmaceutical Microbiology on Apr 7, 2016

Technical Guide for the elaboration of monographs

EDQM has released a revised technical Guide for the elaboration of monographs (7th Edition 2015)For further details see EDQM Posted by Tim SandlePharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com...
by Pharmaceutical Microbiology on Nov 22, 2015

WHO Good Data and Record Management Practices

The World Health Organization (WHO) has issued a draft guidance document titled “Good Data and Record Management Practices.” The document is out for public comment.Medicines regulatory systems worldwide have always depended upon the knowledge of...
by Pharmaceutical Microbiology on Nov 18, 2015

European Sterile Products Guidance Under Review

Annex 1 to the EU GMP Guide is under review. The annex focuses on sterile products. To consider what might be expected, Tim Sandle has written an article for American Pharmaceutical Review assessing what the new version might contain and some persona...
by Pharmaceutical Microbiology on Nov 16, 2015

Clarification for products outside the scope of the ICH Q3D Guideline

A new guidance document has been released: “Ph. Eur. Policy on Elemental Impurities: Clarification for products outside the scope of the ICH Q3D Guideline.”The European Pharmacopoeia Commission published its implementation strategy for the Intern...
by Pharmaceutical Microbiology on Oct 17, 2015

EU GMP Annex 16 - revised

EU GMP Annex 16: Certification by a Qualified Person and Batch ReleaseThe Annex has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has been carried ou...
by Pharmaceutical Microbiology on Oct 15, 2015

Revised Annex 17 on the Real Time Release Testing

Consultation has begun on EU GMP Guidelines, revised Annex 17 on the Real Time Release Testing.In terms of the scope of the document:“This document is intended to outline the requirements for application of a Real Time Release Testing (RTRT) approa...
by Pharmaceutical Microbiology on Oct 9, 2015

EU GMP Annex 15

In February 2014 the draft for the revision of Annex 15 “Qualification and Validation” was published. Now the draft has been published as final document and will be valid as of 1 October 2015. The introduction reads:“This Annex describes the pr...
by Pharmaceutical Microbiology on Sep 30, 2015

New GMP Implementing Act published

The EU Commission has published a new public consultation on an Implementing Act on GMP principles and guidelines for medicinal products for human use. The introduction to the document sets out the reasons for change:"Directive 2001/83/EC of the Euro...
by Pharmaceutical Microbiology on Sep 11, 2015

Contamination control guidances under review

Two important sets of documents, both of which shape the way control and monitoring of contamination is handled within cleanrooms, are under review. These are Annex 1 to EU GMP, which relates to the manufacture of sterile medicinal products, and...
by Pharmaceutical Microbiology on Sep 9, 2015

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH has issued a final version of its questions and answers relating to ICH Q7. According to ICH:“The Guideline reached Step 4 of the ICH process on June 2015. Experience gained with the implementation of the ICH Q7 Guideline since its finalisation...
by Pharmaceutical Microbiology on Aug 27, 2015

Guidance for importers of medicinal products

The European Medicines Agency has issued a new concept paper “Guidance for importers of medicinal products.”The paper poses and addresses the following problem statement:“The increased complexity of supply chains and the observation that most G...
by Pharmaceutical Microbiology on Aug 23, 2015


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