New EMA Guideline on Starting Materials from Biological Medicinal Products

A new EMA Guideline clarifies the most important questions about the definition of starting materials and intermediates of biological medicinal products as well as the quality documentation of the marketing authorisation dossier. More details here.


Draft Guideline ICH Q3D for Elemental Impurities published!

The ICH Q3D Guideline on Elemental Impurities has just been published. This Guideline will have a major impact on both the pharmaceutical and the API industry and companies now have  to make efforts to be prepared for the new provisions of the guideline. More details here.


Denying, Delaying, And Refusing: How to Fail a FDA Inspection

The FDA has published a new Draft Guidance on "Limiting an inspection" for comment. The document provides a detailed presentation of behaviours during a FDA inspection which may be seen as obstruction by the FDA inspectors. More details here.


CDSCO publishes more than 200 Written Confirmations for APIs from India

Written Confirmations for pharmaceutical APIs from India to be exported to the EU have been made publicly available by the CDSCO. Read more here.


Cross Contamination: Helpful Information for the Calculation of ADE/PDE Values

In practice, the conversion to PDE/ADE-based limits (e.g. in cleaning validation) leads to many issues. The new scientifically-based approach requires toxicological/ pharmacological data i.e. to precisely determine the necessary correction factors. The following documents and databases may be helpful.


Guideline on Labelling and Package Leaflet of Centrally Authorised Medicinal Products Updated

The Commission Guideline on package leaflet of centrally authorised medicinal products has been revised. Read more details here.


Variations: Important Changes in the New Application Form

As of 4 August 2013 on, a new form for variation applications has to be used. Read more here about what the marketing authorisation holder has to take into consideration.


New Requirements of the FDA on Stability Testing of Generic Drugs

The stability data required in an application for the authorisation of a generic medicinal product for the American market have been redefined in a new FDA Guideline. Read more here.


Classification of Dosage Forms according to the USP

The USP divides the pharmaceutical dosage forms into 5 groups and wants to elaborate new General Chapters to depict the quality and performance requirements specific to each of these 5 dosage forms. The current status of implementation is addressed in an interesting article of the Pharmacopeial Forum. Read more.


New EMA Inspection Requirements on Good Distribution Practices (GDP)

On 27 June 2013, the EU Commission updated the so-called "Compilation of Community Procedures on Inspections and Exchange of Information". This document serves the exchange of information and the harmonisation of inspection standards between all the EU Member States. Read more details here.


Written Confirmation: A Questions & Answer Document of the Danish Authority provides further Clarifications

The regulation regarding the imports of APIs into the EU which must be accompanied by a Written Confirmation has been effective since 2 July 2013 and keeps on raising new specific questions. The DHMA (Danish Health and Medicines Authority) has recently published a Questions & Answers document. Read more here.


FDA publishes ICH Q4B - Annex 13 on Density of Powders

The ICH Guideline on Density of Powders has now been published by the FDA and has thus come into force in the USA. Read more in the News about the possible restrictions of the FDA.


Capping, Sticking & Weight Variations - tableting problems

Many manufacturing plants face problems during tableting. The most common problems are sticking, lamination or weight variations. But what are the reasons for this? Read more.


New FDA Guideline on Quality of Heparin

In its final Guideline on Monitoring Crude Heparin for Quality, the FDA sets the FDA quality standards to be considered when using crude heparin. In particular, it must be ensured that heparin isn't contaminated with OSCS and that the correct species origin is used for the extraction of crude heparin. Read more here in the News.


How do I apply for a CEP? An updated guideline of the EDQM provides information

In an updated guideline for CEP applicants, the EDQM describes in what form they have to submit the documents to apply for a certificate of suitability. Learn more about this guideline and the application procedure here.


Risk-based Approach to APIs Consignments without Written Confirmation

API consignments without Written Confirmation which are trapped on the EU external borders and held under quarantine - how to handle this situation? A guideline of the HMA provides the answer. Read more here.


How much GMP must be reflected in the Dossier?

The European Medicines Agency EMA has published a Concept Paper underlining all aspects of manufacture that are important for both applicant and regulator. Read more.


CEPs are becoming more transparent!

Starting on 15 July 2013 there will be new regulations applying with regard to the information content of Certificates of Suitability (CEPs). Learn more about what exactly will change.


EMA updates Q&A Document on Procedures Issues for Holders of a Centralised Marketing Authorisation

The Questions and Answers of the EMA on procedural questions for centralised marketing authorisations have been recently updated and completed with 2 new questions/answers. More details here.


Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

Related to changes to an approved application of human blood and blood components intended for transfusion or further manufacture, the FDA published a draft guidance for comment. Read more here.


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