GMP News - APIs and Excipients


Indian and Chinese API Manufacturers in the Focus of European Authorities

Within one week the Italian authority published three reports on inspections in API manufacturing sites in the Eudra GMDP database. Read more about what GMP deficiencies were found in these manufacturing sites and what consequences it will have for the relevant companies.



ICH Publishes New Question and Answer Guideline

Already in October 2012 the International Conference on Harmonisation (ICH) has started to develop the ICH Q7 Q&As. Now the ICH has published the ICH Q7 Questions and Anwers on GMP for Active Pharmaceutical Ingredients. It is the intension of the guideline to clarify uncertainties due to different interpretations of requirements laid down in the ICH Q7 Guideline. Please read more about the ICH Q7 Question and Answer Guideline published by ICH.



The new requirements of the "Guidelines on the formalised risk assessment for excipients"

The new Guidelines for good manufacturing practice for excipients pack a punch. In parts the requirements go far beyond the terms of the guideline draft of February 2013. Read here what pharmaceutical companies have to observe from now on when ascertaining the appropriate good manufacturing practice for excipients by means of a formalised risk assessment.



Overview about API manufacturing for the European market

EudraGMDP provides some interesting information about the API manufacturing sites as well as about importers, distributors of APIs to be used as starting material in Medicinal Products for human use in Europe. Please read more about the API registrations in EudraGMDP.



EU Commission issues two final Guidelines: GMP for Excipients and GDP for APIs

The long-awaited guidelines on GMP for Excipients and GDP for APIs have now been published as final versions in the official journal of the European Union. Learn more about the Two final Guidelines on GMP for Excipients and on GDP for APIs.



New information about CEPs and inspections published by EDQM

The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published new information about the CEP procedure and its related inspections. Please read more about he latest updates from EDQM.



ICH announces Q&A Document on Q11 Guideline - Main Focus: API Starting Materials

The ICH has recently published a Business Plan and a Concept Paper on the elaboration of a Q&A document on the ICH Q11 Guideline. Read more here.



Delegated Regulation on GMP for APIs published in the Official Journal of the EU

The bindingness of the GMP principles for APIs has been set in a EU-wide applicable regulation - in a so-called "Delegated Act". Read more here.



New EMA's Reflection Paper on API Starting Materials

The selection of starting materials for the manufacture of APIs frequently leads to delays in procedure for authorisation as the assessors from the regulatory authorities' side are not always happy with the justification of this selection. In a "Reflection Paper", the EMA tries to clarify essential elements on the topic. Read more here.



Saudi Food and Drug Authority publishes Drug Master File Guidance

The submission of documents relevant for authorisation to the Saudi Food and Drug Authority implies the consideration of certain requirements. A new Drug Master File Guidance provides information. Find out more.



New APIC's "How to do" Document: "GDP for APIs"

The Active Pharmaceutical Ingredients Committee (APIC) has recently published a practical guide about good distribution practices for pharmaceutical APIs. Read more here about the new "How to do" document.



BfArM: Production of Active Substances should partially be brought back home from Asia

Prof. Schwerdtfeger, president of the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, the Federal Institute for Drugs and Medical Devices) has demanded a rethinking in policy and pharmaceutical industry in an interview with the the daily paper "Die Welt". In the interview which has attracted much attention he also talked about the actual supply shortages. Read more about the interview with the president of the BfArM.



How does the EDQM process CEP Applications? A new Policy provides Information

To clarify the approach for processing a new application for a Certificate of Suitability (CEP) or an application for the revision of an existing CEP, the EDQM published a Policy this year in March which describes each single phase for the assessment of applications and the respective deadlines. Read more here.



Risk Assessment for ascertaining GMP for Excipients

The EU has published the comments received from the industry regarding the publication of the draft guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use. Please click here to read more



New Q&A Document of the CMDh gives Answers to Essential Questions on the ASMF Procedure

When will the new single EU numbering system for ASMFs be obligatory? Can an ASMF holder have more than one ASMF for one active substance? Those questions and other ones have been answered in a new Q&A document on the ASMF procedure published by the CMDh at the end of September. Read more here.


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