GMP News - APIs and Excipients


GMP-Audits of manufacturers of active substances: Minimum Requirements on Audit Reports and Qualification of Auditors

EMA’s Inspectors Working Group defines concrete criteria for the quality standards of audit reports of active substances and for the qualification of auditors in its list of questions and answers updated recently. Get more detailed information on the criteria here.



Canada: GMP Requirements now Applicable to all APIs

A press release which has recently been published by Health Canada informed about the extension of GMP requirements to APIs. According to these new requirements, the manufacture of APIs will have to be GMP-compliant as of 8 November 2013. Read more here.



Written Confirmation: Australia gets on the List of "Third Countries"

After Switzerland, Australia is the second country to get on the list of countries who won't have to issue "Written Confirmations". Read more here.



Written Confirmations: Questions & Answers Document Version 4.1 published!

The EU Commission has published a new update of the Questions & Answers document on the "Written Confirmation". Version 4.1 presents answers to 2 new questions on topics which hadn't been clarified so far. More details here.



Comparison of EU GMP and Indian GMP Requirements for APIs

Within the framework of the Written Confirmations to be issued as of 2 July 2013, the question of how equivalent GMP regulations in different countries are is being raised. A comparison of EU's GMP Part 2 (ICH Q7) and the Indian GMP regulations is now available. Read more here in the GMP News.



Future Quality Requirements on Essential Oils in Europe

From a regulatory point of view, essential oils used as APIs in herbal products raise a broad range of questions. Currently, there is no EMA/HMPC Guideline on the topic. A "Reflection Paper" from 15 January 2013 invites interested stakeholders to express their opinion. Further details can be found here in the News.



New Information on Written Confirmation from the EU Commission

Hardly any other subject is as extensively discussed in the GMP environment as the so called Written Confirmations. Now the EU Commission has issued new information. Read more.



FDA seeks getting on the List of Third Countries with equivalent GMP Standards

The US FDA seeks getting on the list of so called third countries and has therefore filed a listing request. Find out more.



European Commission Publishes Extended Question/Answer Document on Written Confirmation

The EU Commission has recently published an extended Question and Answer Document on APIs importation into the EU and the "Written Confirmation". In addition, an up-to-date version of the "Written Confirmation" form has been released. Read more here about the changes made in both documents.



Guidelines for formalised Risk Assessment of pharmaceutical Excipients issued

Recently the EU Commission issued draft guidelines on the formalised risk assessment of pharmaceutical excipients. These drafts comprise definite specifications for determining the risk profile of the excipient and the manufacturer which the pharmaceutical manufacturer using these excipients has to apply. Read more.



New MHRA Q & A Document on the Import of Active Pharmaceutical Ingredients

The British regulatory authority MHRA has published a new questions-and-answers document concerning the new rules on the import of active ingredients laid down in the Directive 2011/62/EU on the prevention of the entry of falsified medicinal products. Read more here.



ICH plans Q&A on ICH Q7

The International Committee for Harmonisation (ICH) has published a concept paper on 17 October 2012. According to the announcement the ICH Implementation Working Group (Q7 IWG) is currently working on a Q7 Question and Answer document. Go here to read more.



EU Commission publishes Version 2.0 of the Question and Answer Document on API Importation

The European Commission has published a Version 2.0 of the Q&A document "Importation of Active Substances for Medicinal Products for human use" on 26 October. Version 1.0 was published on 10 July 2013. Please read more here.



Additional Guidance Document on Active Substance Master File (ASMF) published by EMA

The European Medicines Agency (EMA) has published an additional Guidance document relating to Active substance Master Files (formerly known as European Drug Master File). Find out more.



Chinese API Manufacturers revealed to have used gutter oil for the Manufacture of Antibiotics

Local Chinese authorities are currently investigating against a few renowned API manufacturers who are accused of having used waste oil from restaurants for the production of their antibiotics. China's largest API manufacturers are among the accused manufacturers. Read more.


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