GMP News - APIs and Excipients


API mixtures and CEP Procedure: What should be considered?

It is also possible to apply for a Certificate of Suitability for API mixtures. However, a few particularities have to be considered. Here, you can read about what must be observed when applying for a CEP for an API/auxiliary substances mixture or an API/antioxidant mixture.



Inadequate Cleaning and Batch Release in spite of Incomplete Quality Control - Warning Letter to an Indian API Manufacturer

During the inspection of an Indian API facility, FDA investigators found that basic requirements for GMP-compliant manufacturing weren't complied with. This led to a Warning Letter. Read more about the detailed deficiencies in cleaning and validation of test methods, and the maintenance of analytical devices.



Written Confirmations - Does the procedure work as it should?

Since January 2013 all imported APIs need to be accompanied by a so called "Written Confirmation" (except a few countries with equivalent GMP standards like the US and Switzerland) which should confirm that the manufacturing site is working under GMP (ICH Q7). But how much does the system help to improve quality of APIs. An investigation of written confirmations issued by the Indian Authorities reveals some surprises. Read more about the Written Confirmations for APIs.



EMA issues new Guideline on "Chemistry of Active Substances"

The new EMA "Guideline on the chemistry of active substances" represents the current state of the art in regulatory practice and fits into the context of the ICH Guidelines Q8-11. Find out what information regarding active substances European authorities expect in an authorization application.



Selection and justification of starting materials: new Questions and Answers to ICH Q11 published

The ICH Q11 Guideline describing approaches to developing and understanding the manufacturing process of drug substances was finalised in May 2012. Since then the pharmaceutical industry and the drug substance manufacturers had time to get familiar with the principles outlined in this guideline. However, experience has shown that there is some need for clarification. Thus the Q11 Implementation Working Group recently issued a Questions and Answers Document.



New EDQM's Public Document informs about the Details required in a New CEP Application for already Referenced Substances

A Policy Document recently published by the EDQM describes regulations for referencing already existing CEPs in an application for a new CEP. Read more about how the certificates of an intermediate or starting material have to be used in new applications for a CEP.



New USP monograph for Hypromellose Capsule shells (HPMC or veggie capsules)

A new USP monograph for HPMC or veggie capsules has been proposed in the Pharmacopeial Forum. Read more about the proposed USP monograph for Hypromellose Capsule shells.



Implementation of ICH Q3D within the CEP Procedure

The EDQM has implemented the requirements of the ICH Q3D Guideline on elemental impurities also for the CEP procedure and has published a new policy document. Read more here about what has to be considered when applying or renewing a CEP, or for already existing CEPs with regard to elemental impurities in APIs.



APIC is working on an enhanced ICH Q7 How to do Guide

Acting on the publication of the ICH Q7 Q&A Document in June last year APIC has decided to elaborate another revision of its "ICH Q7 How to do Document" taking into account these Q&As. Here you will get to know why this upcoming How to do Document is a valuable support for API and API intermediate manufacturers regarding the practical implementation of the ICH Q7 What to do principles.



Written Confirmation expired: Can an API still be imported when produced earlier?

What needs to be considered if an API is produced in the time period of a valid written confirmation but imported after this confirmation has expired? This is answered in a revised Q&A Document of the EU Commission.



Practical Implementation of the Control of Elemental Impurities: EMA's new Guideline Draft

One and a half year after its publication, the ICH Q3D guideline still raises many questions. The EMA has recently published a guideline draft aiming at clarifying the practical implementation of ICH Q3D. Read more here about what is expected in a marketing authorisation application or in an application for a CEP with regard to risk assessment and the control of elemental impurities in APIs and medicinal products.



Indian API Manufacturers remain in the Focus of European GMP Inspectors

Some time ago three Non-Compliance Reports have been published in quick succession in the EudraGMDP database. Those reports deal with inspections performed at pharmaceutical APIs production sites located in India. Read more about the fundamental violations of the requirements for GMP-compliant API manufacturing in those facilities.



EDQM's Annual Report 2015: 18% of the sites inspected were not GMP-compliant

An important part of the CEP procedure by the EDQM is the inspection of the site where the APIs are being manufactured. Read more here about EDQM's Annual Report 2015 containing information about the issuance of CEPs and about inspections done within the certification programme.



Current European Non-Compliance Report for an Indian API Manufacturer

Major deficiencies observed during GMP inspections are entered into the EudraGMDP database by the European monitoring authorities. There, you can find a current Non-Compliance Report issued by the Italian Medicines Agency for the Indian API manufacturer Krebs Biochemicals & Industries Ltd.



EDQM's new Guideline on Electronic Submissions for CEP Applications

As of today (June, 1st 2016), the EDQM doesn't accept any CEP application in paper format. Read more here about the structure of the electronic submission of an application for a Certificate of Suitability and the errors to avoid.


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