GMP News - APIs and Excipients


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.



EMA's new Draft Guideline on the Sterilisation of Medicinal Products, APIs, Excipients and Primary Containers

For medicinal products administrated in sterile form, the process to reduce the microbial level is a critical manufacturing step with regard to quality. The EMA has recently published the draft of a guideline on that topic which contains a range of clarifications. Read more about the coming requirements on sterilisation of medicinal products, APIs, excipients and final containers and how to document them in the marketing authorisation dossier.



Quality Documentation of API mix in the Marketing Authorisation Procedure

For different reasons, the manufacture of APIs may sometimes require adding excipients. In the context of an authorisation procedure, this practice reveals to be problematic. Read more here about the data required for the quality documentation of a API mix in an ASMF or a CEP.



European Non-Compliance Report due to the Lack of Transparency regarding the Sourcing of Starting Materials

This year in February, European GMP inspectors discovered critical GMP deficiencies at an Indian API facility. Read more about the lack of transparency of the supply chain, the insufficient documentation system and the lack of data about process validation at this site.



New FDA Guidance on Completeness Assessements for Type II API Drug Master Files

Since 1st October 2012, special regulations have been applying to the US Type II Drug Master Files. This year in February, the FDA published a new Guidance for Industry. Read here what the DMF holder has to consider when submitting data about the API Drug Master File.



Chinese Heparin Manufacturer again involved in Falsification and GMP Non-Compliance

The Heparin Scandal has changed the regulation and the enforcement actions against API manufacturers like no other case in the last 20 years. Now, it seems that falsified Heparin was detected again at a manufacturer in China. Read more about the background of the Heparin case and the GMP Non Compliance Report issued in EudraGMDP for Dongying Tiandong Pharmaceutical.



Fraud and Major GMP Violations at API Manufacturers in India and China

Two Non-Compliance reports to API manufacturers from the Far East  published in the EudraGMDP database reveal once more that basic requirements laid down in the ICH Q7 Guideline are not implemented. Read more details about those Non-Compliance Reports.



When can a Chemical Substance be qualified as a "New Active Substance"? The New Reflection Paper of the EMA gives Information

A new Reflection Paper of the EMA describes the assessment criteria for new active substances. Read in this News which evidence is required from the applicant to claim the "New Active Substance" status for a derivative of an authorised active substance.



Further Regulations within the CEP Procedure: Changes in Contact Persons and Complaints Procedure

Two documents of the EDQM regulate matters which haven't been covered by "public documents" so far. Read more about what has to be considered by applicants or holders of a CEP in case of personnel changes or complaints during a CEP procedure.



Draft of new Ph. Eur. Chapter "Co-Processed Excipients" published

A draft of a new Ph. Eur. chapter  "Co-Processed Excipients" has been published in Pharmeuropa 27.4 with deadline for comments on December 31, 2015. Find out more about the proposed requirements for co-processed excipients.



Ph. Eur. Chapter 5.15. Functionality-related characteristics of excipients

Pharmeuropa 27.4 comprises a draft of Ph. Eur. Chapter 5.15. "Functionality-Related Characteristics of Excipients" - covering the critical quality attributes (CQAs) of excipients. Find out more about the Ph. Eur. Chapter 5.15 draft.



To what extent does the supply chain for APIs have to be documented? The EMA provides the answer

How and to what extent do pharmaceutical companies need to document the origin of pharmaceutical starting materials? Read here, what the EMA expects with regard to the verification of the supply chain for APIs and starting materials.


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