GMP News - APIs and Excipients


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.



The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in the Manufacture of Active Pharmaceutical Ingredients

The occurrence of foreign particles in the manufacture of active pharmaceutical ingredients is always undesirable. For the responsible QA departments it involves an increased effort as concerns the search for the root causes and for CAPA measures. A new APIC Guidance offers concrete recommendations for the GMP compliant handling of foreign particles in APIs, intermediates and raw materials.



FDA Inspections at API Manufacturers - current Warning Letter Trends

The Warning Letters the FDA sent to active ingredient manufacturers last fiscal year, show similar patterns. Find out more about the frequent deficiencies found in the area of responsibility of quality assurance and in the handling of electronic data in production facilities for active pharmaceutical ingredients.



As of September 2015, updated Requirements apply to the Application of a CEP!

The EDQM recently revised its certification policy. Read more here about what you now need to consider when applying for a Certificate of Suitability (CEP).



Actual Interpretation of the GMP Requirements for Active Pharmaceutical Ingredients: APIC revises the "How to do" Document on ICH Q7

The APIC has thoroughly revised the "How to do" document that explains the guideline ICH Q7. Here you can see how the new document interprets the requirements concerning a GMP compliant manufacture of active pharmaceutical ingredients against the background of the current developments.



Written Confirmation: Now also Israel and Brazil on the "Third Countries List"

The list of countries from which the shipment of API batches to Europe is possible without "Written Confirmation" has recently been expanded to Israel and Brazil. Learn more about the regulation for API exports to the EU important for third countries.


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