GMP News - APIs and Excipients


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.



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.


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