GMP News - APIs and Excipients

22.10.15

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.

14.10.15

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.

07.10.15

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.

23.09.15

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).

16.09.15

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.

07.08.15

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.

05.08.15

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.

24.06.15

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.

22.04.15

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.

02.04.15

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.

25.03.15

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.

11.03.15

New information about CEPs and inspections published by EDQM

The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published new information about the CEP procedure and its related inspections. Please read more about he latest updates from EDQM.

07.01.15

ICH announces Q&A Document on Q11 Guideline - Main Focus: API Starting Materials

The ICH has recently published a Business Plan and a Concept Paper on the elaboration of a Q&A document on the ICH Q11 Guideline. Read more here.

03.12.14

Delegated Regulation on GMP for APIs published in the Official Journal of the EU

The bindingness of the GMP principles for APIs has been set in a EU-wide applicable regulation - in a so-called "Delegated Act". Read more here.

22.10.14

New EMA's Reflection Paper on API Starting Materials

The selection of starting materials for the manufacture of APIs frequently leads to delays in procedure for authorisation as the assessors from the regulatory authorities' side are not always happy with the justification of this selection. In a "Reflection Paper", the EMA tries to clarify essential elements on the topic. Read more here.

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GMP News - APIs and Excipients

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

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

FDA Inspections at API Manufacturers - current Warning Letter Trends

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

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

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

Indian and Chinese API Manufacturers in the Focus of European Authorities

ICH Publishes New Question and Answer Guideline

The new requirements of the "Guidelines on the formalised risk assessment for excipients"

Overview about API manufacturing for the European market

EU Commission issues two final Guidelines: GMP for Excipients and GDP for APIs

New information about CEPs and inspections published by EDQM

ICH announces Q&A Document on Q11 Guideline - Main Focus: API Starting Materials

Delegated Regulation on GMP for APIs published in the Official Journal of the EU

New EMA's Reflection Paper on API Starting Materials

Recommended Event

Pharmaceutical Water - Live Online Training Generation, Monitoring & Compliance

GMP News - APIs and Excipients

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

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

FDA Inspections at API Manufacturers - current Warning Letter Trends

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

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

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

Indian and Chinese API Manufacturers in the Focus of European Authorities

ICH Publishes New Question and Answer Guideline

The new requirements of the "Guidelines on the formalised risk assessment for excipients"

Overview about API manufacturing for the European market

EU Commission issues two final Guidelines: GMP for Excipients and GDP for APIs

New information about CEPs and inspections published by EDQM

ICH announces Q&A Document on Q11 Guideline - Main Focus: API Starting Materials

Delegated Regulation on GMP for APIs published in the Official Journal of the EU

New EMA's Reflection Paper on API Starting Materials

Recommended Event

Pharmaceutical Water - Live Online Training Generation, Monitoring & Compliance

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