GMP News - APIs and Excipients

26.07.17

API starting materials: EMA publishes updated reflection paper

In the recently published updated EMA reflection paper about starting materials, the passage about description of the manufacturing process of an API in an authorisation dossier has been revised. Read more on how to deal with intermediates along the synthesis route which are already monographed in the Ph. Eur. or part of an already authorised product.

26.07.17

The API warning letters of the last 21 months - facts and trends

The warning letters issued to API manufacturers, viewed over a period of one and three quarter years, repeatedly point to fundamental deficiencies. Read here which GMP violations concerning quality assurance, quality control and data integrity were criticised by the FDA inspectors.

19.07.17

Heparin in the FDA's Focus once more: Warning Letter for Chinese Contract Lab

Despite many regulatory initiatives resulting from the heparin scandal, inspections still discover companies linked to contaminated heparin. Read more about the GMP violations concerning the analysis of heparin and the handling of raw data in a Chinese contract laboratory.

05.07.17

WHO's Position on the Import Alert for a Chinese API Manufacturer's Products

When an inspection unearths severe GMP violations, the FDA sometimes issues a ban on imports for the concerned products of a company. Read here what conflicts can arise when such an import alert concerns APIs of a Chinese manufacturer which were classified as prequalified in an inspection by the WHO beforehand.

07.06.17

Production of APIs without any Minimal GMP Standards leads to a Warning Letter for a Chinese Manufacturer

Even 17 years after the publication of the ICH Q7 Guideline, some companies still manufacture without complying with the most important binding GMP instructions and recordings. Read more about what minimal GMP requirements FDA inspectors expected but couldn't find at Changzhou Jintan Qianyao.

31.05.17

Warning Letter due to non-transparent Supply Chain of APIs

The Indian company Sal Pharma has received a Warning Letter due to serious deficiencies with regard to the procurement and storage of APIs, their distribution and disguising information. Read more about what makes the non-transparency of the API supply chain and the procedures highly suspect for the FDA inspectors.

19.04.17

Impurities: Top 10 Deficiencies in New Applications for Certificates of Suitability

The EDQM has recently published a list of the top 10 deficiencies found in CEP applications.Find out how to avoid undesired inquiries from the EDQM on impurities in starting materials, elemental impurities and residual solvents in the framework of an application procedure.

05.04.17

EMA's new Guideline on the Implementation of the ICH Q3D Guideline in the EU

Recently published, the EMA Guideline on the implementation of the requirements of the ICH Q3D Guideline provides support for API and medicinal product manufacturers. Learn more about what you have to consider with regard to the justification and documentation of elemental impurities in the dossier for a marketing authorisation.

30.03.17

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.

08.03.17

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.

08.02.17

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.

21.12.16

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.

07.12.16

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.

09.11.16

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.

02.11.16

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.

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