GMP News - APIs and Excipients


WHO publishes Guideline on Worker Safety relating to Nanomaterials

Relating to the increasing use of nanomaterials in manufacturing and the possible following risks for manufacturing staff the WHO issued a new guideline document entitled "WHO guidelines on protecting workers from potential risks of manufactured nanomaterials" .



Five new Warning Letters - Four Batch Record Review Citations

Data integrity is for sure still a hot topic in inspections. But it seems inspectors are getting more back to the roots: document and batch record design and review.



Bizarre Warning Letter to Chinese Drug Manufacturer

Over the past months, the ECA reported about the growing number of Warning Letters issued to Asian companies. A recent FDA Warning Letter resulted in a ban on imports for a Chinese manufacturer of pharmaceutical products.



Warning Letter: fundamental GMP Deficiencies in API Production

Fundamental violations of GMP basics in the area of API production found in an official inspection usually lead to unpleasant consequences or, in case of FDA inspections, to a Warning Letter. Read more on which issues concerning in-process controls, documentation and OOS results are intolerable.



API starting materials - New Q&A document for ICH Q11

The recently published ICH question/answer document on starting materials specifies the regulations of the guideline ICH Q11. Read more about what is important in terms of the selection of starting materials and their justification and what data needs to be supplied in the marketing authorisation dossier.



FDA Warning Letters and EU Non-Compliance Reports after Inspections of API Plants - a Comparison

Just like the FDA's Warning Letters which have been publicly available for many years, the EU non-compliance reports are also accessible now for some time past. Therefore, it's interesting to take a look at those deficiency reports which have been addressed to the same manufacturer. Read here which GMP violations by manufactureres of APIs were found by FDA as well as EU GMP inspectors.



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.



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.



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.



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.



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.



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.



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.



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.



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.


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