GMP News - APIs and Excipients


Non-Compliance Report for Indian API manufacturer

During an inspection in March 2018, the French competent authority discovered various GMP violations at the site of an Indian manufacturer. Learn more about the Non-Compliance Report issued on behalf of the EMA.



What information is included in a CEP?

The "Certificate of suitability to the Monographs of the European Pharmacopoeia" (CEP) contains information on an active pharmaceutical substance with regard to the European Pharmacopoeia. It is an important document of the authorisation application. Read more about what information is relevant for a CEP and what do CEP holders and authorisation applicants have to consider.



Warning letter due to lacking cleaning validation, stability testing and content determination

When various active substances are being manufactured in a shared system, there are specific requirements for cleaning validation. Read here how severely defects regarding cleaning validation, stability testing and content determination can affect an FDA inspection at an API facility.



Warning letter due to inadequate document management and GMP non-compliant analytical software

Facilities supervised by the FDA should pay great attention to GMP-compliant processes, especially in the areas of manufacture and quality control; otherwise, they risk failing the inspection and receiving a warning letter. Find out what defects regarding document management and analytical software FDA inspectors found at the site of an active substances manufacturer.



European Commission publishes revised Version of EU GMP Guideline Annex 2

As concequence of the adopted new regulations of GMP for ATMPs, the European Commission published a revised version of the Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use".



Cooperation of international authorities for inspecting API manufacturers

The aim of the International API Inspection Programme is the cooperation of authorities in monitoring and controlling API manufacturers. Read here, by which measures an optimised bundling and efficiency enhancement of the regulatory supervision of API facilities via GMP inspections are to be reached.



Missing glycerin test for diethylene glycol leads to FDA warning letter

Glycerin is often used as an excipient in solid and semisolid dosage forms. For companies supervised by the FDA, comprehensive testing of the incoming excipient is mandatory. Otherwise, they risk receiving a warning letter, like an Irish pharmaceutical company recently did. The deficiencies the FDA inspectors found in the areas of quality control and quality assurance are described here.



GMP for APIs practically applied - the revised APIC "How to do" guideline

The "How to do" document is one of APIC's many Best Practices Documents and has been upgraded to the current state of the art. Read here which practical recommendations in the implementation of GMP for APIs are included in the most recent version of the How-to-do document.



Regulatory classification of API co-crystals in the US Approval Procedure

To use an active substance in a form which ensures optimum processing is important for an efficient production process; but what does that mean for approval procedures? Read here how the FDA classifies active pharmaceutical ingredients in co-crystalline form during an approval procedure.



Warning Letter due to unsuitable Production Equipment and insufficient Process Validation

The minimum requirements for a robust production process are suitable facilities and equipment. Read here about what FDA inspectors identified as root causes for impurities and quality variations in the production of active pharmaceutical ingredients (APIs).



Revised Ph. Eur. Monographs on Excipients due to ICH Q3D

Several Ph. Eur. Monographs on excipients used in semi-solid formulations have been proposed for comment. Read more about the monographs on oils, fats, waxes, emulsifiers.



Auditing Starting Materials - new APIC Guideline defines Standards

The use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured? Find out about what standards for auditing starting materials APIC has defined in their new guideline here.



Warning Letter due to falsified Data and poor Maintenance

The attempt to conceal hygiene deficiencies with inaccurate lab data resulted in a virtually inevitable Warning Letter after an FDA inspection. Read here, which violations of fundamental GMP rules for maintenance and cleaning of production equipment at an API facility were criticised by the inspectors.



Disregard of general GMP Principles at Indian API Facility

During the inspection of an Indian active pharmaceutical ingredient manufacturer, European GMP inspectors were met with severe deficiencies. Read here, which violations of GMP principles for production, laboratory and handling of reference samples led to a Non-Compliance Report. 



FDA revises Guideline on HIV and HCV Testing for the Assessment of Blood Donors

With an update of their guideline on NAT testing of blood and plasma donations for HIV-1 and HCV, the FDA takes account of the developments regarding methods and related regulations.


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