GMP News - APIs and Excipients


FDA Guideline on Immunogenicity Testing of Therapeutic Protein Products published

In January, the FDA published a guide on immune responses to protein products: "Immunogenicity testing of therapeutic protein products - Development and validation of assays for the detection of antidrug antibodies".



EMA publishes comments on ICH Q12

The EMA recently released comments gathered during its public consultation for the ICH Q12 draft guideline. Read more about EMA ´s overview of comments received on ICH Q12 on pharmaceutical product lifecycle management.



Revision of EMA's Guideline on the Use of Pharmaceutical Water

In the course of the revision of the European Pharmacopoeia which allows the production of WFI with other methods than distillation, the revision of EMA's "Guideline on the quality of water for pharmaceutical use" has become necessary.



Transfusion Transfer of Babesiosis - FDA Draft: Recommendations for Risk Minimization

The FDA published a new Draft Guidance on Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis. The recommendations contained in this guidance apply to the collection of blood and blood components, except source plasma.



FDA Draft Guidance on the risk of Bacterial Contamination of Blood Platelets

With a new draft guidance on the risk of bacterial contamination of blood platelets for transfusion purposes, the FDA wants to give updated recommendations on risk minimization to affected donor institutions and transfusion centers.



Valsartan: New Inspection reveals significant GMP Violations

An inspection by EU inspectorates in collaboration with EDQM has revealed significant GMP violations at a Valsartan manufacturer's site.



USP article on pharmaceutical continuous manufacturing

In the latest edition of the Pharmacopoeial Forum 44(6), the US pharmacopoeia USP has published a so-called Stimuli Article on pharmaceutical continuous manufacturing. Apart from important definitions, the document contains further information on material properties and characteristics as well as risk management approaches for continuous manufacturing.



Management and control of biological raw materials - the EBE Concept Paper

Raw materials used in the manufacture of biopharmaceuticals may show highly different characteristics and risk potentials. Read here why and how risk assessments for raw materials must be performed and where practical advice therefore may be gained.



Frequent GMP Deficiencies at API Manufacturers reflected in Warning Letters - Current Trends

The Warning Letters sent to API manufacturers in the last few months are a source of comprehensive information. A detailed analysis of them unveils interesting facts and trends on GMP violations with regard to the handling of raw data, OOS results and data integrity.



FDA´s draft Guidance on Post-approval Changes to APIs

API manufacturers who want to make changes to the API manufacturing process during an application's post-approval period should read FDA´s new draft guidance for industry: Postapproval Changes to Drug Substances.



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".


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