GMP News - APIs and Excipients


CEPs: What Applicants and Authorisation Holders should know!

Due to the corona pandemic, many processes and regulations are currently in change - information regarding the current procedures for applying for CEPs is listed on the EDQM website.



Outsourced Activities in the GDP Environment: When is a Contract necessary and what Aspects should be covered?

Many transport services in the distribution and supply of medicinal products are carried out by external logistics service providers, and also other activities in the GDP environment are often outsourced. In this context, the question arises in which cases it is necessary to sign a Technical/Quality Agreement, which regulatory requirements apply, and which aspects should be covered in such an agreement.



FDA Warning Letter: Lab Data Integrity still in the Focus

The U.S. FDA issued a Warning Letter to the US American contract testing laboratory “International Trading Pharm Lab Inc” due to significant violations of cGMP regulations and the inaccurancy of electronical data for Active Pharmaceutical Ingredients (APIs).



New Ph. Eur. Chapter on Essential Oils

The general Ph. Eur. monograph on Essential Oils has been published for comment in the recent issue of Pharmeuropa together with a proposed new Ph. Eur. chapter 5.30. Monographs on essential oils.



FDA Warning Letter: No Compendial Methods established? Develop appropriate Testing Procedures by yourself!

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Romania-based manufacturer of an unapproved new drug due to, among others, releasing drug products without conducting identity and strength testing.



FDA Warning Letter: Incoming Analysis of Raw Materials - Performing only an Appearance Test is not enough

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Danish drugmaker for serious GMP violations, including inadequate testing of finished products. Furthermore, the company failed to conduct at least one test to verify the identity of each component of a drug product.



Shredding Key Documents and Leading Investigators to Incorrect Rooms - An unusual FDA Warning Letter

FDA Warning letters often refer to insufficient documentation, missing validations, inadequate training, employees not following procedures, or similar cases. But shredding documents and leading investigators to incorrect rooms during an inspection is rather unusual.



FDA Warning Letter to Indian Manufacturer for Inadequate Testing of Incoming APIs

 In a Warning Letter to an Indian manufacturer, the FDA notes that the firm lacked adequate testing for incoming API and relied on the suppliers' certificates of analyses (COA) without establishing the reliability of the suppliers' analyses through appropriate validation.



Annex 1: European Commission Publishes Revised Document

On 20 February, the European Commission published the long-awaited revision of Annex 1 Sterile Manufacturing of the EU GMP Guideline. The document is now entering a timely limited commentary phase.



FDA publishes Questions and Answers on Pathogen Reduction in Blood Components

With their new questions and answers paper, the FDA wants to provide further information on the implementation of pathogen reduction techniques for blood establishments.



Stability Testing Program as a Common Problem in recent FDA Warning Letters

Stability testing of drug products is required by 21 CFR 211.166 of the cGMP guidelines. There has been an increase in GMP violations related to stability testing. A few days ago, a German company received an FDA Warning Letter in which, among others, the stability program was criticized.



EDQM Launches a New Website on Nitrosamine Contamination

Anyone who has gradually lost track of the mass of information about nitrosamine impurities can now consult the EDQM website. Read more about where to find important documents, e.g. analytical methods of determination on the new EDQM website for nitrosamines.



FDA Warning Letter for Chinese Manufacturer highlights the Importance of the Quality Unit

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Henan Kangdi Medical Devices Co. Ltd. due to, among others, the failure to establish an adequate stability program. Furthermore, the quality unit was not provided with the appropriate authority and sufficient resources to carry out its responsibilities.



Warning Letter for not meeting FDA/USP Requirements

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Wild Child WA Pty Ltd., that summaries three significant GMP issues identified during a 5-day inspection of the company's manufacturing facility in Malaga, Western Australia. The core issue is the non-compliance with requirements specified in the United States Pharmacopeia (USP).



Potential sources for Nitrosamine Impurities

Nitrosamines have already been detected in a large number of medicinal products. Where do they come from and how are they transferred to the final product? Read more here about the causes for nitrosamine impurities that have already been identified and what should absolutely be taken into account in the risk assessment of medicinal products.


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