GMP News - APIs and Excipients

21.02.23

GDP in the US: Consent Decree of Permanent Injunction against Importer and Distributor of APIs

A federal court has entered a consent decree of permanent injunction against a Florida-based drug importer and distributor. It prohibits the company from distributing active pharmaceutical ingredients (APIs) not manufactured, processed, or held in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). This was preceded by a legal dispute with the U.S. Food and Drug Administration (FDA).

15.02.23

Denmark provides further Guidance on Medical Cannabis

The Danish Medicines Agency has prepared a new guidance for the pilot programme on cannabis products. Amongst others, the document contains GMP and other quality requirements for Danish-made cannabis products.

15.02.23

Comments on FDA Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence published

In December 2022, the U.S. Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence". Comments and suggestions could be submitted until 04 February. After this deadline, the comments received have now been published.

15.02.23

Public Consultation on two Ph. Eur. Chapters on Pharmaceutical Technology Procedures

The European Directorate for the Quality of Medicines & HealthCare (EDQM) issued a press release indicating that public consultation on two Ph. Eur. chapters on pharmaceutical technology procedures has been started. These are the revised general chapter 2.9.3 "Dissolution of tablets and capsules" and the new general chapter 2.9.55 "Characterisation of powder behaviour during compression".

15.02.23

The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

08.02.23

FDA Warning Letter: Acetaldehyde and Acetal Impurities in Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has published two Warning Letters to manufactures of hand sanitizer drug products. In both cases, acetaldehyde and acetal impurities at unacceptable levels were found in several lots. The agency is concerned, because acetaldehyde is considered to be genotoxic, and potentially carcinogenic.

08.02.23

FDA concludes that existing Regulatory Framework is not applicable for CBD

The U.S. FDA has concluded that a new regulatory pathway for CBD is needed that balances the desire for access to CBD products with the regulatory oversight needed to manage risks.

08.02.23

European Inspectors criticise Cross Contamination

In the EudraGMDP database, results of European inspectors are published in so-called Non-Compliance Reports. In the period October-November 2022, there were two reports in the area of GMP, both of which were issued due to cross contamination.

08.02.23

European Commission: Canada Part of the "White List" ?

Furthermore, the "Falsified Medicine Directive (2011/62/EU)" requires a "Written Confirmation" for the import of active pharmaceutical ingredients (APIs) from third countries. The APIs imported from countries on the so-called "White List" are an exception to this. In future, Canada will also be listed on this "White List".

08.02.23

CEPs: EDQM establishes New Procedure

The EDQM (European Directorate for the Quality of Medicines & HealthCare) has adopted the document "Management of CEP guidelines and operational documents for the CEP procedure" by the end of 2022 and has now published it on its website. This document explains the new process for the development of supporting documentation related to CEPs (Certificate of Suitability of Monographs of the European Pharmacopoeia).

01.02.23

Does Heating in a Vaporizer Reduce the Microbial Load in Cannabis?

There is currently an ongoing discussion about the microbiological quality requirements for medical Cannabis depending on the route of administration. To move forward authors from the FDA recently published an article about a microbiological study of bulk Cannabis.

01.02.23

Nitrosamine Impurities: EDQM completes General Monographs 2034 and 2619

The two pharmacopoeial monographs (2034) and (2619) have recently been revised. Read more about the requirements that manufacturers of APIs need to follow with regard to possible nitrosamine contamination in their products.

01.02.23

FDA Warning Letter caused by Lab Data Integrity issues

In December 2022, the U.S. FDA issued a Warning Letter to the Brazilian company "Nortec Quimica SA" after having inspected its site in Rio de Janeiro in July 2022. Significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs) are listed and a long list of Data Integrity remedation activies is required.

01.02.23

USP: Further Updates on "Residual Solvents" published for Comments

The USP chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information provided in chapter <467 RESIDUAL SOLVENTS> and has thus now also been updated. The new draft has already been published on the website of the Pharmacopeial Forum of the USP and can be commented on until 31 March 2023.

26.01.23

FDA Warning Letter due to Inadequate Storage Conditions and Repacking/Relabeling Operations

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a drug repackaging and relabeling facility located in Pennsylvania. The document summarizes significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). It also addresses Good Distribution Practice (GDP) aspects.

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Computerised System Validation - Introduction to Risk Management + GAMP 5 Approach

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GMP News - APIs and Excipients

GDP in the US: Consent Decree of Permanent Injunction against Importer and Distributor of APIs

Denmark provides further Guidance on Medical Cannabis

Comments on FDA Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence published

Public Consultation on two Ph. Eur. Chapters on Pharmaceutical Technology Procedures

The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

FDA Warning Letter: Acetaldehyde and Acetal Impurities in Hand Sanitizers

FDA concludes that existing Regulatory Framework is not applicable for CBD

European Inspectors criticise Cross Contamination

European Commission: Canada Part of the "White List" ?

CEPs: EDQM establishes New Procedure

Does Heating in a Vaporizer Reduce the Microbial Load in Cannabis?

Nitrosamine Impurities: EDQM completes General Monographs 2034 and 2619

FDA Warning Letter caused by Lab Data Integrity issues

USP: Further Updates on "Residual Solvents" published for Comments

FDA Warning Letter due to Inadequate Storage Conditions and Repacking/Relabeling Operations

Recommended Event

Computerised System Validation - Introduction to Risk Management + GAMP 5 Approach Learn How to Plan, Implement and Document Effectively Computer Validation Activities

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