GMP News

Following a draft version, the EMA has now published the final guideline, which describes what documentation is required on the subject of quality for combination products in order to gain and/or maintain a marketing authorization. The guideline consists of 22 pages with 10 chapters.

The HMPC adopted the final Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination with PAs. Amongst others, it is stated that PA specifications are no longer considered necessary for essential oils.

Since the GMP regulations are sometimes not very specific, concrete regulatory guidance on implementation is very helpful. In a current Warning Letter, the FDA specifies their requirements for cleaning validation. What does the FDA require?

One of the objectives of Good Distribution Practice (GDP) and an important aspect for distributors of medicinal products is preventing falsified medicines entering the legal supply chain. In this context, a new post, entitled "Too good to be true? How to play your part in protecting the UK medicines supply chain" has been published on the MHRA Inspectorate blog.

The United States Food and Drug Administration (FDA) has recently published a Warning Letter sent to an Australian manufacturer of over-the-counter (OTC) drug products. The Warning Letter summarizes significant violations of current good manufacturing practice (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.

As a result of problems with contamination of hand disinfectants - like with Burkholderia cepacia, a manufacturer in the USA receives a Warning Letter from the FDA.

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to review the batch documentation?

The EMA published the final reflection paper on "Similarity". The paper shows how statistics should be used in drug development when a comparative assessment of quality attributes (QAs) needs to be made for pre- and post-manufacturing changes, biosimilar development as well as generics´ development.

The FDA is warning against certain hand sanitizers because of side effects and contamination, especially during the COVID-19 pandemic. The latest notifications concern alcohol-based hand sanitizers.

Parenterals must be 100% visually inspected. This is a clear requirement of the pharmacopoeias, just as it is clear that containers with particles must be sorted out. But do the particles found always have to be identified?

In a recently published Warning Letter sent to a Chinese company, the FDA criticises, among other aspects, that analytical test methods were not adequately validated and no system suitability requirements were present.

The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.