GMP News - Quality Assurance

The EMA supports recommendations for the use of global track & trace systems to mitigate the risk of drug shortages and fight against falsified medicines. To date, track & trace systems have been designed and implemented with a local or regional focus, without taking into account whether they can exchange information with other systems.

During an action week coordinated by INTERPOL against illegal internet trade checks led to the discovery of very large numbers of fake and illicit drugs. Overall the operation resulted in the seizure of around 9 million medical devices and illicit pharmaceuticals.

Data integrity issues continue to be a focus of FDA inspections. Significant problems with data proving the safety, efficacy and quality of manufactured medicinal products were among the reasons for the Warning Letter to the Chinese company BBC Group Limited.

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.

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.

It is official now: the EU Commission has confirmed the full functionality of the Clinical Trials Information System in the Official Journal of the EU. This means that the Clinical Trials Regulation 536/2014 (CTR) will become applicable on 31 January 2022. What are the GMP / GCP changes associated with this?