A repacker in the US has recently received a Warning Letter from the FDA. The described deficiencies are repackaging of products in non-equivalent primary packaging, the lack of cleaning validation and the establishment of a suitable quality unit.
In last week's newsletter you could read about part I of Q&As on cleaning validation - asked during ECA's first Cleaning Validation Online Training Course in September. The ECA would like to share a selection of these Q&As on Cleaning Validation - now in part II.
In September the ECA offered the first Cleaning Validation Online Training Course - with many questions for the speaker. The ECA would like to share a selection of these Q&As on Cleaning Validation with the community.
Due to the Covid-19 pandemic, on-site audits by Notified Bodies are partly only possible to a limited extent or not at all. What are the alternatives? A guideline of the Medical Device Coordination Group (MDCG) provides information on this.
Medical devices are essential medical tools and that is why health authorities are also interested in their development. For this purpose, the FDA has presented a catalog of tools for the development of medical devices.
The reprocessing of single-use devices in the medical device sector is left to the EU Member States. However, only the national law of the respective member states must allow this. Now, an implementing regulation is available which describes common specifications for reprocessing single-use devices.
A successfully completed process validation is one of the basic GMP requirements for a product to be marketed. So, how does an authority react if a product is already on the market but no process validation has been carried out? The FDA provides answers in a current Warning Letter.
In the course of a survey in the GMP/GDP environment, about 200 questionnaires were filled out. The aim of the survey was to record the current status of the implementation of GMP/GDP training measures in the pharmaceutical industry. Read more here about the results of the survey on GMP/GDP training.
The "5th Annual International Conference - Good Distribution Practice" organised by the Quality Association of Serbia was held in Belgrade, Serbia on 26th September 2020. The Director of Regulatory Affairs and Communications, Prabjeet Dulai, was invited by the Program Committee to represent the ECA GDP Association and give the introductory session, aptly titled "The Power of Building Relationships - role of the European GDP Association."
The Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a Guidance called "Acting as a Responsible Person (import) from 1 January 2021". The guidance describes the role of the Responsible Person (import) (RPi) and how to become a RPi.
The U.S. FDA revised the text of their "intended use regulation" to provide additional examples and explanation. In particular clarity is provided by describing examples of types of evidence the agency would consider relevant to determining the intended use of a product.
The new FDA Guidance for industry reflects the current state of knowledge regarding nitrosamine impurities. Read more here about what measures the FDA expects from medicinal products and API manufacturers to take to mitigate the risk of nitrosamine contamination.
A US-American pharmaceutical manufacturer was inspected by the FDA in February 2020. Due to serious deficiencies in the media fills and smoke studies in the aseptic area, the manufacturer has now received a Warning Letter.