The New Medical Device Regulations entered into force on 25 May 2017. The Regulations have a staggered transitional period. The obligations for distributors will apply with the full application of the Medical Device Regulation (MDR) after three years (May 2020) and in vitro diagnostic medical devices (IVDR) after five years (May 2022). Distributors should ensure compliance with the requirements […]
A new Guidance document has been released giving more detail on the GMP expectations when performing sterilisation. The Guidance looks at a number of techniques including steam sterilisation, sterile filtration, dry heat, gas sterilisation and irradiation. A decision tree is provided to included to guide the decision on the most appropriate sterilisation method. The guidance […]
On 22 Feb 2016, the French Authorities issued a Certificate of Non-compliance to THERAVECTYS. THERAVECTYS is a Paris-based, privately-owned, discovery and clinical development biotech company. Created in 2005, as a spin-off of the Pasteur Institute, it work in the field of lentiviral vectors. Following an inspection of its manufacturing operation in Villejuif, the operation was instructed to suspend its manufacturing operations […]
The Office of Regulatory Affairs is re-organising to assure that the quality and standard of Pharma and Medical Device audits is enhanced. Currently the ORA district offices are required to inspect all regulated facilities in their area, be they food, drink, tobacco or pharma establishments. This doesn’t facilitate a build-up of technical expertise.
Going forward the […]
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GMP Training by Walkabout is the ideal solution to GMP Training. GMP Services now offer Gemba GMP Training, a novel approach to your refresher GMP Training. The training is conducted in small groups in the actual […]
I noted in an FDA Warning Letter issued to an Indian Company – Marck Biosciences – in July 2014, that the FDA observed that ‘your head of production reported to our investigator that he completes “in process quality assurance check” fields in the batch record but does not actually perform the listed operations.’. Now, there were […]
KEY INSPECTION FINDING IN 2014
It was clear from FDA inspection trends in 2014 that the integrity of records and data was a key concern. This concern is shared by EU Regulators – as evidenced by its inclusion in many conferences and industry forums. Companies would do well to give themselves a health check in this […]