To face the possibility of a Hard Brexit, the MHRA has issued updated guidance proposing some necessary arrangements in regard of Clinical Trials of IMPs.
The EMA published a new guideline on the content, management and archiving of the TMF clinical trial master file (paper and/or electronic).
The International Organization for Standardization has published the new ISO standard "Packaging - Tamper verification features for medicinal product packaging".
In June 2018 already, the International Council for Harmonisation (ICH) announced the coming issuance of a new ICH Guideline on continuous manufacturing. Now, the ICH has released further news about the planned content of the new guideline ICH Q13.
There are regulations for cleaning validation in the pharmaceutical sector and in the manufacture of active ingredients. But what about the cleaning validation of medical devices?
In December 2018, the FDA published its finalised guideline entitled "Manufacturing Site Change Supplements: Content and Submission". The first draft dates back to October 2015. Now, who can use this document?
In its "Medical Device Enforcement and Quality Report", the FDA has published current data on its monitoring activities with regard to medical device manufacturers. Find out what's new.
To face the possibility of a Hard Brexit, the British MHRA has issued an updated guidance proposing some necessary arrangements.
EMA has published a strategic reflection paper "EMA Regulatory Science to 2025". As a consequence, the regulatory landscape, including GMP requirements and standards, needs to be adapted.
With the implementation of the ICH Q9 document, risk management has become mandatory in virtually all GMP areas. This also applies to cleaning validation. But what can such a quality risk management approach look like for cleaning validation? The American Society of Testing and Material (ASTM) has recently issued a guideline on a Science-Based and Risk-Based Cleaning Processes Development and Validation. What does the Guide suggest?