News
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The ICH Q12 guideline for pharmaceutical product lifecycle management has reached Step 4 and the final version has now been adopted
Background There is currently a lack of harmonisation in technical and regulatory considerations for pharmaceutical product lifecycle management. Implementation of post-approval changes takes time, and the post-approval change system is not harmonised globally. The Common Technical Documentation (CTD) format defines the content of a marketing authorisation application but there is no common agreement about which […]
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DO YOU KNOW WHAT TO DO TO AVOID NITROSAMINES IN YOUR HUMAN MEDICINAL PRODUCTS?
Background According to the European Medicines Agency’s (EMA) press release on 26 September 2019, EMA’s human medicines committee (CHMP) is requesting that all marketing authorisation holders (MAHs) for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. If nitrosamines are detected, MAHs must inform authorities […]
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Data integrity enhanced even further in Medfiles’ laboratories
The laboratory information management system (LIMS) has now been validated in our laboratories in compliance with the GMP requirements. The system will be implemented in phases. We have started with stability study management and will move on to other research types, such as pharmaceutical products and raw materials. LIMS produces electronically signed certificates of analyses […]
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MDR 2017/745 will strengthen the co-operation between Competent Authorities for medicines and Notified Bodies
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices entered into force on 26 May 2017. Accordingly, the transition period of 3 years is coming to an end in the spring of next year. The term “combination product” has been in use in the USA for a long time, but […]
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Did you know that deadline for a risk assessment of elemental impurities for veterinary medicinal products is approaching?
Background Risk assessment of elemental impurities became mandatory for new marketing authorisation applications of human drug products in June 2016 and for human drug products already in the market in December 2017, when the ICH Q3D guideline was implemented. The revised European Pharmacopoeia General Monograph Pharmaceutical preparations (2619), which came into effect in January 2018, requires […]