Second edition, on the importance of Quality Control of the cultivation conditions, to guarantee a reliable and consistent end-product.
The best way to apply the GAMP5 second edition in CSV Projects - Begin with the End in Mind
The Contamination Control Strategy plays a vital role in the framework of the revised EU GMP Annex 1, encompassing critical control points and.
The use of cannabinoids in veterinary medicine is controversial for ethical and legal reasons. The approval of drugs from the competent authorities...
The ICH GCP E6 Working Group published the draft of the ICH GCP E6 R3 Guidance on May 19, 2023. Stakeholders can provide comments on the guideline.
The EU Commission released a recommendation paper on decentralized elements in clinical trials in late 2022. The document addresses the increasing...
The CCS concept permeates the entire Annex 1 document and is a fundamental principle. It indicates examples and topics that need to be addressed.
Market Authorization Holders are now mandated to undergo the QMS to ensure compliance with the newly implemented laws of the VGVP.
2 of the 10 recommendations could be considered the main important to follow: they underline the importance to act preventing and to manage the.
The EU is the first to try to finally regulate AI as part of its digital strategy. The EU AI Act should pass into law in early 2024.
