CRED 8 Presentations

01/07/2024

Inspections CP, MRP and DCP

• GCP and GMP Inspections may be conducted during the MAA review if the company has not undergone a recent GCP inspection. • EMA (RMS in MRP/DCP) will write to the applicant explaining that an inspection will take place, providing inspection • A site master file or trial master file for use in preparing and carrying out the inspection will be necessary. Access to this file will be required at the sponsor site • Inspectors will send the draft Inspection Report to the manufacturer within fifteen days of the Inspection for comments on major factual errors, points of disagreement or remedial actions. • Applicant given 15 days to respond to the draft report • Favourable inspection reports with all major objections resolved needs to be available by Day 180

The Organisation for Professionals in Regulatory Affairs

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Manufacturing aspects –QC testing and QP release (CP, MRP and DCP) • A QP declaration is required for marketing authorisations to confirm that the active substance has been manufactured in accordance with good manufacturing practicefor medicinal products. • a QP declaration is required from each registered EEA manufacturer and Importer Authorisation Holder (MIAH) that uses the active substance as a starting material and/or is responsible for QP certification of the finished batch of a human or veterinary medicinal product. • When more than one MIAH is involved, rather than provide multiple declarations it may be acceptable to provide a single declaration signed by one QP Format • QP Declaration QP declaration guidance and template adopted by CMDh, CMDv, CHMP and CVMP (with CVMP editorial amendments) March 2014 (europa.eu) • Included as an annex to the eAF

The Organisation for Professionals in Regulatory Affairs

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