Do you manufacture packaging materials for pharmaceutical products? Have the quality of your manufacturing processes and their compliance with current standards recognised with AFAQ ISO 15378 certification - Manufacture of primary packaging for medicines.
Aimed at laboratories and packaging manufacturers, ISO 15378 certification now makes it possible to harmonise the practices of the pharmaceutical industry's upstream sector, which now has a common and internationally recognised management tool.
THE BENEFITS OF THIS CERTIFICATION
- Ensure that your production complies with legal requirements;
- Benefit from improved efficiency and profitability of your operation.
- Enable the identification and reduction of risks, including contamination, and manufacturing errors;
- Enhance the quality of your production.
INSTRUCTIONS FOR CERTIFICATION
Assessment visit (optional): Pre-diagnosis to understand the audit issues and maximise your chances of being certified
Initial audit : Our auditor interviews your teams, analyses your practices, your data with regard to the requirements of the standard
Restitution of the audit : Summary presentation of the audit findings, submission of the audit report
Certification : AFNOR International delivers your certificate and logo for 3 years
Monitoring and renewal: A follow-up audit is planned every year and a renewal audit every 3 years
WHY CHOOSE THE AFNOR GROUP?
- The expertise of the French leader with over 70,000 certified sites in France and abroad
- The reputation of a historical actor in the field of certification of organisations for more than 20 years.
- The strength of a network with 1,750 auditors and assessors to help you succeed
- The proximity of our regional offices and our presence in more than 100 countries facilitates the deployment of your initiatives on a global scale.
- Modular complementary certification solutions adapted to your situation.
- You have a personalised client area to facilitate the management of your certification, the preparation of your audits and to monitor the progress of your approach