EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 1 Manufacture of Sterile Medicinal Products (corrected version) Document History Previous version dated 30 May 2003, in operation since September 2003
2008_11_25_gmp-an1_en.pdf
EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC,
v4_an16_201510_en.pdf
EudraLex - Volume 9A provides guidance for the description of a Risk Management System, which should be provided in the form of an EU Risk Management Plan (EU-RMP) To aid consistency of the format and content of such plans, an EU-RMP template is provided in Annex 5 1 1 of EudraLex - Volume 9A Annex 1 of this EU-RMP template refers to an additional template, which is acting as an
eudralex-volume-9a-questions-answers-implementation-version-54_en.pdf
EudraLex – Volume 4 / 8 – Annex 11: Computerised Systems www kereon ch/A11 Revision 1 – Released on 2011-01-12 Deadline for coming into operation: 2011-06-30 – Page 4 Systèmes automatisés et informatisés Version Française Uniquement pour information Seul le texte original fait foi 4 7 Evidence of appropriate test methods and test scenarios should be
Annex-11-0100FR.pdf
EudraLex Volume 4 – EU Guidelines to Good Manufacturing Practice for Human and Veterinary Use ( EC GMP Guide ) http://ec europa eu/enterprise/pharmaceuticals/eudralex/eudralex_en htm
eu-gmp-requirements-quality-systems-bernd-boedecker_en.pdf
EudraLex Volume 4, Part 1, Chapter 3: Production equipment should not present any hazard to the products The parts of the production equipment that come into contact with the product must not be reactive, additive, or absorptive to such an extent that it will affect the quality of the product and thus present a hazard
9437_risk-based-el_web.pdf
21 CFR Part 11, EudraLex Vol 4 annex 11 for Computerized Systems – Assessment Freelance 2016 Service Pack 1 The Production of drugs for human and veterinarian beings is one of the most critical tasks in the industrial production High quality and accountability standards are an imperative to accomplish it The United States Food and Drug Administration (FDA) as well as the European
2PAA118788 White paper Regulated industries assessment F2016 SP1 v4.pdf
Products of the EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines and contains specific questions about quality work at the GMP facility with references to the corresponding requirements of the regulations and supporting documents The checklist applies only to Advanced Therapy Medicinal Products (ATMP) and should be read
Guide-GMP-checklist-1.0.pdf
Eudralex Volume 4, Chapter I, Pharmaceutical Quality System (PQS), and in other relevant quality system requirements such as ICH Q10, US-FDA 21 CFR part 4, 21 CFR Part 820 and ISO 13485 (1) We conclude that the intention of all these expectations on Quality
efpia-industry-perspective-about-qms-for-drug-device-combination-products.pdf