The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink. Show Short Title: Chapter 1: Pharmaceutical Quality System Internet: https://www.gmp-compliance.org/files/guidemgr/vol4-chap1_2012-06_en.pdf Origin/Publisher: EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Document Type: GMP Guideline Content: Pharmaceutical Quality System Since 2006, the EU-GMP guidelines are requiring a Product Quality Review (PQR) for active pharmaceutical ingredients (API) and finished products with a marketing authorization. Product quality and process stability must be verified and, where necessary, adjusted using suitable corrective and preventive actions. The PQR is a life-cycle document, updated annually and kept throughout the product´s entire commercialization phase. For the US market, an Annual Product Review (APR) must be prepared for API and finished products. The US FDA also requires performance indicators or quality metrics for the assessment, which is not required by EU-GMP guidelines. And more other differences have to be taken into account. A structured approach has proven to be effective for setting up an efficient PQR/ APR. Core considerations are the following 5 points:
Dr. Martin Melzer, Principal Consultant of gempex, will speak about this at the Live Online Seminar of Concept Heidelberg: The Product Quality Review - Requirements and solutions Live online seminar on September 9/10, 2020. The basic seminar is aimed at quality assurance employees in the pharmaceutical industry: pharmaceutical manufacturers, contract manufacturers, manufacturers of active ingredients. gempex as the GMP-Expert supports customers in the form of consulting, training or even relief in the daily GMP routine in all tasks related to PQR / APR, change management or CAPA measures. Volume 4 of “The rules governing medicinal products in the European Union” contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively. On this page:
Introduction February 2011 Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products. Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. Part I Basic Requirements for Medicinal Products Chapter 1 Quality Management (Deadline for coming into operation: 31 January 2013) Chapter 2 Personnel Chapter 3 Premise and Equipment Chapter 4 Chapter 4 Documentation Revision January 2011 Chapter 5 Production Chapter 6 Quality Control Chapter 7 on Outsourced activities Chapter 8 Complaints and Product Recall Chapter 9 Self Inspection Part II Basic Requirements for Active Substances used as Starting MaterialsBasic Requirements for Active Substances used as Starting Materials Part III GMP related documentsSite Master File february 2011 Q9 Quality Risk Management (external link EMA) Q10 Note for Guidance on Pharmaceutical Quality System (external link EMA) MRA Batch Certificate June 2011 Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use version 2, January 2013 AnnexesAnnex 1 Manufacture of Sterile Medicinal Products Annex 2 Manufacture of Biological Medicinal Products for Human Use Annex 3 Manufacture of RadioPharmaceuticals Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products Annex 5 Manufacture of Immunological Veterinary Medicinal Products Annex 6 Manufacture of Medicinal Gases Annex 7 Manufacture of Herbal Medicinal Products Annex 8 Sampling of Starting and Packaging Materials Annex 9 Manufacture of Liquids, Creams and Ointments Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation Annex 11 Computerised Systems revision January 2011 Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products Annex 13 Manufacture of Investigational Medicinal Products Annex 14 Manufacture of Products derived from Human Blood or Human Plasma May 2011 Annex 15 Qualification and validation Annex 16 Certification by a Qualified person and Batch Release Annex 17 Parametric Release Annex 19 Reference and Retention Samples GlossaryGlossary Other documents related to GMPCompilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and procedures What is Section 1.10 of the EU GMP Guide?Even if no manufacturing has occurred in the review period, the quality and regulatory review should be conducted as per section 1.10 and include stability results, returns, complaints, recalls, deviations (including those arising from qualification and validation activities) and regulatory background. What are the requirements for GMP in the EU?GMP requires that medicines: are of consistent high quality; are appropriate for their intended use; meet the requirements of the marketing authorisation or clinical trial authorisation. What is the Annex 21 to the EU GMP guidelines?Annex 21 details the GMP requirements referred to human, investigational and/or veterinary medicinal products imported in the European Union and European Economic Area (EEA) by holders of a Manufacturing Import Authorisation (MIA). What is GMP in product quality?Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice') is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification ... |
