- Published: Wednesday June 15 2016 09: 10
Medicines regulatory systems worldwide-have always depended upon the knowledge of organisms That develop, manufacture and package, test, distribute and monitor pharmaceutical products. Implicit in the assessment and review process is trust entre les regulator and the regulated que le Information submitted in folders and used in day-to-day decisionmaking is comprehensive, complete and reliable. The data is qui thesis decisions are based shoulds The Therefore be full as well as Attributable Being, legible, contemporaneous, original and accurate, Commonly Referred to as "ALCOA".
Guideline on the sterilization of the medicinal product, active substance, excipient and primary container
- Published: Wednesday May 11 2016 09: 10
This guideline Provides guidance on the documentation expected for sterile products in the quality for file has marketing permission or application changes applying for a medicinal product, (called Expired quality record Throughout The guideline), and the selection of Appropriate methods of sterilization for sterile products.
- Published: Friday April 29 2016 09: 00
The purpose of this guidance is to Clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 210 CFR parts, 211, and 212. Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General; 211 hand covers Current Good Manufacturing Practice for Finished Pharmaceuticals; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography Drugs. This guidance Provides the Agency's current thinking on the establishment and handling of data in according with CGMP requirements.
- Published: Friday April 29 2016 09: 10
The last three chapters of an interpretation of the EU Good Distribution Practice Manual (PEM) Jointly-have-been published by the ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (QGP). Both organizations joined Forces to Develop a Guide Intended to help colleagues in industry with the implementation of the EU GDP Guideline.
- Published: Friday March 25 2016 09: 50
Decision of December 29 2015 on good manufacturing practices Official Journal of the French Republic on January 29 2016, 34 188 text.
This edition includes the latest versions of 3,5,6 and 8 chapters of Good Practices in European manufacturing.