Paper Information

Title:  QUALITY ASSURANCE IN BIOPHARMACEUTICAL INDUSTRIES
Type: SPEECH
Author(s): HOZOURI H.R.,HAMRAZ M.
 
 
 
Name of Seminar: IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY
Type of Seminar:  CONGRESS
Sponsor:  PHYSIOLOGY AND PHARMACOLOGY SOCIETY, MASHHAD UNIVERSITY OF MEDICAL SCIENCE
Date:  2007Volume 18
 
 
Abstract: 

The main responsibilities of Quality assurance consist of performing planned and systematic actions to ensure that the company products meet the quality required for their intended use. Thus Quality assurance principles are to ensure that GMP, GLP and other regulatory codes are respected. Responsibilities are clearly specified, all testing, controls, calibrations, validations, etc. are performed as specified. Products are not sold before the correct authorizations have been obtained Products are appropriately handled throughout their shelf-life. To establish the policy and general procedures for the documents management through its life cycle. To organize and perform quality audits, to determine conformity with Quality System requirements.To establish the general procedures for performing the validation actions. To analyse the performance and consistency of the production processes, through trend analysis of the critical points, coordinating the participation of the related areas. To organize and manage the calibration and verification of the measuring instruments, according to a program and using the adequate standards and reference materials, for ensuring the measurements' traceability. These procedures help assure biopharmaceutical efficacy, safety and quality before to sale.

 
Keyword(s): 
 
Yearly Visit 3  
 
Latest on Blog
Enter SID Blog