standards regulations 标准规范-微生物学.pptVIP

Standards and Regulations in the Pharmaceutical IndustrySylvia Healy Introduction Have seen that end-product testing is not sufficient to ensure quality of a medicinal product Manufacturing process must minimise possibility of contamination occuring, tests carried out at end only as a safeguard Standards and regulations essential for control of microbial contamination during manufacture. Introduction Standards what are they? how and why are they used? who creates them? Regulations what is regulated? how are they regulated? who regulates them? What are standards? Documented agreements Contain technical specifications other precise criteria Examples? What Are Standards? Examples ISO 10993, “Biological Evaluation of Medical Devices” ISO 10555, “Sterile, single-use intravascular catheters” EN 554, “Sterilisation of medical devices – Specification for a terminally-sterilised medical device to be labelled “sterile”” EN 866 parts 1-8, “Biological systems for testing sterilisers” How Are Standards Used? Used as: rules guidelines definitions of characteristics Ensure material, product, etc. are fit for their intended purpose There are hundreds of guidelines and lots of published data – often not comprehensive, therefore erring on side of caution is logical approach. I.e. – self impose the highest standard. A manufacturer may use other standards but must be able to prove that their method is scientifically sound and as rigorous as the accepted standard. Why are they used? Standardization will: Promote harmonization to facilitate international exchange of goods and services Promote cooperation in intellectual, scientific, technological and economic communities Provide a common basis for comparison Who Creates Them? Examples: International Organization for Standardization (ISO) European Committee for Standardization (CEN) International Conference on Harmonization (ICH) ASTM International PIC/S – Pharmaceutical Inspection Convention / Cooperation Scheme. What