In pharmaceuticals, food production, and various industries, product safety and quality are paramount. This pursuit led to establishing Good Manufacturing Practices (GMP), a set of principles designed to uphold stringent quality standards throughout manufacturing. These GMP principles encompass a range ...
The newly updated FDA Guidance for Industry on Process Validation: General Principles and Practices ushers in a life cycle approach to process validation. ... H Yang - 《Pda Journal of Pharmaceutical Science & Technology》 被引量: 0发表: 2013年 Commentary on the US Food and Drug Administration...
European Medicines Agency / US Food and Drug Administration joint GMP inspection pilot programme. General principles
L. The application of the GMP to genetic engineering and the biotechnology industry. Tampa, FL: Graphics Marketing Systems, Inc.; 1985:125–144. Technical monograph no. 1: validation of steam sterilization cycles. Washington, DC: Parenteral Drug Association; 1981. Technical monograph no. 3: ...
The United States Food and Drug Administration (FDA) established regulations for electronic records and signatures in Title 21 CFR Part 11 of the Code of Federal Regulations. Effective since 1997 and updated several times since, Part 11 applies to industries regulated by the FDA such as pharmaceuti...
“Quality management in the drug industry: philosophy and essential elements”, outlines the general concepts of quality assurance as well as the principal components or subsystems of GMP, which are joint responsibilities of top management and of production and quality control management. These include...
Finally, the draft document addresses how to handle multiple changes and the logistics of submitting information to EMA. Comments on the draft are due on Feb. 28, 2011. The US Food and Drug Administration issued adraft guidancefor industry on chemistry, manufacturing, and controls (CMC) postapp...
1 ©WorldHealthOrganizationWHOTechnicalReportSeries,No.961,2011世界卫生组织技术 报告系列,编号961,2011年 Annex3附录3 WHOgoodmanufacturingpracticesforpharmaceuticalproducts:mainprinciples世界卫 生组织药品GMP主要原理 Introduction介绍 Generalconsiderations总则 Glossary术语表 Qualitymanagementinthemedicinesindustry:philosop...
Government of Canada, Health Canada, Health Products and Food Branch, HPFB Inspectorate, Inspectorate Ottawa, Compliance, Enforcement and Coordination Division #1, Drug GMP Inspection Unit 被引量: 0发表: 0年 Tradition and Europeanization in Italian Law. By Guido Alpa. London: British Institute of...
With an increasing understanding of clays' physicochemical and mechanical properties, clays are realized as viable for an enhanced performance in a variety of materials and products in the areas of catalysis, food additives, antibacterial functions, polymers, sorbents, and other fields [1–5]. ...