Assessment of Implementation of Good Manufacturing Practices (GMPs) at Pharmaceutical Firms in Khartoum State-Sudan
Journal Title: Scholars Academic Journal of Pharmacy - Year 2015, Vol 4, Issue 1
Abstract
Good Manufacturing Practices (GMPs) ,the central part of quality system, is the consistent production of safe and effective product and ensuring that these activities are sustainable. It aims primarily at preventing mistakes and errors involved in any manufacturing activities, such errors are of two types’ mix-up and cross-contamination. GMPs are a legal codification of sound quality principles that have been used by pharmaceutical and healthcare manufacturing industries for over 50 years, (GMPs) are in effect in over 100 countries, and (GMP) compliance is a pre-requisite to exporting pharmaceuticals between countries (GMP ) require that all manufacturing process are clearly defined, systematically reviewed, in the light of experience, and shown to be capable of consistently manufacturing pharmaceutical products, of the required quality that comply with their specifications , and that all necessary resources are provided including: i. Appropriately qualified and trained personnel; ii. Adequate premises and space; iii. Suitable equipment and devices; iv. Appropriate materials, containers, and labels; v. Approved procedures and instructions; vi. Suitable storage and transport; vii. Adequate personnel, laboratories, and equipment for in-process controls; This study aimed to assess the implementation of good manufacturing practices at pharmaceutical firms in Khartoum state-Sudan , the study was also aimed to assess the role played by local regulatory authority in (GMP) enforcement. Keywords: Good Manufacturing Practices (GMP), Premises, Perssonel, and Quality Assurance.
Authors and Affiliations
Gamal Osman Elhassan, Elrashed Elrayah, Abu Bakr Alfadl, Khalid Omer Alfarouq, Riyaz Khan, Kamal Querashi
Keywords
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