Assessment of cross-contamination prevention practices in pharmaceutical production: a comparative case study of two pharmaceutical manufacturing plants in Ethiopia
No Thumbnail Available
Date
2017-12
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Addis Ababa Universty
Abstract
Introduction: It is vital for pharmaceutical manufacturing companies to protect their customers’ health by manufacturing safe and quality medicines by adopting Good manufacturing practices (GMP), tools which help to ensure achieving this target sustainably. Among others, cross-contamination should be avoided by robust design of the premises, equipment and processes which take place within a manufacturing facility. The Food, Medicine, Healthcare Administration and Control Authority (FMHACA) has prepared a GMP roadmap for compliance of Ethiopian pharmaceutical manufactures by the Year 2018. Conducting scientific assessments on the companies’ status of cross-contamination prevention can provide pertinent information for the companies to take appropriate interventions on cross-contamination aspects of GMP guidelines.
Objective: The aim of this study was therefore to assess, evaluate and compare the extent of cross-contamination prevention GMP guidelines implementation in the production areas of two Ethiopian pharmaceutical manufacturing companies, Company and Company B.
Methodology: This study was a descriptive study conducted with comparative case study approach. Comprehensive methods that have 2 phases were conducted in June and July 2016 in Ethiopia. Field observation using structured checklist adopted from WHO GMP guideline, data collection from the company’s key personnel and chemical analysis of target residue on randomly selected equipment cleaned with the companies’ existing procedures have been used.
Results: This study revealed that Company A has been operating with less compliance risk with 90.3% rating when compared to company B with 77.2% overall rating. The premises and Heating Ventilation and Air Conditioning (HVAC) system of the two companies were considerably different with critical deficiencies observed in company B. Moreover, the effectiveness of cleaning procedures in reducing active ingredient carryover was better in company A.
Conclusion and Recommendations: Company A exhibited better compliance with no critical deficiency while Company B operated with critical deficiencies and higher compliance risks. In order to achieve GMP compliance with respect to cross-contamination and protect the safety of its customers Company B has to upgrade the manufacturing site and shall focus on solving validation gaps this study revealed.
Description
Keywords
Critical deficiency, Cross-Contamination, Good Manufacturing Practices, HVAC, Premises, Validation