Tune Tibesso Desta, Gabriel Tesfaye, Balcha Balla Tamrat, Belete Anteneh
Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Department of Pharmaceutical Technology, School of Pharmacy, College of Health Sciences and Medicine, Wolaita Sodo University, P.O. Box 158, Wolaita Sodo, Ethiopia.
Adv Pharmacol Pharm Sci. 2024 Dec 7;2024:6109415. doi: 10.1155/adpp/6109415. eCollection 2024.
Good manufacturing practice (GMP) is a part of quality management that maintains product quality and manages it according to the criteria of fitness for use. The heating, ventilation, and air-conditioning (HVAC) system comprises the equipment, technology, and procedure that ensure product quality through maintaining heat, ventilation, and coolness of pharmaceutical manufacturing firms. The aim of the study was to evaluate the GMP compliance of HVAC systems and assess the opportunities and challenges of improving these systems in pharmaceutical manufacturing companies in Ethiopia. The study was conducted in eight local pharmaceutical manufacturing companies in Ethiopia from April 20 to August 30, 2021, by using a concurrent mixed-method approach to evaluate the implementation of GMP in HVAC systems. The pharmaceutical firms were directly observed by using a structured and standard observational checklist that was adopted from the WHO minimum GMP requirements. In order to understand the challenges and opportunities, face-to-face interviews with key informants using a purposive sampling technique were conducted. The study findings revealed that the local pharmaceutical companies applied for 67.1% of the GMP requirements of the HVAC systems. The GMP implementation status in the basic quality features of HVAC systems of local pharmaceutical companies was 75% on premises, 70.67% in HVAC system design and maintenance practices, 56.25% in product protection, 61.25% in environmental protection, and 75% in cross-contamination prevention. The primary obstacles to implementing GMP in the HVAC systems were a shortage of skilled professionals, HVAC system spare parts, and foreign currency besides poor practice of HVAC system calibration. The study revealed that the local pharmaceutical manufacturing companies did not adhere to GMP standards in HVAC systems.
良好生产规范（GMP）是质量管理的一部分，它能维持产品质量并根据适用性标准进行管理。加热、通风和空调（HVAC）系统包括通过维持制药企业的热度、通风和凉爽度来确保产品质量的设备、技术和程序。本研究的目的是评估埃塞俄比亚制药企业HVAC系统的GMP合规情况，并评估改进这些系统的机遇和挑战。该研究于2021年4月20日至8月30日在埃塞俄比亚的八家本地制药企业进行，采用了同步混合方法来评估GMP在HVAC系统中的实施情况。通过使用从世界卫生组织最低GMP要求中采用的结构化和标准化观察清单，对制药企业进行了直接观察。为了了解挑战和机遇，采用目的抽样技术对关键信息提供者进行了面对面访谈。研究结果显示，本地制药企业达到了HVAC系统GMP要求的67.1%。本地制药企业HVAC系统基本质量特征方面的GMP实施状况为：场所方面75%，HVAC系统设计和维护实践方面70.67%，产品保护方面56.25%，环境保护方面61.25%，交叉污染预防方面75%。在HVAC系统中实施GMP的主要障碍除了HVAC系统校准实践不佳外，还包括缺乏熟练专业人员、HVAC系统备件和外汇。研究表明，本地制药企业在HVAC系统中未遵守GMP标准。
