Abstract:


"Introduction: The quality of finished pharmaceutical products, including ophthalmic preparations, depends on good manufacturing practices, adherence to the established standard operating procedures, and availability of clean room requirements in manufacturing facilities. Inability to comply with these requirements leads to poor quality of the products. This study aimed to determine the sterility level and API content of imported and locally manufactured prednisolone and chloramphenicol eye drops

Methods: This laboratory-based analytical study was conducted at Tanzania Medicine and Medical Devices Authority (TMDA) laboratory, Mwanza, Tanzania. Imported chloramphenicol and prednisolone eye drop samples were obtained from community pharmacies in Nyamagana, Mwanza whereas, the locally manufactured samples of the same were obtained from Kilimanjaro Christian Medical Centre. Prednisolone and Chloramphenicol eye drop samples were analysed by membrane filtration and HPLC methods for sterility and API content, respectively.

Results and Discussion: All prednisolone eye drop samples were found to be sterile whereas, two samples out of four, for chloramphenicol eye drops, failed the assay test, according to pharmacopoeia standards. Locally manufactured chloramphenicol eye drops passed the assay test which suggests that local manufacturers are capable of producing high-quality and reliable pharmaceutical products.

Conclusion: All prednisolone eye drop samples were found to be sterile whereas only two chloramphenicol eye drop samples passed the assay test. The TMDA should withdraw from the market, chloramphenicol eye drops which failed the assay test."