台灣西藥製劑廠品質管理的倫理問題—以佛教「八正道」的義理架構為實踐路徑=Quality management ethical issues for drug manufacturers in Taiwan — A practical approach based on a Buddhist Noble Eightfold Path thought framework
To comply with the GMP guidance, obey drug manufacturing ethics, and to care about drug products quality are drug manufacturers’ duty and responsibility. To build a good business culture should be the major direction of effort for drug manufacturers. The quality of drugs is related to patients’ rights. Therefore, patient-centered should be the purpose of drug manufacturing itself. This thesis raises the quality management ethical issues for drug manufacturers in Taiwan. It attempts to solve possible ethical problems when producing drugs by a practical approach based on a Buddhist Noble Eightfold Path thought framework. It is also according to the thoughts as per the Saṃyukta Āgama Sutta《雜阿含經》and Mahāprajñāpāramitopadeśa《大智度論》. In the drug manufacturing factory, release products is the duty of an Authorized Person (AP). AP is playing a very crucial role for monitoring Quality System Management and drug product quality. This thesis claim that Right View (正見) and Adequate thought (正思惟) of Noble Eightfold Path are necessary principles for being a qualified AP. This thesis also emphasizes that the high-quality drugs meet the safety and efficacy conditions which can help patients to solve physical or mental illness, indeed. Therefore, the drug manufacturer is an industry which can help patients to relief their illness and pain. It also an industry which fulfills the responsibilities and obligations at the mean time also help people to “free from suffering”. With regard to the personnel management and occupational training, drug manufacturer also can apply śikṣā (三學) as the important method for enhancing the quality of personnel. At last, we look forward the government implementing regulatory of the certification of AP qualification. This is to assist drug manufacturers continuously improvement on Quality System Management, and to make effort of keep going on the way to achieve the Best practice.
