Soldi A
Ann Ist Super Sanita. 1975;11(3-4):269-80.
Three are the basic features of a medicine legally introduced on the market: efficacy, safety and quality. With regarding to drugs listed in a national or international pharmacopoeia, the ratio between efficacy and safety, within the range of dosage established by the codex, must be considered as official by the industry. As far as quality is concerned, the pharmacopoeia plays a fundamental role in establishing methods of analysis and technical control intended as official reference in case of controversy. The quality of drugs, pharmaceutical adjuvants or preparations listed in a modern pharmacopoeia must be considered by the industry as the minimum level of the acceptable standard for medical use, to ensure efficacy under proper storage conditions. In fact, the specifications are largely based upon suggestions made by manufacturers. Pharmaceutical specialties, being registered by Health Authorities following suitable documentation, do not have to be subjected to the standards established by the pharmacopoeia for new drugs or formulation adjuvants. The constant effort of the manufacturers to minimize risks leads to optimum quality levels, considering that samples used for control by the Health Authorities are usually picked from commercial packages containing a small number of units. To ensure statistical compliance of every sample with official pharmacopoeial standards, manufacturers are forced to exercise the highest care in every process of production and packaging. There cannot possibly be a guarantee that every single unit at the consumer's disposal will actually comply with the quality level established by a modern pharmacopoeia. Optimum quality level in every package of medical products can be achieved by following the "Good Manufacturing Practice" sponsored by the WHO; this goal requires skilled people and sophisticated equipment. The practice of quality control as an essential part of the manufacturing process in a wide range of pharmaceuticals, provides an excellent experience that may be useful to the pharmacopoeial commissions. Therefore a closer co-operation between health officials and industry's experts must be considered the best way to improve the specifications, to speed-up the revision of monographs and to collect reports on stability tests. The part of a modern pharmacopoeia, devoted to tests and standards appears today as the most important for the pharmaceutical industry because, when a controversy arises about drugs, the official methods established by the pharmacopoeia play a fundamental role in the enforcement of law. The task of compiling each new edition of a modern pharmacopoeia is becoming increasingly difficult; to speed revision any time a problem arises, the revision committees may seek advice from the numerous experts of the pharmaceutical industry thus achieving a most profitable collaboration.
有效性、安全性和质量。对于列入国家或国际药典的药物，在药典规定的剂量范围内，有效性与安全性的比例必须被制药行业视为官方标准。就质量而言，药典在建立分析方法和技术控制方面发挥着重要作用，这些方法和控制在出现争议时作为官方参考。现代药典中列出的药品、药用辅料或制剂的质量必须被制药行业视为医疗用途可接受标准的最低水平，以确保在适当储存条件下的有效性。事实上，这些规范很大程度上基于制造商的建议。药品经卫生当局根据适当文件注册后，不必遵循药典为新药或制剂辅料制定的标准。制造商不断努力将风险降至最低，考虑到卫生当局用于检测的样品通常从包含少量单位的商业包装中选取，这导致了最佳质量水平。为确保每个样品在统计上符合官方药典标准，制造商在生产和包装的每个过程中都必须极其小心。不可能保证消费者拿到的每一个单位产品都实际符合现代药典规定的质量水平。通过遵循世界卫生组织倡导的“良好生产规范”，可以实现每包医疗产品的最佳质量水平；这一目标需要技术熟练的人员和先进的设备。在广泛的药品生产过程中，将质量控制作为一个重要环节的做法提供了宝贵经验，这对药典委员会可能有用。因此，卫生官员与行业专家之间更紧密的合作必须被视为改进规范、加快专著修订以及收集稳定性测试报告的最佳方式。现代药典中专门用于检测和标准的部分如今对制药行业最为重要，因为当药品出现争议时，药典制定的官方方法在执法中起着至关重要的作用。编写现代药典每一新版的任务变得越来越困难；为了在出现问题时加快修订速度，修订委员会可以向制药行业的众多专家寻求建议，从而实现非常有益的合作。
