Essentials of GMP of manufacturers of medicinal products
In many countries, manufacturers of medicinal products are required, by National Drug Regulatory Authority (NDRA), to manufacture their products in accordance with Good Manufacturing Practice (GMP) requirements. Although, the requirements / regulations / codes / guidelines are varied from country to country from public health situation different, they follow the same principles which are quality management, personnel, premises and equipment, documentation, production, quality control, contracts manufacture and analysis, complaints and product recall, and self inspection. First of all, the holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the marketing authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. Secondly, it has been known that the establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people. There must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. Of the premises and equipment, they have to be located, designed, constructed, adapted and maintained to suit the operations to be carried out. The main purpose of designing of them is to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build up of dust or dirt and, generally, any adverse effect on the quality of products. In the same way as other quality system requirements, the documentation plays a big part of the system. Clearly written documentation can prevent errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing Formulae and instructions, procedures, and records must be free from errors and available in writing. Next, production operations must be the same as what are written in procedures; they must comply with the principles of GMP in order to obtain products of the requisite quality and be in accordance with the approved manufacturing and marketing authorisations. In the connection with personnel principle, production operations should be performed and supervised by competent people, and production premises should be entered by authorised personnel only. Normally, the production of non-medicinal products should be avoided in areas and with the equipment destined for the production of medicinal products.
According to sampling, specifications and testing of the quality control (QC), it has to be ensured that the necessary and relevant tests are done properly, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. QC is not only about laboratory operations, but is involved in all decisions which may concern the quality of the product. The independence of QC from Production is considered fundamental. For contracts manufacture and analysis, they must be correctly defined, agreed and controlled in order to avoid misunderstandings which could lead to an unsatisfactory quality product or work. The Contract Giver and the Contract Acceptor must have a written contract which clearly establishes the duties of each party. Of the handling of complaints and product recall, all complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures. In order to provide for all unforeseen events, a system should be designed to recall (when necessary) promptly and effectively products known or suspected to be defective from the market. In addition, self inspections should be conducted in order to monitor the implementation and compliance with GMP principles and to propose necessary corrective measures. Lastly, the GMP principle is recognised that there are acceptable methods, other than those described in the requirements / regulations / codes / guidelines, which are capable of achieving the principles of GMP. The GMP requirements / regulations / codes / guidelines are not intended to place any restraint upon the development of new concepts or new technologies, which have been validated and provide an equivalent level of Quality Assurance. In summary, GMP is one of the key methods for protection of the public health from the quality defective medicinal products and ensuring that the medicinal products manufactured are of high quality. The NDRA of each country should enforce the GMP as a legal requirement for manufacturing the medicinal products.