Good manufacturing practices (GMP) are considered part of the quality control system for companies producing
pharmaceutical
products. GMP principles aim to ensure the regular production for products that conform to the health standards required from regulatory bodies. GMP provides the general basics to determine the minimum acceptable requirements for the production at good products, covering all the activities related to the production process. This paper hypothesizes that, although ISO 9000 certification, which is the world-wide quality management and quality assurance standard, is not required for
pharmaceutical companies, only those with a company culture mature and ethical enough to implement TQM
successfully will be able to successfully implement GMP (industry-specific standard). There has been a great deal of confusion concerning whether being in compliance with the pharmaceutical GMP would successfully lead to obtaining ISO certification with minimum changes and costs, or whether achieving ISO certification is going to be a long and expensive road. This paper hypothesizes that the ultimate success of a company's ISO program will not depend solely on how well-defined its quality system is, but rather its commitment to maintaining GMP.