GMP guidelines are not prescriptive instructions on how to manufacture products. They are sequence of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective quality standards. Regulations for manufacturing Parenteral dosage form is very stringent, so it is necessary to understand the similarities and differences among GMP requirements for the manufacturing of Parenteral dosage form & general requirement which are used in manufacturing by the Regulated countries which will be beneficial to the pharmaceutical companies of both ROW countries & Regulated countries.
