cGMP and Validation in Pharmaceutical Process Technology

GMP is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standard appropriate to their intended use and as required by the marketing authorization. These regulations which have the force of law require that manufacturers processors and packagers of drugs medical devices some food and blood take protective steps to ensure that their products are safe pure and effective. Require a quality approach to manufacturing enabling companies to minimize or eliminate instances of contamination mix-ups and errors. Protects the consumer from purchasing a product which is not effective or even dangerous. GMP regulations address issues including record keeping personnel qualifications sanitation cleanliness equipment verification process validation and complaint handling. Validation is an essential part of good manufacturing practices (GMP). It is therefore an element of the pharmaceutical quality system. Validation as a concept incorporates qualification and should be applied over the life cycle. The execution of validation should be in compliance with regulatory requirements.