Industrial Pharmacy

Good Manufacturing Practices

Good Manufacturing Practices is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification. GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. GMP Quality Audits are necessary for assessment of self-inspection in the regulatory aspects of GLP/GCP interface. Roles of pharmaceutical inspection convention and co-operation scheme (PIC/S) are to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.EU-GMP guidelines are needed to maintain the quality which is stricter when compared to WHO-GMP guidelines.CGMP (Current good manufacturing practice guidelines) Quality Principles for Biologics and Medical Devices are required to maintain product compliance.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The GLP Principles describe requirements for and provide general guidance on the conduct of all nonclinical health and environmental safety studies, including invitro studies. Good laboratory practice should be followed for pre-clinical trials. The role of Quality Impact Assessment & effectiveness checks is an essential operation of the pharmaceutical industry. Quality Control Technicians are responsible for assuring quality of the product through all day-to-day operations. They assist the bio manufacturing plant by evaluating raw materials, other supplies and the finished, packaged product. They ensure compliance to common Good Manufacturing Practices. Quality control also plays a major role in analytical method development. General Quality Management is very important for pharmaceutical industries to produce the better product and ensure the maximum safety of healthcare system and also protect waste of money for both government & individual consumers Quality assurance testing is done by using software called Quality Metrics.