The Small and Medium Pharmaceutical Industry Centre (SMPIC), NIPER-SAS Nagar, Punjab will be organising two -day seminar on current good and manufacturing practices (cGMP) on April 2 and 3 at its campus.
The seminar will focus on cGMP, the form of standardized protocol that is used in the manufacture of pharmaceuticals, food and medical devices. It was designed to make sure that processes performed, equipments used, in-process testing and end process testing comply within the standards through proper traceable documentation, forming the basis of modern quality system.
The key concepts of cGMP are quality, quality by design and product development, quality risk management, correcting and preventive action (CAPA) and change control.
Eminent personalities from regulatory agencies, academia and pharmaceutical industry will be present at the seminar to deliver the importance of cGMP.
The speakers will stress the concept of cGMP, equipment, design and validation, process control, component of quality management, documentation, risk based approach to GMP and deviation control.
GMP are the practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacturing and testing of pharmaceuticals. But the basic concept of all these guidelines remain more or less similar to the ultimate goals of producing good quality medicine active pharmaceutical ingredients (APIs) for safeguarding the health of patients.
GMP covers all the aspects of manufacturing process including: defined manufacturing process, validated critical manufacturing steps, suitable premises, storage, transport, qualified and trained production staff and quality control personnel.