GMP Certification Consultants
GMP (Good Manufacturing Practice) is a system to ensure that products meet food safety, quality and legal requirements.
WHO defines Good Manufacturing Practices (GMP) as "that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization". GMP Certification covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures taken; full traceability of a product through batch processing records and distribution records; and systems for recall and investigation of complaints.
Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company�s compliance with pharmaceutical US FDA GMP Certification regulations and other quality standards like ICH Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditors assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry.
Note: This course is not designed to prepare companies to be audited and does not contain content for medical device auditing.
GMP Certification Consultants by State