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 companys 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 auditor's 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.
Auditing Department Basics
Traits/Skills of a Good Auditor
GMP Background Information for Auditors
Conducting the Audit
This course is recommended for individuals with two to three years of direct experience working with the US FDA and PIC/S GMP guidelines who want to develop additional expertise in GMP Certificate Auditing
New auditors or individuals wanting to become auditors
Professionals who are responsible for conducting internal or vendor GMP Certificate audits
Suppliers and others who are audited, such as quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management
GMP Certification Consultants by State