ICH Q7A – Good Manufacturing Practices (GMP) – Auditor Conversion Training
This training addresses the auditing of pharmaceutical product supply chains, from the producers of raw materials, to the manufacturing of bulk product and follows the requirements of ICH Q7A Good Manufacturing Guidance for Active Pharmaceutical Ingredients (API).
The regulations for GMP compliant manufacturing of drug products are laid down in the laws and directives of the USA, EU, Canada and Japan. Part of this GMP guidance is the mandatory training of all personnel (including technical, maintenance, and cleaning personnel and all others whose activities could affect the quality of the product) that perform duties (for example, manufacturing, processing, packing, or storage of drug products) in production areas and control laboratories.
Continuous basic training on the theory and practice of GMP should be given to all employees and contractors.
On training completion you will be able to:
- Understand GMP requirements for active substance pharmaceuticals
- Help each individual involved in GMP understand their contribution in the GMP framework within an organisation
- Explain how different departments function together with projecting quality, safety, and efficacy of the pharmaceutical products as a cross-functional responsibility
- Understand the reason for adhering to, and developing, a positive attitude towards GMP rules
Contact your SGS Expert now to learn more about Good Manufacturing Practices Auditor Conversion Training.