Why do we need to conduct a GMP audits in israel?
The general definition of an audit or inspection is an evaluation of a person, organization, system, process, enterprise, project, or product. Quality and GMP Audits and inspections are critical functions within the pharmaceutical company. It provides management/health authority/client (in case you are an API supplier) with information about how effectively the company controls the quality of its processes and the safety and quality of its products, to minimize the risks.
In particular, the FDA cGMPs for pharmaceutical products require that an organization will conduct an internal quality audit as well as a third-party supplier audit to determine the effectiveness of its quality system.
GMP Auditors are typically part of the Quality Assurance (QA) or Regulatory Compliance area that has the relevant experience for examining the data trail to determine whether company policies and procedures are followed and implemented properly.
During a GMP audit, the organization should focus to demonstrate that the process of manufacturing drug substances and drug products within the scope and standards of Good Manufacturing Practices (GMP). Organizations should simply ensure that the following six things are completely controlled along with a separate quality control department:
- Raw materials
- Finished products