GMP-compliance: how to constantly improve the GMP level?
The maintenance and improvement of the GMP level within an organization must be subject to ongoing efforts supported by all levels of the company!
Regular internal audits (=self inspections) by qualified independent auditors including the implementation of meaningful corrective and preventive actions (CAPAs) related to such audits but also related to other “inputs” such as:
- Inspections from national competent health authorities (NCAs)
- External audits from e.g. third parties or customers
- Investigation results from Non-conformities and/or (major/critical) deviations
- Investigation results from customer complaints
and follow-up of the efficiency and consistence of such CAPAs by annual reviews (e.g. management reviews, product reviews, utility reviews etc.) provide suitable GMP measures and means to effectively manage such ongoing efforts. At the same time the knowledge and understanding of GMPs should be constantly further developed by suitable training measures for the employees.
This constant investment in maintaining and improving the GMP level, will be successfully grow the GMP compliance level only if it is supported by all employees i.e. from the Board members/Managing Director to the “normal” worker being responsible for conducting the work in production or quality control.