A GMP audit, its planning and implementation is an important part of the quality management system for pharmaceutical companies. They help to ensure that products are manufactured according to GMP guidelines and that facilities are clean and well organized. Dephamon has extensive experience with GMP audits and offer a variety of services from planning to conducting and documenting the audits. I am also available to answer any questions you may have about self-inspections or supplier and subcontractor qualification. Contact me today to learn more about how you can optimize your audits.
GMP Audit - Self Inspection
The objective of self-inspections is to verify that the requirements of Good Manufacturing Practice are met and to take appropriate action if deficiencies are observed during the inspection (“Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures”. Eudralex Vol 4, Chapter 9 Self inpection). The frequency and duration of these inspections are up to the company. In general, each area of the company should be subject to self-inspection with some regularity, starting with purchasing, employee training, equipment qualification, manufacturing, quality control, shipping and quality assurance. An inspection plan lists the individual areas and defines the regularity of the self-inspections.
It must also be defined what qualification an auditor must have. In particular, the auditor should have good knowledge of good manufacturing practice, but should not be an employee of the department to be audited, otherwise impartiality may not be guaranteed. For smaller companies in particular, it therefore makes sense to involve an external auditor in the meantime.
Last but not least, there must be instructions on the form in which the audit report is to be prepared and by when it must be written. A procedure for dealing with deficiencies should also be in place.
With my many years of experience in audits and inspections, I am happy to assist you in carrying out the self-inspections and/or in processing the deficiencies and optimizing the processes.