GMP Audit
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.
GMP Audit - Supplier Qualification
One would like to be able to rely on the quality of outsourced activities. For this purpose, the quality of the delivered products or services must be known and checked from time to time. Supplier qualification is divided into several stages, starting with a contract/order with a clear formulation of the supplier’s obligations and the responsibilities of both parties. Formal verification of the quality of products or services can be done, for example, by studying supplied documents, such as certificates of recognized standards (such as ISO 9001, ISO 17025, etc.). At least for critical products and services, the client should verify their quality and conformity with GMP requirements on site of the outsourced activity.
As with self-inspections, the type of qualification and the exact procedure for carrying it out and documenting it must also be defined in advance for supplier qualifications. A risk-based approach is recommended, whereby the requirement and the degree of inspection of the supplier is defined on the basis of the criticality of the products or services purchased.
The assessment of suppliers and on-site audits should be carried out by qualified and experienced auditors. The audit of suppliers ends with a detailed and timely audit report.
