Every organization that is regulated by the authorities and currently also many other industries has been adversely affected by the coronvirus. Ensure your GMP audits and business compliance don’t suffer due to COVID-19 restrictions.
Audits are used for a variety of reasons, including assessing compliance with standards, regulations, and guidances. Adherence to requirements and specifications, evaluating the adequacy and effectiveness of the quality management system, evaluating process and system performance and confirming conformance with contractual obligations.
Audits can be performed on-site when national organized, remotely, or as a combination of remote and on-site activities. The determination to use remote auditing techniques should consider the associated challenges and opportunities. A risk-based supplier and business contract plan should be in place.
At AM Consultancy we have remote audit tools in place to navigate through the different landscape we are facing. Equally, the audit plan is based on ICH-Q9 guidelines and customer specific items. The audit itself is based on the draft PIC/S Guidance document on GMP Inspection Reliance.
The remote audit itself will be done in segments. This allows time for the auditor to review records and generate questions and the auditee to gather records, organize interviews, and formulate responses.
Necessary on-site portions of routine surveillance such as plant tours will be replaced by interviewing subject matter experts and virtual facility tours or will be re-scheduled for when travel restrictions are lifted. An audit report will follow, non-compliance issues noted when applicable.
AM Consultancy is based close to Brussels Airport and can reach out easily to other airports in the Netherlands, Germany or France. Traveling with high speed railway is another possibility to be in the right spot location.
If you require further information about the services offered by AM Consultancy, contact us directly by e-mail firstname.lastname@example.org or by telephone 0032 486 21 92 12.