AM CONSULTANCY

At AM Consultancy,
we specialize in auditing, consulting and implementation
of Good Manufacturing Practices (GMP)
in the pharmaceutical and cosmetic sector.

MEASURES CORONAVIRUS

MEASURES
CORONAVIRUS

Cosmetic Safety Assessment
Training Courses

Remote Auditing For GMP Compliance During COVID-19 Pandemic

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.

References


Testimonials


Ms. Lambert audited our CDMO on behalf of 2 different MAHs. I really appreciated the professional deep competent approach without forgetting we are people and according to this concept the "sovoir-faire" should be something "mandatory". The various knowledge (pharmaceutical, cosmetic) was verified on the spot during the stay at our sites. In pharmaceutical area there are several different transfers, i.e. tech transfer, analytical method transfer etc.; Annemie transferred competence and cordiality.

Davide Valenti

I've known Annemie for over ten years. She combines the ability to convince people through her positive personality with a detailed knowledge of legislation, which makes the ideal person in any Quality Assurance role.

Bram Keymolen

Contact


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 annemie.lambert@amconsultancy.be or by telephone 0032 486 21 92 12.