Remote auditing may be the best alternative for conducting GMP compliance auditing in times of crisis but its use must be balanced based upon the relative risk posed by the organization and the products and services produced or supplied.

Remote audits provide a viable alternative for organizations to ensure continued compliance with good manufacturing practice (GMP) requirements in times of national or global crisis where travel is restricted or prohibited.

These audits leverage technology such as video teleconferencing and shared file folders to facilitate audit interviews and share documents and records for auditing.

GMP standards and regulations do not prohibit the use of virtual or remote auditing techniques.

Remote audits have several advantages over on-site audits including savings in travel costs, flexible scheduling and reduced risk of contamination.

The conduct of remote audits includes provisions of all necessary documents by the auditee, review of facility map and other documents, virtual tour of the facility and review of all pertinent logs.

The best practices for remote audits include conducting it in segments and more like an FDA inspection than a traditional ISO audit.

It is important to ensure that internal and external auditing procedures for suppliers allow the use of virtual editing techniques and document and record-sharing methods are properly functioning.

Both the auditor and auditee must also practice the use of virtual technology platform prior to the audit.

3 KEY POINTS

1. A remote audit can facilitate the conduct of GMP compliance auditing in times of crisis when travel is prohibited or restricted.
2. It uses video teleconferencing and file sharing methods for audit interviews and document evaluation.
3. The best practices include conducting remote audits in segments and like an FDA inspection.

“Remote audits, which leverage technology such as video teleconferencing and shared file folders to facilitate interviews and share documents and records, are a viable alternative to ensure continued compliance with GMP requirements,” says Mark Allen Durivage, an ASQ and SRE Fellow and managing principal consultant at Quality Systems Compliance LLC.

Article source: https://www.bioprocessonline.com/doc/remote-auditing-best-practices-for-gmp-compliance-0001

#Pharmaceutical, #RemoteAuditing, #GMPCompliance, #BestPractices

P.S. Staying up-to-date with what’s new in Clinical Trials? Get the latest articles summarized and delivered free to your e-mail inbox. Click here to learn more.