· 8 min read
This article, the second in our explainer series, looks at the need for Good Manufacturing Practice audits, what is involved, and how we can help.
GMP audits help ensure products are made and controlled in accordance with appropriate quality standards, and current industry best practices, and that they comply with applicable health authority regulatory requirements and guidance documents. As regulations continue to evolve, authorities are demanding increased vigilance of the pharmaceutical supply chain and emphasizing the need for the application of Quality Risk Management during the audit process. Manufacturers are required to conduct regular GMP audits of their suppliers or have them conducted on their behalf by appropriately qualified and trained auditors. Not only does compliance with GMP help manufacturers meet drug product requirements, but the framework also provides management with information on how effectively the quality of their processes and products are being controlled.
The length of a GMP audit depends on the risks, including complexity of the manufacturing process, company size and their history of compliance, but typically takes between one to three days for a simple audit or up to ten days for a very complex site. Audits can be undertaken on-site, virtually, by desk top assessment or a combination depending on risk/history.
Example of audits include:
Upon completion of the audit, the auditee receives a report and a discussion of the findings, including recommendations on any improvements that may be required.
NSF’s team of former regulatory agency inspectors and experienced industry experts can perform audits and mock inspections across the entire product lifecycle, including GLP-GCP-GMP-PV and GDP.
Audits by independent third-party experienced auditors can help pharmaceutical firms to identify possible gaps in GMP compliance and understand the associated risks. This audit could be of the company’s own facility, perhaps as part of an internal audit program, or of a supplier/service provider to the company.
NSF GxP audits and subsequent remediation plans are trusted by pharmaceutical and biotech companies and regulatory agencies around the world.
NSF can help you prepare for regulatory authority inspections. Our team of former inspectors from the US FDA, MHRA and other regulatory bodies, along with our experienced industry specialists, are currently collaborating with companies around the globe to help them prepare for upcoming inspections. Our support not only helps identify gaps in compliance, but we also work with you to develop/implement CAPA plans, mitigation strategies, mentoring staff and support you with your inspection readiness.
Today’s pharmaceutical auditor needs auditing skills, technical skills and up to date knowledge of the latest regulatory requirements. We offer a range of virtual and in-person training courses for auditors and prospective auditors. From the ‘Internal Auditor’ undertaking self-inspections to the formally qualified ‘GMP PQS Lead Auditor (CQI & IRCA Certified Training).’ Our in-house courses can be tailored to meet the needs of your auditors, including both technical training relating to pharmaceutical processes and controls and training/mentoring for auditors in the audit process.
If you are going to outsource your auditing, here are some things to consider from NSF’s Executive Director Lynne Byers: “The EMA Quality of Medicines Question and Answers provides detailed guidance on steps to take when outsourcing audits. Specifically, they answer the question, ‘Is an audit performed by a third party acceptable?’ It is acceptable to outsource audits but there must be appropriate controls in place.
“It is important there is a contract and quality technical agreement in place (reference EudraLex Volume 4, Part 1, Chapter 7) and that the contract giver has assessed the contract acceptor’s capability to perform the service. “Both parties must also ensure that there are no conflicts of interest (e.g., a commercial relationship between the organization performing the audit and the organization being audited) or a personal conflict of interest of the auditor, for example, being employed by the auditee within the last three years or having a financial interest in the auditee.”
When access to your supplier’s facilities is limited or not permitted, how can you assure yourself of the quality standards in operation to provide continuity of supply of medicinal products?
How can you best prepare for a post-pandemic on-site GMP Inspection? We examine the issues in this video and article transcript.