Pre-Inspection Audits Can Help You Prepare for Regulatory Inspections
Inspections by regulatory authorities are restarting across the world. Companies can help ensure that they are ready for these inspections by utilizing third-party specialists to audit their facilities. NSF’s team of former inspectors from the FDA, the MHRA and other regulatory bodies, along with our experienced industry specialists, are currently working with companies around the globe to prepare them for upcoming inspections.
Our team is capable of conducting audits and mock inspections at your facility. They can:
- Audit suppliers and manufacturing facilities
- Assist in developing robust CAPA plans
- Deliver IRCA-accredited training to your staff to ensure that internal audit skills are up to date
- Assist in writing and structuring audit reports
Furthermore, as a global company, we have in-country expertise and can act quickly to support your company’s needs. We are able to provide the following services:
Pre-Approval Inspections (PAIs)
We can perform pre-approval inspections to independently assess readiness. These inspections enable us to identify potential gaps and to address them.
What Is a Pre-Approval Inspection?
A pre-approval inspection is performed to assure regulatory authorities that the facility listed in a drug application can manufacture a drug and that the data submitted is accurate and complete.
Quality System Audits
Quality system audits evaluate a quality management program’s conformance to policies, regulatory requirements and contract commitments. Our experts can assess issues that require action and assist in closing them.
Supplier and Contractor Audits
Our quality risk management approach helps businesses to define which third-party companies or contract manufacturing organizations (CMOs) to audit on-site or remotely. We provide global auditing services for material suppliers, including CMOs manufacturing all pharmaceutical dosage forms, excipients and APIs.
Auditing GLP, GCP, GMP, PV and GDP
Our global capacity enables us to perform audits in each of the above-listed disciplines to ensure adherence to regulatory standards, including those of the EMA, U.S. FDA, WHO, PIC/S and ANVISA.
Due Diligence for Acquisitions
Companies around the world rely on our trusted experts to assist them in the acquisition process. We can carry out regulatory due diligence, as well as facility and equipment assessments, and develop a post-acquisition regulatory strategy.