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Pre-Inspection Audits Can Help You Prepare for Regulatory Inspections

Prepare For The Return of Regulatory Inspections

Sanjay Shetgar, Vice President, Pharmaceutical Services, NSF International

Inspections by regulatory authorities are restarting across the world. Companies can help ensure that they are ready for these inspections by utilising 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.

Regulatory authority inspections are restarting across the world. Companies can help ensure that they are ready for these inspections by utilising third party specialists to audit their facilities. NSF International’s team of ex-FDA, MHRA, and other regulatory body inspectors along with our experienced industry specialists are currently working with companies around the world to prepare them for upcoming inspections.

Our team can conduct audits and mock in sections 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 can provide the following services:

Pre-Approval Inspections (PAI)
We can perform pre-approval inspections to independently assess readiness.  Pre-approval inspections enable us to identify potential gaps and to address the gaps.

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 programs conformance to policies, regulatory requirements, and contract commitments.  Our experts can assess issues that require action and can assist in closing them.

Supplier & Contractor Audits
Our quality risk management approach helps companies to define which third party companies or contract manufacturing organizations to audit on site or remotely.  We provide global auditing services for material suppliers.  This includes CMOs manufacturing all pharmaceutical dosage forms, excipients, and APIs.  

Auditing GLP, GCP, GMP, PV & GDP
Our global capacity enables us to perform audits in each of the above listed disciples to ensure adherence to regulatory standards including EMA, US 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, facility, and equipment assessment, and develop a post-acquisition regulatory strategy.

Book A Call
Book a call today with one of our auditing experts.  Regulatory authorities are working through backlogs and companies need to be prepared for inspections.  Our team of ex-regulators and experienced consultants can assist you. Contact us by clicking here.

Author Bio

Sanjay Shetgar

Sanjay Shetgar is Vice President of Pharmaceutical Services with NSF International. He has over 30 years of pharmaceutical management experience in both plant operations and corporate offices, working with Cipla, Dr.Reddy’s and Wockhardt in India. He has held senior positions as Vice President, Head Global Corporate Quality and Senior Vice President, Head Operations Quality with Dr.Reddy’s and Wockhardt.   His experience includes API & Intermediates, various Drug Product forms including Biologics.

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