Audit: ensure quality and compliance with systematic, independent examination and documented process
Inspection: determination of conformity to specified requirements
“Audit” can be seen as an umbrella term, whereas “inspection” is one concrete type of audit.
Similarities
1) Both involve a review of processes, procedures, and records.
2) Both aim to determine whether a company or organization is following established guidelines and standards.
3) Both processes are essential in maintaining high quality standards and ensuring the safety and efficacy of products.
Differences
Purpose:
1) Audits are typically conducted to evaluate the overall effectiveness of a system or process, while inspections are more focused on identifying specific deficiencies or non-compliance issues.
2) Audits tend to be more comprehensive and in-depth, while inspections may be more targeted and specific.
Frequency:
1) Audits are usually scheduled at regular intervals, while inspections may be conducted on a more ad hoc basis, such as when a regulatory agency receives a complaint or has reason to believe there may be non-compliance at a particular site.
Who conducts:
1) Audits are usually conducted by internal or external auditors who are trained and qualified in the relevant standards and regulations, on the other hand, Inspections are usually conducted by regulatory agencies or other authorized bodies.
2) Internal audits (self-inspections), external audits (customers and health agencies – 1st party, 2nd party and 3rd party audits) whereas inspection represent the highest degree of independence.
Documentation:
1) Audits typically result in a detailed report with findings and recommendations for improvement, while inspections may result in a formal report or a list of observations and deficiencies that need to be addressed.
2) Audits may also involve the development of an action plan to address any identified issues, while inspections may require immediate corrective actions to be taken.
Companies should strive to conduct regular audits and self-inspections, as well as be prepared for regulatory inspections to ensure a smooth and successful outcome. By continuously monitoring and improving processes and procedures, pharmaceutical companies can ensure the safety and efficacy of their products and maintain the trust of consumers and regulatory agencies.
Read also:
- Common Terms Used in USFDA Inspections
- FDA Compliance Guide on Pre-approval Inspections (PAI)
- Criteria of Maintaining Audit and Inspection Readiness in Pharmaceutical Industry
Resource Person: Bharathi Kodali