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What is the difference between audit and inspection in pharma?

In pharma, we distinguish between audits - either internal or third party, which look for compliance with defined standards - and inspections, which are carried out by regulatory authorities, for licensing purposes (new products or ongoing supply).

What is the difference between audit and inspection in GMP?

1) Inspections focus on what, audits focus on why This is an inspection. The second has various layers. It requires exploratory reviews involving risk assessments, training records, documentation, supplier reviews, equipment analysis, nonconformities etc. This is an audit.

What are the differences between inspection audit and evaluation?

Unlike audits and inspections which primarily focus on compliance, assessments are often more holistic, gauging the effectiveness or performance of a system, process, or individual.

What is the difference between audit and inspection in clinical research?

It is helpful to think of the Plan-Do-Check-Act (PDCA) cycle to differentiate between audits and inspections. At a high level, inspections are a do and audits are a check. An inspection is typically something that a site is required to do by a compliance obligation.

What is an audit inspection?

An audit inspection generally focuses on the audit process to make sure that auditors have conducted appropriate tests and provided adequate documentation of their conclusions.

What is the difference between inspection audit and survey?

Whether its an audit, an inspection, an assessment or a check, its most likely to take place at a location. On the contrary, surveys can take place almost anywhere. A survey refers to a questionnaire, which is targeted to a specific group of people.

What is the difference between an audit and an ISO inspection?

Inspections: Result in a report show conformity, nonconformity, or a degree of conformity; can also list found issues or potential hazards. Audits: Produce a more detailed report or findings that encompass compliance, recommendations for improvement, and potential risks. They can also result in official certification.

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