Question: What is concurrent validation in pharma?

Concurrent validation is used for establishing documented evidence that a facility and processes do what they purport to do, based on information generated during actual imputation of the process.

What is concurrent validation in pharmaceutical industry?

Concurrent validation is used to establish documented evidence that a facility and process will perform as they are intended, based on information generated during actual use of the process.

What is difference between prospective and concurrent validation?

The Difference Between Prospective, Concurrent and Retrospective Validation. Prospective validation occurs before the system is used in production, concurrent validation occurs simultaneously with production, and retrospective validation occurs after production use has occurred.

What is retrospective validation in pharma?

Retrospective process validation is validation of a process for a product already in distribution based upon accumulated production, testing and control data. The validation program must be planned and documented, and the validation results must be documented and maintained.

What is validation and its types?

The guidelines on general principles of process validation mentions four types of validation: A) Prospective validation (or premarket validation) B) Retrospective validation. C) Concurrent validation. D) Revalidation.

What is the process validation in pharma?

For purposes of this guidance, process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

What is validation and types?

The guidelines on general principles of process validation mentions four types of validation: A) Prospective validation (or premarket validation) B) Retrospective validation. C) Concurrent validation. D) Revalidation.

What is the incident in pharma?

Incident or incidence: an unplanned event that exceeds limits, specifications or expectations. Deviation or deviate: a planned event required due to an unforeseen issue that is meant to keep control of the process/product but which does not follow standard operating practices/procedures.

What is IQ OQ PQ in pharma?

The meaning of IQ, OQ and PQ are installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment.

Join us

Find us at the office

Quadrino- Battice street no. 14, 40027 Taipei, Republic of China (Taiwan)

Give us a ring

Kedrick Wodzisz
+12 699 726 918
Mon - Fri, 11:00-16:00

Contact us