Question: Match the concepts. Process Performance Qualification Validation Process Validation Installation Qualification (IQ) Validation Protocol Product Performance Qualification Prospective Validation Retrospective Validation a. Conducted prior to

Match the concepts.

Process Performance Qualification

Validation

Process Validation

Installation Qualification (IQ)

Validation Protocol

Product Performance Qualification

Prospective Validation

Retrospective Validation

a.

Conducted prior to the distribution of the product.

b.

Confirmation by examination and provision of objective evidence that a particular requirement for a intended use can be consistently fulfilled.

c.

Establishing documented evidence that the process is effective and reproducible.

d.

Establishing documented evidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.

e.

Establishing documented evidence through appropriate testing that the finished product produced by a specific process(es) meets all release requirements for functionality and safety.

f.

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

g.

Process for a product already in distribution.

h.

Written plan stating how validation will be conducted.

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