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Process-Validation - General-Principles-and-Practices-7

This document defines process validation as collecting and evaluating data from process design through commercial production to establish that a process can consistently deliver quality products. It describes process validation occurring in three stages: stage 1 involves defining the commercial process based on development; stage 2 evaluates the design's ability to reproduce commercial manufacturing; and stage 3 provides ongoing assurance during routine production that the process remains in control. Before commercial distribution, manufacturers should have a high degree of assurance the process will consistently produce products meeting specifications relating to identity, strength, quality, purity and potency, based on objective data from studies at various scales. A successful validation program depends on knowledge from product and process development to establish control over manufacturing and produce products with desired attributes.

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Kendry Jose
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50 views1 page

Process-Validation - General-Principles-and-Practices-7

This document defines process validation as collecting and evaluating data from process design through commercial production to establish that a process can consistently deliver quality products. It describes process validation occurring in three stages: stage 1 involves defining the commercial process based on development; stage 2 evaluates the design's ability to reproduce commercial manufacturing; and stage 3 provides ongoing assurance during routine production that the process remains in control. Before commercial distribution, manufacturers should have a high degree of assurance the process will consistently produce products meeting specifications relating to identity, strength, quality, purity and potency, based on objective data from studies at various scales. A successful validation program depends on knowledge from product and process development to establish control over manufacturing and produce products with desired attributes.

Uploaded by

Kendry Jose
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Contains Nonbinding Recommendations

• Each step of a manufacturing process is controlled to assure that the finished product
meets all quality attributes including specifications.

B. Approach to Process Validation

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. Process validation
involves a series of activities taking place over the lifecycle of the product and process. This
guidance describes process validation activities in three stages.

• Stage 1 – Process Design: The commercial manufacturing process is defined during this
stage based on knowledge gained through development and scale-up activities.

• Stage 2 – Process Qualification: During this stage, the process design is evaluated to
determine if the process is capable of reproducible commercial manufacturing.

• Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine


production that the process remains in a state of control.

This guidance describes activities typical of each stage, but in practice, some activities might
occur in multiple stages.

Before any batch from the process is commercially distributed for use by consumers, a
manufacturer should have gained a high degree of assurance in the performance of the
manufacturing process such that it will consistently produce APIs and drug products meeting
those attributes relating to identity, strength, quality, purity, and potency. The assurance should
be obtained from objective information and data from laboratory-, pilot-, and/or commercial-
scale studies. Information and data should demonstrate that the commercial manufacturing
process is capable of consistently producing acceptable quality products within commercial
manufacturing conditions.

A successful validation program depends upon information and knowledge from product and
process development. This knowledge and understanding is the basis for establishing an
approach to control of the manufacturing process that results in products with the desired quality
attributes. Manufacturers should:

• Understand the sources of variation


• Detect the presence and degree of variation
• Understand the impact of variation on the process and ultimately on product attributes
• Control the variation in a manner commensurate with the risk it represents to the process
and product

Each manufacturer should judge whether it has gained sufficient understanding to provide a high
degree of assurance in its manufacturing process to justify commercial distribution of the

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