SECTION

VAL 100.00

100.10

YOUR COMPANY VALIDATION STANDARD OPERATING PROCEDURE

SOP No. Val. 100.10Effective date: mm/dd/yyyy Approved by:

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Introduction to Validation __________________________________________

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REVISIONS:
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SOP No. Val. 100.10Effective date: mm/dd/yyyy Approved by:

SUBJECT: Introduction to Validation PURPOSE

To describe the definition, types, and benefits of validation

RESPONSIBILITY
It is the responsibility of validation team members to follow the procedures. The quality assurance (QA) manager is responsible for SOP compliance.

PROCEDURE
1. Definition of Validation
Validation is a systematic approach to gathering and analyzing sufficient data which will give reasonable assurance (documented evidence), based upon scientific judgment, that a process, when operating within specified parameters, will consistently produce results within predetermined specifications.

2. Type of Validation
Retrospective Validation Prospective Validation Concurrent Validation Revalidation

2.1 Retrospective Validation

Validation of a process for a product already in distribution, based on accumulated production, testing, and control dates. Summary of existing historical data.

2.2 Prospective Validation

Validation conducted prior to distribution either of a new product, or a product made under a revised manufacturing process. Validation is completed and the results are approved prior to any product release.

SOP No. Val. 100.10Effective date: mm/dd/yyyy Approved by:

2.3 Concurrent Validation

A combination of retrospective and prospective validation. Performed against an approved protocol but product is released on a lot-by-lot basis. Usually used on an existing product not previously validated or insufficiently validated.

2.4 Revalidation
To validate change in equipment, packaging, formulation operating procedure, or process that could impact product safety, efficacy, or potency. It is important to establish a revalidation program for critical equipment to maintain validity.

3. Importance of Validation
Increased throughput Reduction in rejections and reworking Reduction in utility costs Avoidance of capital expenditures Fewer complaints about process-related failures Reduced testing in-process and in finished goods More rapid and reliable start-up of new equipment Easier scale-up from development work Easier maintenance of equipment Improved employee awareness of processes More rapid automation

REASONS FOR REVISION

Effective date: mm/dd/yyyy First time issued for your company, affiliates and contract manufacturers