SL3313-100-Frame Page 3 Thursday, November 15, 2001 1:43 PM

100.10  Validation Standard Operating Procedures  3

YOUR COMPANY
VALIDATION STANDARD OPERATING PROCEDURE

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

Approved by:

TITLE: Introduction to Validation

AUTHOR: ________________________________________
Name/Title/Department

________________________________________
Signature/Date

CHECKED BY: ________________________________________

Name/Title/Department

________________________________________
Signature/Date

APPROVED BY: ________________________________________

Name/Title/Department

________________________________________
Signature/Date

REVISIONS:

No. Section Pages Initials/Date

SL3313-100-Frame Page 4 Thursday, November 15, 2001 1:43 PM

4  Validation Standard Operating Procedures  100.10

SOP No. Val. 100.10 Effective 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 param-
eters, 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 com-
pleted and the results are approved prior to any product release.