STANDARD OPERATING PROCEDURE VALIDATION- GENERAL

STANDARD OPERATING PROCEDURE

SUBJECT :                                             VALIDATION- GENERAL

DEPARTMENT         : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : Version No                  :

1.0       OBJECTIVE:

            This SOP defines the general requirements of validation.

            The purpose of validation is to assure that key products, systems, procedures, and equipment      

            function properly and are capable of achieving the desired results.  The intent of investing in           

            validation is to prevent rework and maximize quality, efficiency and cost savings by          

            proactively checking performance of key products, systems, procedures and equipment.

2.0       SCOPE:

2.1       This procedure applies to all categories, whether regulated or not. 

2.2              Key systems, procedures and equipment are those which are used for manufacturing product for human use, that have a significant impact on quality of product made for human use, or which impact product release decisions or design/development decisions.  These must be validated:

2.2.1     Equipment / Instrument qualification (IQ, OQ and PQ).

2.2.2     Cleaning validation

2.2.3     Process validation

2.2.4     Water system validation

2.2.5     HVAC system validation

2.2.6     Analytical method validation if developed Inhouse.

2.2.7    Equipment used for routinely making/packing the product

2.2.8    Cleaning & Sanitization Procedures for microbial sensitive products

             This procedure applies to new and existing products, systems, procedures and equipment.

All process validations, cleaning validation, analytical method validation & Cleaning & Sanitization validation are planned on the requirements of the principal company. Principal company supports with the documentation which need to be executed by elegant team for approval of principal company. Validation details are notified to customers for information. Utility validations like HVAC, water system are done Inhouse or with the help of outside agency and reports maintained.

2.3               Any validation must be sufficiently thorough and data-based to give an expert in the field   

confidence that the product, system, procedure or equipment is reliable.

2.4       Elegant performs water system validation, HVAC validation, cleaning validation all other validation are performed based on product principal company requirements.

3.0        PROCEDURE:

3.1       Master Validation Plan

             Production manager is responsible for developing and maintaining a Master Validation plan of              

            items requiring validation.  The list must include the following:

3.1.1        A list (by location) of all key products, systems, procedures and equipment (as defined in the           

policy) that require validation.

3.1.2        Date validation complete, or forecast date of completion.

3.1.3     Validation owners responsible for conducting validations and keeping them current.

3.1.4     Validation method used/to be used (Prospective, Concurrent, or Retrospective).

3.2       Master Validation List Review

             Each department or module will periodically review (at least annually) the Master Validation              

             List to ensure it is current and that all validations are up-to-date.  Plans will be established

             to complete validations in a timely manner.

3.3       Review and Approvals

              Validation Protocols must be reviewed and approved by the appropriate QA owner or their     

              designates. This requirement also applies to Qualification plans, EO plans, and plant test

             plans that are used to demonstrate validation.

            The conclusion on whether or not validation has been demonstrated must be reviewed and approved by the appropriate QA owner or their designates.

3.4       Executing Validation

Validation is the process used to assure that key products, systems, procedures, and equipment function as intended Validation includes:

3.4.1    Developing the validation protocol (a plan to evaluate the product, system, procedure or equipment).

3.4.2    Conducting the validation (executing the validation test).

3.4.3    Analyzing the results and gaining review/approval of the conclusions.

3.5       Developing the Validation Protocol

The Validation Protocol contains the following elements:

3.5.1    Objective - the reason for doing the validation and the type of validation method selected, whether retrospective, concurrent or prospective.

3.5.2    Scope - defines what is included (and not included) in the validation.

3.5.3    Description of the item to be validated, sufficient to understand the context and scope of the validation.

3.5.4    Background - information for perspective to assist in understanding the specific details included in the protocol, such as the design criteria for the item to be validated.

3.5.5    Success criteria for the study.  (Concurrent validations should separately reflect test-product release criteria.)

3.5.6    Responsibilities of individuals should be designated and defined particularly for complex projects where teams are large.

3.5.7    The plan of the study should describe:  special testing requirements and methods, a sampling plan, any special security or backup requirements, the length of run or number of iterations from which to gather data.

The Validation Protocol must be reviewed and approved by the department or module QA owner or their designated representative. This review is to ensure that the validation plan is sufficient to demonstrate that the product, system, procedure or equipment is functioning as intended and that it is adequate to meet QA requirements.

3.6       Conducting the Validation

Conduct the validation in accordance with the approved validation protocol.  Changes to the protocol should be reviewed with and approved by the QA representative to ensure that modifications to the plan don't render the protocol inadequate.

3.7       Analyzing the Results

Compare the results against the success criteria contained in the Protocol.

            If results meet criteria, the product, system, procedure or equipment is acceptable.

            If results do not meet criteria, two possibilities typically exist:

3.1.1        The product, system, procedure or equipment is not acceptable. Corrections must be made and additional data collected for another attempt at validation.

3.7.2    Review of the data may indicate the outages are not significant, or can be assigned to a known cause that has been corrected. In this case the product, system, procedure or equipment may be acceptable. QA must concur with accepting any discrepancies between initial success criteria and final conclusions.

The appropriate QA owner or designated representative must review and approve the determination that the Protocol indicates that the product, system, procedure or equipment is validated.

3.2              Analytical method validation.

3.8.1    Whenever a new product is manufactured analytical method is to be validated if the method is developed Inhouse.

3.8.2    In case of loan license products validated method will be furnished by the party.

3.8.3    The ruggedness of the method is checked. In case the method is to be validated then the performance characteristics of the method should meet the requirements for the intended analytical application. Performance characteristics are expressed in terms of analytical parameters.

Typical analytical parameters used in Assay validation are:

3.8.3.1             Accuracy                                

3.8.3.2 Precision

3.8.3.3             Specificity                              

3.8.3.4 Limit of detection

3.8.3.5 Limit of quantization  

3.8.3.6 Linearity

3.8.4    In case of validated method, verification of analytical method is done and the RSD of results obtained should be less than 2%.

3.9       Documentation

The validation report must include a copy or referral to the validation protocol, test results, analysis and review/approval of the conclusions.  The work must be properly documented to be considered a validation.

A record of validation will be maintained for all items listed on the Master Validation List.  Each organization must establish systems which define distribution of validation reports, to assure that information is shared appropriately to system users.

Records, including reference information, will be maintained for a minimum of 2 years beyond the last use of the product, system, procedure or equipment covered by this validation.  Individual business needs such as patent requirements or future re-applicability, may justify longer, even permanent, retention.  Validation records, including referenced information, must be retrievable within 2 business days upon request.

3.10     Revalidation needs to be done once in 3 years or in event of any major repair.

4.0       FREQUENCY: Whenever system is updated/Validation carried out.

5.0       RESPONSIBILITY: Production Manager, Maintenance Manager, Production Executives, QA Executives G.M Q.A

Each department (Tech Center) or module (plant) must maintain a Master Validation List of items requiring validation, and manage against this list to keep validations current.

6.0       REVIEW GUIDE:  Validation files.

7.0       ANNEXURE:

            1. Validation master plan.

            2. Installation qualification/operational qualification protocol.

8.0       SOPs DISTRIBUTION:

           This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	√
Warehouse	x	x
General	x	x
Maintenance	x	√