1.0 PURPOSE

1.1 To lay down a general policy on validation of specific methods/systems in order to provide high degree of assurance that the defined method/system can deliver the product to predetermined quality consistently.

2.0 SCOPE

This policy is applicable for all the validation activities to be performed at various departments.

3.0 RESPONSIBILITY

3.1 Respective department Heads are responsible to carry out the validations for the respective activities.

3.2 Head-QA is responsible to co-ordinate and ensure that the validations are carried out as per the defined procedures.

4.0 DEFINITION

4.1 According to GMP definition Validation is “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.”

5.0 PROCEDURE

5.1 All the key methods/systems in the quality systems which are critical to quality of the finished product shall be validated. No critical equipment / system, utility process or method shall be used without validation.

5.2 Validation shall extent to the operations determined to be critical to the quality and purity of the drug substance.

5.3 Following elements of the quality system shall consider for validation.

5.3.1 Manufacturing process of API

5.3.1.1 The process validation is classified as

             Prospective

            Concurrent

            Retrospective

5.3.1.2 The criteria for selection of the validation category are discussed in detail in the respective SOPs.

5.3.1.3 All process validation activities shall perform as per the pre-defined approved protocol and the results/observations shall be recorded in the respective reports. All batches under process validation shall monitor by stability studies.

5.3.2 Analytical Methods: Validation of analytical methods shall include the following criteria.

         Linearity

         System suitability

         Specificity

         Accuracy

         Precision (System precision, Intermediate precision)

         Range

         Limit of detection

         Limit of quantification

         Robustness

5.3.3 Key equipment: The qualification activities shall perform as per predefined approved protocols and the reports shall summarize the observations and results in IQ, OQ and PQ.

5.3.4 Cleaning procedure: The cleaning validation studies shall establish the effectiveness of the cleaning procedure described in the respective cleaning records, all cleaning validation activities shall carried out as per predefined approved protocol with well-defined acceptance criteria as per the current regulatory guidelines and the results shall record in the report.

5.3.5 Air handling system in the critical areas: Air handling system shall be qualified to ensure proper pressure gradient and airflow pattern are maintained in the critical areas, this shall include a proper design qualification followed by IQ, OQ and PQ in support of the design.

5.3.6 Purified water system: The water to be used in the manufacturing process is to be qualified in the Phase manner which should comply with the regulatory requirement.

5.3.7 Re-validation: If any changes are proposed to the existing validated equipment/ system/ process/ method scientific justification shall applied to determine the additional testing and scope of revalidation.

5.4 Any areas other than mentioned above may be considered for validation if required.

5.5 Based on the validation policy, validation Master Plan shall be prepared describing various elements to be validated, responsible personnel for executing the activity, the sequence and schedule of different validations to be carried out , the re validation criteria for each element of the quality system shall be described.

5.6 Approved protocols shall be prepared for all validation activities indicating the objective, responsibility, procedures and results recorded in the reports with comments on any deviation observed and drawing appropriate conclusions, including recommending changes to correct deficiencies.

5.7 Any deviation from the validation protocol shall be documented with appropriate justification.

5.8 All validation protocols and reports shall be approved by the Head-QA.

5.9 Before initiating the process or analytical method validation activity appropriate qualification of critical equipment and ancillary system shall be completed.

5.10 Equipment and process shall periodically evaluated to verify that they are still operating in a valid manner. Where no significant change has been made to the equipment or process and the quality review confirms that the equipment or process is consistently producing material meeting its specifications, there is no need for re validation.

5.11 Concurrent validation is often the appropriate validation approach for rework procedures. However, for single reworked batch a report can be written and batch can be released only after the stability data for a defined period is found to comply the predefined acceptance criteria

6.0 ABBREVIATIONS

6.1 QA –Quality Assurance

6.2 GMP –Good Manufacturing Practice

6.3 API –Active Pharmaceutical Ingredient

6.4 IQ –Installation Qualification

6.5 OQ –Operational Qualification

6.6 PQ –Performance Qualification

7.0 ANNEXURES

7.1 NIL

END OF THE DOCUMENT