Process Validation Sample Protocol

1.0 Protocol Approval:

Signing of this approval page of Process Validation Protocol No. __________ indicates agreement with the Process Validation approach described in this document. Any modifications to the Process Validation will be prepared and approved as an addendum.

2.0 Objective:

To conduct the process validation of the manufacturing process for the _____________ manufactured at the liquid facility. The validation study shall be conducted for the generation of sufficient data to establish documentary evidence and to provide assurance that the product can be manufactured on a commercial scale, meeting all its quality attributes in a consistent manner.

Three consecutive commercial batches of ___________ shall be taken for process validation.

3.0 Scope:

This protocol shall be applicable for first three consecutive commercial scale batches manufactured with specific batch size & equipment and operating parameters for the _____________ at ABC Limited.

4.0 Validation Approach:

The validation approach shall be prospective and following things shall be reviewed:

4.1 Review the qualification documents of equipment and related utility systems which shall be employed for the manufacturing of batch.

4.2 Review the calibration record of instruments used in validation. 

4.3 Review the master formula records.

4.4 Review the specification and analytical procedures of raw materials and packing materials.

4.5 Review the specification and analytical procedures for in-process & finished products.

5.0 Reason for Validation: New product in the manufacturing facility.

6.0 Revalidation: Revalidation shall be done in case of following cases:

6.1 Any major change in the manufacturing process which may affect the quality of the product.

6.2 Any change in the batch size

6.3 Any change in the batch formula

6.4 Change in manufacturing site

6.5 Any modification in any critical equipment

6.6 Any major modification in the related utility system

6.7 Any change in the specification and/or change in the source of active pharmaceutical ingredient (API)

6.8 Any change in primary packaging material.

7.0 Responsibilities:

7.1 Quality Assurance shall be responsible for:

7.1.1 Preparation, approval and training of validation protocol, review of the data compiled, review of deviations (if any), monitoring the process as per the process parameters and for withdrawal of validation samples.

7.1.2 Review of facility, equipment qualification and utility validation reports.

7.1.3 cGMP compliance during the manufacturing process, review and evaluation of the data/results generated during the validation process.

7.1.4 Preparation of process validation summary report, review and its approval.

7.2 Production shall be responsible for:

7.2.1 To execute the batches as per the batch production record and process validation protocol.

7.2.2 Compilation of data related to manufacturing area and furnishing the same for review.

7.2.3 Review of protocol and summary report.

7.3 Quality Control shall be responsible for:

7.3.1 Raw material and packing material analysis

7.3.2 In process and finished product samples analysis as per the sampling plan.

7.3.3 Collection and review of in process and finished product analysis data.

7.3.4 Submission of data /results to QA for review and evaluation.

8.0 Reference Documents:

8.1 BMR No:

8.2 BPR No:

8.3 Specification No.:

9.0 Procedure:

9.1 Product Details:

PRODUCT NAME	:
GENERIC NAME	:
SHELF LIFE	:
STORAGE CONDETION	:
LABEL CLAIM	:
OVERAGES (IF ANY)	:
BATCH SIZE	:
MARKET	:
PACKING INSTRUCTION	:

9.2 Raw Material Details:

Item code	Ingredient	Grade	Quantity Batch ( Kg)

9.3 Packing Material Details:

Item code	Ingredient	Unit	Std. Quantity /Batch

9.4 Equipment Details:

Sr. No.	Ingredient	Equipment Code

9.5 Quality Control Instruments:

Sr. No.	Instrument Name	Instrument Code

9.6 Manufacturing Process Flow Chart: Diagrammatic flow chart for the manufacturing process of the product.

9.7 In-process Checks & Critical Control Points:

Sr. No.	Process	Parameters

9.8 Sampling Plan & Acceptance Criteria:

Stage	Sampling Location & Quantity	Test	Acceptance Criteria

9.9 Finished Product Specification:

Sr. No.	Test	Limit

10.0 Sampling Plan Diagram: Prepare a diagram representing the sampling location.

11.0 Stability: If acceptance criteria at all the stages of 3 batches are satisfied, the process to be accepted as validated for manufacturing the product at the site, ABC Limited. The Validation batches shall be introduced for complete stability studies as per stability protocol.

12.0 Deviations: Any deviation from the protocol related to the manufacturing process, raw materials, equipment used, sampling, in-process controls and analytical methods should be authorized and documented in the batch manufacturing record as well as the validation report.

13.0 Conclusion: Based on the results of all the 3 batches, suitable conclusions will be drawn with respect to the suitability of proposed method of manufacture for the ____________. Conclusion about the suitability of the validation batches for stability testing would be drawn.

14.0 Documentation and Reporting: Validation protocol, batch manufacturing records, batch packing records, analytical reports,  stability protocol, stability data and stability report of all the three validation batches have to be compiled, reviewed and to be documented.  A process validation report shall be prepared.

15.0 Report Approval: Process validation data shall be compiled and report shall be prepared by Officer or Executive – QA. The report shall be checked by Asst. Manager – QA, Manager – QC, Manager-Production and shall be approved by DGM – Quality.

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