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Process Validation Sample Protocol

Process validation protocol template or format for the products
manufactured in the pharmaceutical product manufacturing facility. It is a
example for the validation protocol.
Ankur Choudhary | Protocol | Quality Assurance | Validation | Print | Question Forum 3
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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 & equipments and operating
parameters for the _____________ at ABC Limited.
4.0 Validation Approach:
The validation approach shall be prospective and following things shall be
4.1 Review the qualification documents of equipments 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.

0 Reference Documents: 8.3.3 Any change in the batch formula 6. 7. 7. equipment qualification and utility validation reports.3.1 To execute the batches as per the batch production record and process validation protocol. 6.: .7 Any change in the specification and/or change in the source of active pharmaceutical ingredient (API) 6.2 Compilation of data related to manufacturing area and furnishing the same for review.1.1. 7. 7.3.1 Any major change in the manufacturing process which may affect the quality of the product.4 Preparation of process validation summary report.4 Change in manufacturing site 6.8 Any change in primary packaging material.1 BMR No: 8.0 Responsibilities: Submission of data /results to QA for review and evaluation.2 In process and finished product samples analysis as per the sampling plan.2 BPR No: 8.3 Quality Control shall be responsible for: 7. review and its approval.5 Any modification in any critical equipment 6.3 Review of protocol and summary report.2 Any change in the batch size 6.2 Review of facility. 7. review of deviations (if any). 7.1 Raw material and packing material analysis 7. review and evaluation of the data/results generated during validation process. approval and training of validation protocol.2.2 Production shall be responsible for: 7.1. 7.3 Specification No.2. 6. 8.1.3 cGMP compliance during manufacturing process.1 Preparation. 7. review of the data compiled.1 Quality Assurance shall be responsible for: 7.6 Any major modification in the related utility system 6.5. 7. 7.0 Revalidation: Revalidation shall be done in case of following cases: 6.0 Reason for Validation: New product in the manufacturing facility. monitoring the process as per the process parameters and for withdrawal of validation samples.3 Collection and review of in process and finished product analysis data.

3 Packing Material Details: Item Ingredient Unit Std.1 Product Details: PRODUCT NAME : GENERIC NAME : SHELF LIFE : STORAGE : CONDETION LABEL CLAIM : OVERAGES (IF ANY) : BATCH SIZE : MARKET : PACKING : INSTRUCTION 9.0 Procedure: 9.9. Quantity /Batch code .2 Raw Material Details: Item Quantity Batch ( Ingredient Grade code Kg) 9.

Instrument Name Instrument Code No. 9. Ingredient Equipment Code No.4 Equipment Details: Sr. 9.8 Sampling Plan & Acceptance Criteria: Stag Sampling Location & Test Acceptance Criteria e Quantity 9.5 Quality Control Instruments: Sr.9.9 Finished Product Specification: .7 In-process Checks & Critical Control Points: Sr. Process Parameters No. 9.6 Manufacturing Process Flow Chart: Diagrammatic flow chart for the manufacturing process of the product. 9.

0 Documentation and Reporting: Validation protocol. the process to be accepted as validated for manufacturing the product at the site.0 Report Approval: Process validation data shall be compiled and report shall be prepared by Officer or Executive – QA. stability data and stability report of all the three validation batches have to be compiled. Test Limit No. 14. 10. A process validation report shall be prepared.0 Deviations: Any deviation from the protocol related to manufacturing process. 11. batch manufacturing records. suitable conclusions will be drawn with respect to the suitability of proposed method of manufacture for the ____________. The report shall be checked by Asst. Conclusion about the suitability of the validation batches for stability testing would be drawn. in-process controls and analytical methods should be authorized and documented in the batch manufacturing record as well as the validation report. equipments used. Manager – QA. The Validation batches shall be introduced for complete stability studies as per stability protocol. . 15.0 Conclusion: Based on the results of all the 3 batches. Manager-Production and shall be approved by DGM – Quality.0 Sampling Plan Diagram: Prepare a diagram representing the sampling location. reviewed and to be documented.0 Stability: If acceptance criteria at all the stages of 3 batches are satisfied. raw materials. 13. stability protocol. batch packing records. Manager – QC.Sr. ABC Limited. sampling. analytical reports. 12.