Professional Documents
Culture Documents
Process Validation Sample Protocol - Pharmaguideline
Process Validation Sample Protocol - Pharmaguideline
-->
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.
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.
https://www.pharmaguideline.com/2013/11/process-validation-sample-protocol.html 1/3
1/3/23, 4:54 PM Process Validation Sample Protocol : Pharmaguideline
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 :
9.6 Manufacturing Process Flow Chart: Diagrammatic flow chart for the manufacturing process of the product.
https://www.pharmaguideline.com/2013/11/process-validation-sample-protocol.html 2/3
1/3/23, 4:54 PM Process Validation Sample Protocol : Pharmaguideline
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.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical
blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Need Help: Ask Question
Copyright © 2008-2023 Pharmaguideline
Setup ❘ Terms of Use ❘ FAQ
https://www.pharmaguideline.com/2013/11/process-validation-sample-protocol.html 3/3