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Process Validation Sample Protocol

This document provides a template for a process validation protocol. It outlines the objectives, scope, validation approach, responsibilities, procedures, sampling plans, acceptance criteria, and documentation requirements for validating a pharmaceutical manufacturing process. The protocol calls for prospectively validating the process for a new product using three consecutive commercial-scale batches. Data from raw materials, in-process checks, finished product testing and stability testing will be collected and reviewed to ensure the process consistently produces product meeting specifications. A process validation report summarizing the results will be prepared for approval.

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Bilal Masood
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2K views

Process Validation Sample Protocol

This document provides a template for a process validation protocol. It outlines the objectives, scope, validation approach, responsibilities, procedures, sampling plans, acceptance criteria, and documentation requirements for validating a pharmaceutical manufacturing process. The protocol calls for prospectively validating the process for a new product using three consecutive commercial-scale batches. Data from raw materials, in-process checks, finished product testing and stability testing will be collected and reviewed to ensure the process consistently produces product meeting specifications. A process validation report summarizing the results will be prepared for approval.

Uploaded by

Bilal Masood
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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
Comments so far

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
reviewed:
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.
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 manufacturing process, review and evaluation
of the data/results generated during 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 Quantity Batch (
Ingredient Grade
code Kg)

9.3 Packing Material Details:


Item Ingredient Unit Std. Quantity /Batch
code
9.4 Equipment Details:
Sr.
Ingredient Equipment Code
No.

9.5 Quality Control Instruments:


Sr.
Instrument Name Instrument Code
No.

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.
Process Parameters
No.

9.8 Sampling Plan & Acceptance Criteria:


Stag Sampling Location &
Test Acceptance Criteria
e Quantity

9.9 Finished Product Specification:


Sr.
Test Limit
No.

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 manufacturing
process, raw materials, equipments 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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