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OREO Chocolate Chip Cookies Inc.

Name of
Document:
Document
Version:
Location:
Document#
Written By:
Checked By:
Approved By:

Process Validation Protocol

0.0.01

Effective Date:

EAS 201
DM 021
Name: Parina Kothari
Signature:
Name: Krupa Patel
Signature:
Name: Rajan Ramanuj
Signature:

Valid for 2 Years

Replaces: N/A
Position: Validation Engineer

Date:

Position: Project Engineer

Date:

Position: QA Engineer

Date:

Written By: Your signature indicates that this document has been prepared in accordance with existing
project standards and adequately reflects the tasks and deliverables as per regulatory
requirements for Process Validation Protocol.

Checked By: Your signature indicates that you have read and reviewed Process Validation Protocol
document and that it accurately and completely reflects the tasks and deliverables necessary
for Process Validation Protocol and it follow the regulatory requirements.

Approved By: Your signature indicates that you have read and reviewed Process Validation Protocol after
completely written and checked by and authorized persons signed. You checked that
document is followed and fulfilled the regulatory requirements. You are the responsible to
approve this document.

Revision History:
Revision#
N/A

Revision Date
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Reason for Revision

N/A

Document Name: Process Validation Protocol

Document# DM 021

Revised by
N/A

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Contents
1 Purpose
2 Scope
3 Responsibilities
4 Supporting Documents
5 Validation Parameters
6 Critical Parameters
7 Product and Raw Material Information
8 Process Flow Diagram
9 Manufacturing Process
10 Critical Process Parameters
11 Process Validation Tests (Attachments template)
Attachment 1: Blending/Mixing Uniformity
Attachment 2: Content Uniformity Test
Attachment 3: Weight Variation Test
Attachment 4: Hardness Test
Attachment 5: Color Test
Attachment 6: Deviation Report
12 Process Validation Summary

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1. PURPOSE:
The purpose of this process validation protocol is to demonstrate that Oreo Chocolate Chips
Inc. manufacturing can consistently produce Chocolate chips cookies (333gms) that meet
the predetermined acceptance criteria and other predetermined specifications consistently.

2. SCOPE:
The provisions of this validation protocol apply to the manufacturing process of chocolate
chips cookies. The protocol will use three commercial scale lot prospective validations to
qualify that the manufacturing process for chocolate chips produces product of acceptable
quality at Oreo manufacturing facility.

3. RESPONSIBILITIES:
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1. Quality Assurance

Review and approve protocol

Perform a final review of the documents to ensure overall compliance

Review and approve final report

2. Process Development Scientist

Prepare the SOP.

Prepare Batch Record.

Prepare bills of materials

Prepare process flow diagram

Prepare process development data.

3. Validation Engineer:

Prepare the protocol with all the operational validated ranges of the equipment

Provide the equipment and utility qualification information

Prepare and route the final reports for approvals

4. Project manager:

Supervise the overall process

Act as per timeline

Report to VP of Operations

5. Project Engineer:

Prepare equipment specification and list of equipment.

Participate to prepare the SOP.

Prepare the qualification protocols IQ and OQ.

6. Laboratory Supervisor:

Prepare SOPs
Perform Laboratory work
Perform all the Testing/analysis.
Maintain GMP environment in the Manufacturing Unit.

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Assist in Test execution.

4. SUPPORTING DOCUMENTATION:

1. PROTOCOL ATTACHMENT:

Premixing sampling and analysis record.

Blend uniformity sampling record

Laboratory reports

FMEA

2. REPORT ATTACHMENTS:

STATISTICAL ANALYSIS REPORT

5. VALIDATION PARAMETERS:

The Validation modifications encompassed by this protocol include increase in the batch
size from the initial trail batches as well as modifications of operational parameters to
accommodate change in batch size. Equipment used is the same in the operational principle
as that employed for prior trail batches for FMEA of this product. Parameters that can
impact the manufacturing process are identified below:

Process
Weighing

Parameters

As per batch records

GRANULATION
Pre blending (Wheat Flour + Salt +
Mix at 2 RPM for 5 min
Baking Soda)
Margarine + Brown sugar + White sugar Mix at 8 RPM for 50 seconds
Add apple sauce& vanilla extract
Mix at 8 RPM for 45 seconds
Scrap it with spatula
Wet mixing
Mix at 8 RPM for 2 minutes
Add chocolate chips
Mix at 8 RPM for 1minute
Sampling for Batch Uniformity
Uniform conductivity
BAKING
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Preheating oven
Online metronome 60
Baking
Cooling

220 F
for 15 counts
220 F for 10 mins.
At room temperature for 10 minutes.

6. CRITICAL PARAMETERS:
Critical parameters in granulation process:
1. Order of addition of Flour
2.Flow properties of Flour
3.Size distribution of Flour Particles
4.Environmental Humidity
5.Environmental Temperatures
Critical parameters of baking process:
7. Baking temperature
8. Time of baking
9. Cooling rate
10. Room conditions while cooling.

7.

PRODUCT AND RAW MATERIAL INFORMATION:

INGREDIENTS
All Purpose flour
Salt
Sodium bicarbonate
Brown sugar
White sugar
Margarine

QUANTITY IN GRAMS
300
2.5
2.5
60
120
100

Applesauce

120

Vanilla Extract
Semi sweet chocolate
chips

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90

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8.

PROCESS FLOW DIAGRAM:

9.

Manufacturing Process:

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OREO Manufacturer will produce chocolate chip cookies by following the standard operating
procedure for overall manufacturing of a batch. For Standard operating procedures, refer different
SOPs for each operation.

10.Critical Process Parameters:

The OREO Manufacturer will use the risk based approach in the manufacturing of the chocolate
chip cookies. Risk assessment consists of the identification of the out of specification results or
variability and the analysis and evaluation of the risk associated with it. The out of specification
results can fail the batch so by controlling the critical parameters, product will meet the
specification.
FMEA tool is used to prioritize risks and monitor the effectiveness of risk control activities and also
identify different critical process parameters which are responsible for the variability in the
chocolate chip cookies. By controlling these parameters, it makes possible to manufacturer cookies
with the acceptance criteria. For the FMEA document, refer document FMEA.

11.Process Validation Test:

Systemic testing is the most important part for verification process which demonstrates that process
consistently produces the product according to its intended use. Following are Quality control tests
which are performed during production and after production to determine quality of the finished
chocolate chip cookies.

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Validation Batch Record

Validation Batch#
Date:

Performed By:

Approved By:

Name:

Name:

Position:

Position:

Signature:

Signature:

Date:

Date:

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Attachment 1: Blending / Mixing Uniformity Test

The effectiveness of HBD is directly related to NaCl content in the final product. Therefore the
blend uniformity of the pre blend is critical. For proper mixing, refer SOP for the mixing and follow
the procedure to achieve proper blending operation.
Procedure:
Mix all ingredients according to the procedure and take sample from top, middle and bottom with
help of the sample thief and record the weight. Add 50 ml of water and mix it. Determine the
conductivity of the solution using a conductivity meter. Determine the %RSD.
Acceptance criteria:

The 3 final Blend Uniformity samples must be 85 115% of Target.

The RSD of the final Blend Uniformity (BU) samples must be <6.0%.

Sampling
Site

SET1
Weight

Conductivity
of
BU%

SET2
WEIGHT

Conductivity
of
BU%

SET3
WEIGHT

Conductivity
of
BU%

1
2
3
4
5
6
MEAN
STD DEV.
%RSD

MEAN
STD DEV.
%RSD

MEAN
STD DEV.
%RSD

Comments:
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__________________________________________________________________________
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Test Status (Pass or Fail):
Performed By: Validation Engineer
Reviewed By: QA Engineer

Date:
Date:

Attachment 2: Content Uniformity Test

The efficacy of HBD is directly related to content uniformity of Chocolate chips in the final product
dose. Therefore the content uniformity test is very critical.
Procedure:
Select 10 chocolate chip cookies randomly from each batch. Place them in the container and add
desired amount of water in at and dissolve it for the time mentioned. Filter the solution through a
screen to collect the chocolate chips. The chocolate chips are them dried and weighed and the
chocolate chip content of cookies can be determined.
Acceptance Criteria:

The chocolate chip cookies must be 50.5 grams of chocolate chips.

%RSD must be <or= 6.00%

BATCH 1:
SAMPLE NO
1
2
3
4
5
6
7
8
9
10

NO. OF CHOCOLATE CHIPS RETAINED

% CONTENT UNIFORMITY

Comments:
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Test Status (Pass or Fail):
Performed By: Validation Engineer
Reviewed By: QA Engineer
Attachment 3: Weight Variation Test

Date:
Date:

Note: The finished chocolate chip cookies must be 33 3 gm.

Procedure:
Select 10 finished chocolate chip cookies randomly from the batch and weigh it. Record the
individual weight of the cookies and report it in the data sheet.
Acceptance criteria:

All cookies weight must be 33 3 grams. Out of 10, if one is out of specification then repeat
a test and 2 or more then test fails.
Sr. no.

Wt of parchment
paper

Wt of cookie with
parchment paper

Wt of cookie

1
2
3
4
5
6
7
8
9
10
Comments:
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Test Status (Pass or Fail):

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Performed By: Validation Engineer

Reviewed By: QA Engineer

Date:
Date:

Attachment 4: Hardness Test

The finished chocolate chip cookies should be hard enough that can break it from the middle and
not too soft. The soft cookies indicate that it is not well cooked and too hard indicated that it is over
cooked.
Procedure:
Select 5 cookies randomly from the batch and perform the hardness test by simply breaking cookies
from the middle.
Acceptance Criteria:

Out of 5 cookies, 4 cookies must pass the test.

No. of Sample

Observation

Result

1
2
3
4
5

Comments:
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Test Status (Pass or Fail):

Performed By: Validation Engineer
Reviewed By: QA Engineer

Date:
Date:

Attachment 5: Color Test

The finished chocolate chip cookies should have a good brownish color. A brownish color is an
indication of well-cooked cookies whereas dark brownish black color is an indication of overcooked
and a light brownish color is an indication of not cooked.
Procedure:
Select 5 cookies randomly from the batch and perform visual inspection for the test.
Acceptance Criteria:

Out of 5 cookies, 4 cookies must pass the test.

No. of Sample

Observation

Result

1
2
3
4
5

Comments:
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Test Status (Pass or Fail):

Performed By: Validation Engineer
Reviewed By: QA Engineer

Date:
Date:

Attachment 6: Deviation Report

Document every deviation founded during execution of this protocol in this form. Report every
investigation made following the deviation with detail of corrective action that being taken. Sign the
report as it done as intended.
Deviation# _____
Description
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Corrective Action Taken

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Satisfactorily Completed? (Y/N): ______

Performed By: __________________

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Date: ______________

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Approved By: ___________________

Date: ______________

12. Final Validation Summary Report :

Validation Summary Report:

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Comment:
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Written By: Validation Engineer

Reviewed By: QA Engineer

Document Name: Process Validation Protocol

Document# DM 021

Date:
Date: