TEMPLATE FOR PROCESS VALIDATION PROTOCOL

CONTENTS
Point Section Title Pages
No. No.
NA Contents 1
NA Protocol Approval Sheet 2
1.0 Objective 3
2.0 Scope 3
3.0 Responsibility 3
4.0 Validation Team Members 3
5.0 Abbreviations 4
6.0 Pre-requisite for Validation 4
7.0 Manufacturing Procedure Under 6
Validation
8.0 Critical Process Steps and 9
Process Parameters for
Validation with Justification
9.0 Process steps Sampling and 14
Analysis Plan with Acceptance
Criteria
10.0 Holding Studies 15
11.0 Revalidation 19
12.0 Deviations and Investigations 20
13.0 Validation Report 20
14.0 Reference Documents 20
15.0 List of Annexes / formats 20
Attached

PROTOCOL APPROVAL SHEET

Prepared by
Functional Name Designation Signature Date
Area
Quality
Assurance

Checked by
Functional Name Designation Signature Date
Area
Production
Quality
Assurance

Approved by
Functional Name Designation Signature Date
Area
R&D
Production
Quality Control
Quality
Assurance

Objective
To provide documented evidence with high degree of assurance that the manufacturing process is
capable of producing the finished product consistently of required quality, meeting its predetermined
specifications and quality attributes.
Scope
This process validation protocol is applicable to carry out process validation of Name of the Product
for first three consecutive commercial batches in view of the requirements of Name of market at
formulation Plant of Pharmaceutical Company.
Responsibility
Quality Assurance : Preparation, review and approval of process validation protocol.
Production : Production to approve the process validation protocol.
Quality Control : QC to approve the process validation protocol.
IPQA : Sampling of samples as per the sampling plans
Discussed in this process validation protocol.
Engineering : To provide support with respect to utilities and equipment
Validation Team Members
Validation team shall comprise of the representatives from following functions:
Production
Quality Control
In-process Quality Assurance
Quality Assurance
Engineering
The validation team shall be authorized by Head-QA or his/her designee as per the format attached
as Annexure
Abbreviations
Write the Abbreviations here.
Pre-requisites for Validation
Process Equipment
All equipment to be used for the manufacturing must be qualified as per IQ/OQ/PQ acceptance
criteria. The following equipments are to be used for manufacturing of Name of the Product.

Equipment ID Processing
S.No. Equipment Name Process Step
No. Area

Note: List of equipments used in the manufacturing process shall be prepared as per the
format attached as Annexure.
Equipment / Instruments for In-process checks
The following calibrated equipment / Instruments shall be used for in-process checks.
S. Equipment /Instrument Equipment ID.
No. Name No.

Documents
Following specifications and Standard Test Procedures shall be referred for carrying out testing of
validation samples.
*Spec. No. *STP No.
(Granules stage)
(Uncoated tablets)
*Testing of samples shall be done as per current version of Spec., STP and GTP.
Approved Raw Materials
Information related to raw materials shall be recorded in Annexure.
Manufacturing Procedure Under Validation
Refer BMR: Manufacturing procedure: Master Formula No.
Manufacturing procedure in brief comprise of following steps:
Refer annexure for process flow chart.
Critical Process Steps and Process Parameters for Validation with Justification
Process Process
Step Parameters Justification
Process Steps Sampling and Analysis Plan with Acceptance Criteria
Process Step Sampling and Analysis Plan
with Acceptance Criteria
Refer Annexure-
Holding Studies
Process Step Holding Studies Sampling and Analysis
Plan with Justification
Write the Write clearly Qnty of material to be kept
process stage under these studies, Frequency of sampling,
test parameter, packaging type, and area of
storage, test method and acceptance criteria
of test method.

Revalidation
If required, revalidation shall be considered and carried out when any of the following conditions
occur or prevail:
-Change in critical formulation component i.e. raw material
Change in manufacturer or vendor of Active Pharmaceutical Ingredient
Change in critical specifications of the product
Change in manufacturing process which may affect the quality of the products.
Change in the facility and /or plant (location or site)
Change in batch size, if more than ten times of the present batch size
Note: In case of the requirements for revalidation, because of above mentioned reasons, the
validation of the critical steps shall be undertaken through addendum protocol to this protocol or a
separate protocol.
Deviations and Investigations
Any deviation to this protocol and thereupon investigation shall be recorded as per SOP
and investigation on out-of-specification test results shall be recorded as per SOP .
Validation Report
Based on the outcome from this validation study, a report shall be prepared by Quality Assurance
persons. This validation report shall be reviewed and then approved by all functional heads of all the
concerned departments.
Reference Documents
In-process Specifications (write the doc name)
Eur.
GTP No.:
List of Annexures / Formats Attached (the following documents are written as annexure
format during protocol preparation )
Validation team members Annexure
Equipment list Annexure
Approved raw materials list Annexure
Process flow chart Annexure
Critical process variables Annexure
Sampling plan and analytical data compilation Annexure
Environmental monitoring record (holding studies) Annexure
Process validation report cover page Annexure
Process validation report approval sheet Annexure
Process validation report Annexure