Point No.       Section Title               Pages No. 
       NA Contents     01
       NA Protocol Approval Sheet    02
       1.0 Objective     03
       2.0 Scope     03
      3.0 Responsibility     03
       4.0 Validation Team Members     03
      5.0 Abbreviations    04
      6.0 Pre-requisite for Validation    04
      7.0 Manufacturing Procedure Under Validation    06
      8.0 Critical Process Steps and Process Parameters for Validation with Justification    09
      9.0 Process steps – Sampling and Analysis Plan with Acceptance Criteria    14
      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 Attached   20



Prepared by

Functional Area Name Designation Signature Date
Quality Assurance


Checked by

Functional Area Name Designation Signature Date 
Quality Assurance


Approved by

Functional Area Name Designation Signature Date 
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.

S.No. Equipment Name Process Step Equipment ID No. Processing 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. No. Equipment /Instrument Name Equipment ID. 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 Step        Process 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 process stage Write clearly Qnty of material to be kept 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


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