Point No.      Section Title              Pages No. 
       NAContents    01
       NAProtocol Approval Sheet   02
       1.0Objective    03
       2.0Scope    03
      3.0Responsibility    03
       4.0Validation Team Members    03
      5.0Abbreviations   04
      6.0Pre-requisite for Validation   04
      7.0Manufacturing Procedure Under Validation   06
      8.0Critical Process Steps and Process Parameters for Validation with Justification   09
      9.0Process steps – Sampling and Analysis Plan with Acceptance Criteria   14
      10.0Holding Studies  15
      11.0Revalidation  19
      12.0Deviations and Investigations  20
      13.0Validation Report  20
      14.0Reference Documents  20
      15.0List of Annexes / formats Attached  20



Prepared by

Functional AreaNameDesignationSignatureDate
Quality Assurance


Checked by

Functional AreaNameDesignationSignatureDate 
Quality Assurance


Approved by

Functional AreaNameDesignationSignatureDate 
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 NameProcess StepEquipment 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 NameEquipment 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 stageWrite 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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About Pharmaceutical Guidanace

Alice is the Author and founder of pharmaceutical guidance, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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