Template for Process validation protocol

Template for Process validation protocol

To provide documented evidence with a high degree of assurance that the manufacturing process is capable of producing the finished product consistently of the required quality, meeting its predetermined specifications and quality attributes.

Scope: This process validation protocol is applicable to carry out process validation of the Name of the Product for the first three consecutive commercial batches given the requirements of the Name of the market


Quality Assurance: Preparation, review, and approval of process validation protocol.

R&D: R&D to approve the process validation protocol

Production: Production to approve the process validation protocol.

Quality Control: QC to approve the process validation protocol.

PDL: To review the process validation protocol.

IPQA: Sampling of samples as per the sampling plans discussed in this process validation protocol.

Engineering: To provide support concerning utilities and equipment

Validation Team Members

The validation team shall comprise the representatives from following functions:

The validation team shall be authorized by the Head-QA or his/her designee as per the format attached as Annexure


Quality Assurance

In-process Quality Assurance

Quality Control

Process Development


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 equipment is to be used for manufacturing of Name of the Product.

Note: A list of equipment 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.


The following specifications and Standard Test Procedures shall be referred to for carrying out the testing of validation samples.

Spec. No./ *STP No. At the Granules stage & Uncoated tablets

GTP No.: Testing of samples shall be done as per the 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 to MFR: Manufacturing procedure: Master Formula  Manufacturing procedure in brief comprises of the following steps:

Refer annexure for the process flow chart.

Critical Process Steps and Process Parameters for Validation with JustificationProcess 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 Qnty of material to be kept under these studies, Frequency of sampling, test parameter, packaging type, area of storage, test method, and acceptance criteria of test method.


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
  • Changes in the manufacturing process 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 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 an 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 of this validation study, a report shall be prepared by Quality Assurance and Quality Control 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)
  • Exhibit Batch Summary Report
  • Eur.
  • GTP No.:

List of Annexures / Formats Attached (the following documents are written in 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 for dry mixing  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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