Process Validation of Product


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1.0              OBJECTIVE:

To provide general guideline for conducting process validation of the products.

  • 0 SCOPE:

This procedure is applicable to Manufacturing section at company location.

    • 1. QA Manager/ QA Executive shall be responsible to prepare a protocol for process validation and sampling plan.
    • 2. QA Officer shall be responsible of sampling and fill on line process validation report as per protocol.
    • 3. QC Officer shall be responsible for analysis of the process validation samples.
    • 4. Production Officer shall be responsible to operate the machine / procedure as defined in the process validation protocol.
    • 5. QC Manager, Production Manager and QA Manager shall be accountable for review and approval of process validation protocol and report.
    • 1. Definitions :
      • 1.1. It is a high degree of assurance in the performance of the manufacturing process such that it will consistently produce finished products meeting those attributes relating to strength, quality, purity, and potency.
      • 1.2. Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
      • 1.3. It is a study to ensure that the manufacturing process is capable to give consistency results to meet the quality (safety, efficacy & purity) of the product during routine manufacturing processes.
    • 2. Re-validation Criteria :
      • 2.1. If any change in the process formula.
      • 2.2. Change in approved vendor.
      • 2.3. Change in manufacturing location.
      • 2.4. Change in equipment / facility.
      • 2.5. External Agency / Regulatory requirement.
      • 2.6. Any quality impact on the product monitor during annual product review.
    • 3. When any new product / formulation to be manufactured, it must be prior to validate the process.
    • 4. Each critical process steps, hold time study must be identified and validate.
    • 5. In the protocol product details, formula details, sampling plant, critical process steps, deviations must be reported.
    • 6. Process validation protocol shall be contain at least following contents :
      • 6.1. Protocol Approval:

In this content give details of authorized personnel who will prepared, checked, review and approved the protocol.

  • 6.2. Table of Content :

Give table contents with title and page number.

  • 6.3. Objective :

Give brief objective of the validation.

  • 6.4. Scope :

Mention the scope for which product and location the process validation should be conducted.

  • 6.5. Responsibility :

Mention the responsibilities of validation team.

  • 6.6. Process Validation Requirement :

Described general precautions before starting the validation activities.

  • 6.7. Product Description and Batch Details :

Give the details of the product which shall be going for validation.

  • 6.8. Bill of Raw Material :

Describe the raw materials (active and / or inactive) containing in the product for each stage.

  • 6.9. Bill of  Primary Packing Material :

Describe the packing materials which are to be used for packing of product.

  • 6.10. List of Critical Equipment/Accessories :

List down the equipments/accessories which are to be used to manufactured the product.

  • 6.11. Summary of Critical Process Parameters to be Validated :

List down critical process parameters / stage with monitoring of quality attributes.

  • 6.12. Manufacturing Process Steps and Critical Parameters :

Draw the process steps in brief.

  • 6.13. Packing Process Parameters :

Collect the samples from frequently during packing process and check quality attributes of the product.

  • 6.14. Summary Observations and Results :

Give the summary and conclusion of the various process steps.

  • 6.15. Certification Report :

Give final conclusion on the basis of report review.

  • 6.16. Report Approval :

In this content give details of authorized personnel who will conducting, checked, review and approval of the Report.

  • 6.17. List of Annexes :

List down the annexes if any and attach with report.

  • 6.18. Revision History :

Give history of the revision with justification.






Abbreviation used       Full form of abbreviation used

QA                              Quality Assurance

QC                              Quality Control

QAD                           Quality Assurance Department


Quality Assurance

Manufacturing & Capsule

Quality Control & Microbiology

Revision No.Change Control No.Reason for the Modifications

Posted by Karamshi Chaudhar


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