SOP for Process Validation

OBJECTIVE

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

SCOPE

This procedure applies to the Manufacturing section at PharmaInfo Ltd.

RESPONSIBILITY

• QA Manager/ QA Executive shall be responsible for preparing a protocol for process validation and sampling plan.
• QA Officer shall be responsible for sampling and filling online process validation reports as per protocol.
• QC Officer shall be responsible for the analysis of the process validation samples.
• Production Officer shall be responsible for operating the machine/procedure as defined in the process validation protocol.
• QC Manager, Production Manager, and QA Manager shall be accountable for the review and approval of process validation protocol and report.

PROCEDURE

• Definition: 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.
• 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.

• It is a study to ensure that the manufacturing process is capable of giving consistent results to meet the quality (safety, efficacy & purity) of the product during routine manufacturing processes.

ALSO READ: SOP for Concurrent Process Validation

• Re-validation Criteria

1. If any change in the process formula.
2. Change in an approved vendor.
3. Change in manufacturing location.
4. Change in equipment/facility.
5. External Agency / Regulatory requirement.
6. Any quality impact on the product monitor during the annual product review.
7. When any new product/formulation is to be manufactured, it must be prior to validating the process.
8. Each critical process step, and hold time study must be identified and validated.

• In the protocol product details, formula details, sampling plant, critical process steps, and deviations must be reported.
• Process validation protocol shall contain at least the following contents :
• Protocol Approval: In this content give details of authorized personnel who will prepared, checked, review and approved the protocol.
• Table of Content: Give table contents with title and page number.
• Objective: Give brief objective of the validation.
• Scope: Mention the scope for which product and location the process validation should be conducted.
• Responsibility: Mention the responsibilities of the validation team.
• Process Validation Requirement: Describe general precautions before starting the validation activities.

• Product Description and Batch Details: Give the details of the product that shall be going for validation.
• Bill of Raw Material: Describe the raw materials (active and/or inactive) contained in the product for each stage.
• Bill of Primary Packing Material: Describe the packing materials which are to be used for the packing of the product.
• List of Critical Equipment/Accessories: List down the equipment/accessories that are to be used to manufacture the product.
• Summary of Critical Process Parameters to be Validated :
• List down critical process parameters/stages with monitoring of quality attributes.
• Manufacturing Process Steps and Critical Parameters: Draw the process steps in brief.
• Packing Process Parameters: Collect the samples frequently during the packing process and check the quality attributes of the product.
• Summary Observations and Results: Give the summary and conclusion of the various process steps.
• Certification Report: Give final conclusion on the basis of report review.

• Report Approval: In this content give details of authorized personnel who will be conducting, checked, review and approval of the Report.
• List of Annexes : List down the annexes if any and attach with report.
• Revision History: Give a history of the revision with justification.

ANNEXURE

Nil

REFERENCES

Nil

ABBREVIATION

QA: Quality Assurance

QC: Quality Control

QAD: Quality Assurance Department

REVISION HISTORY

Nil

ALSO READ: SOP for Transport Validation