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To provide general guideline for conducting process validation of the products.
- 0 SCOPE:
This procedure is applicable to Manufacturing section at company location.
- 0 RESPONSIBILITY:
- 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.
- 0 PROCEDURE:
- 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:
- 1. Definitions :
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.
- 0 ANNEXURE:
- 0 REFERENCES:
- 0 ABBREVIATION:
Abbreviation used Full form of abbreviation used
QA Quality Assurance
QC Quality Control
QAD Quality Assurance Department
- 0 DISTIBUTED TO:
Manufacturing & Capsule
Quality Control & Microbiology
- 0 REVISION HISTORY:
|Revision No.||Change Control No.||Reason for the Modifications|
Posted by Karamshi Chaudhar