Process Validation of Product

1.0              OBJECTIVE:

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

2.0              SCOPE:

This procedure is applicable to Manufacturing section at company location.

3.0              RESPONSIBILITY:

3.1.            QA Manager/ QA Executive shall be responsible to prepare a protocol for process validation and sampling plan.

3.2.            QA Officer shall be responsible of sampling and fill on line process validation report as per protocol.

3.3.            QC Officer shall be responsible for analysis of the process validation samples.

3.4.            Production Officer shall be responsible to operate the machine / procedure as defined in the process validation protocol.

3.5.            QC Manager, Production Manager and QA Manager shall be accountable for review and approval of process validation protocol and report.

4.0              PROCEDURE:

4.1.            Definitions :

4.1.1.      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.

4.1.2.      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.

4.1.3.      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.

4.2.            Re-validation Criteria :

4.2.1.      If any change in the process formula.

4.2.2.      Change in approved vendor.

4.2.3.      Change in manufacturing location.

4.2.4.      Change in equipment / facility.

4.2.5.      External Agency / Regulatory requirement.

4.2.6.      Any quality impact on the product monitor during annual product review.

4.3.            When any new product / formulation to be manufactured, it must be prior to validate the process.

4.4.            Each critical process steps, hold time study must be identified and validate.

4.5.            In the protocol product details, formula details, sampling plant, critical process steps, deviations must be reported.

4.6.            Process validation protocol shall be contain at least following contents :

4.6.1.      Protocol Approval:

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

4.6.2.      Table of Content :

Give table contents with title and page number.

4.6.3.      Objective :

Give brief objective of the validation.

4.6.4.      Scope :

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

4.6.5.      Responsibility :

Mention the responsibilities of validation team.

4.6.6.      Process Validation Requirement :

Described general precautions before starting the validation activities.

4.6.7.      Product Description and Batch Details :

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

4.6.8.      Bill of Raw Material :

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

4.6.9.      Bill of  Primary Packing Material :

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

4.6.10.  List of Critical Equipment/Accessories :

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

4.6.11.  Summary of Critical Process Parameters to be Validated :

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

4.6.12.  Manufacturing Process Steps and Critical Parameters :

Draw the process steps in brief.

4.6.13.  Packing Process Parameters :

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

4.6.14.  Summary Observations and Results :

Give the summary and conclusion of the various process steps.

4.6.15.  Certification Report :

Give final conclusion on the basis of report review.

4.6.16.  Report Approval :

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

4.6.17.  List of Annexes :

List down the annexes if any and attach with report.

4.6.18.  Revision History :

Give history of the revision with justification.

5.0              ANNEXURE:

NIL

6.0              REFERENCES:

NIL

7.0              ABBREVIATION:

Abbreviation used       Full form of abbreviation used

QA                              Quality Assurance

QC                              Quality Control

QAD                           Quality Assurance Department

8.0              DISTIBUTED TO:

Quality Assurance

Manufacturing & Capsule

Quality Control & Microbiology

9.0              REVISION HISTORY:

Revision No.	Change Control No.	Reason for the Modifications