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
|
|
|
|
|
