1.0.
OBJECTIVE:
1.1.
To provide
a guideline procedure for framing the validation plan for the equipments /
instruments / utilities / systems / premises / process used for manufacturing
of the drug products.
2.0.
SCOPE:
2.1.
This Procedure is
applicable to the various validations to be carried out for pharmaceutical
products that require high degree of assurance of quality and purity standards
which are manufactured at Company.
3.0.
RESPONSIBILITY:
3.1.
The Officer / Executive / General Manager / In-charge of QA
department shall be responsible for preparation of validation master plan.
4.0.
PROCEDURE:
4.1.
Preparation of Validation Master Plan
Note:
VMP is pre decided document that describe comprehensive plan for
validation of different pharmaceuticals facility.
4.1.1.
For drug
products, validation studies described to confirm that the product is
manufactured with predetermined quality attributes by documenting that the
facility equipment, manufacturing procedure & quality controls achieve
expected results.
4.1.2.
VMP shall be developed
by Manager -Quality Assurance in association with General Manager and other
technical experts.
4.1.3.
VMP shall be approved by Manager– QA.
4.1.4.
Approved copy of VMP shall
be kept by QA department.
4.1.5.
VMP contain all
validation frequency for equipment / instrument / utilities / process /
facility validation.
4.1.6.
The VMP
shall consist the brief information of the site where in the location, address,
built up area, available land; type of building shall be indicated.
4.1.7.
VMP helps
to management, validation team members, GMP inspectors & project leaders.
4.1.8.
It shall
include the planned servicing & maintenance of all the critical instruments
/ equipment to enable them usable / workable efficiently at the optimum level throughout
the year.
4.1.9.
The VMP
shall include IQ, OQ , PQ
4.1.10.
Revalidation
/ Prequalification of major critical equipments shall be performed &
planning schedule shall be framed as per the requirement.
4.1.11.
In case of any changes are required in the approved plan following
procedure shall be followed.
4.1.11.1.
Change control proposal shall be prepared with proposed change
& proper justification.
4.1.11.2.
Change control proposal filled by respective department is
approved by QA- Manager.
4.1.11.3.
After approval from QA-Manager respective changes shall be
accepted & change shall be made in approved validation master plan.
4.1.12.
Validation Master Plan shall consist following components as
minimum,
4.1.12.1.
Brief description of plant, process &
product.
4.1.12.2.
Summary of facilities, systems, equipments
& process to be validated.
4.1.12.3.
Equipments
required in manufacturing to process products
4.1.12.4.
QC analytical
instruments.
4.1.12.5.
Description of manufacturing
process (stepwise) in detail and steps to be validated.
4.1.12.6.
Prospective,
concurrent, retrospective validation.
4.1.12.7.
Re-validation
activities, actual status & future planning.
4.1.12.8.
Change control.
4.1.12.9.
Validation policy.
4.1.12.10. Document formats for protocol & reports.
4.1.12.11. Qualification of equipments & machineries.
4.1.12.12. Training.
4.1.12.13. Validation plan & schedule.
4.1.12.14. Validations: Analytical Method Validation
& Cleaning Validation.
4.1.12.15. Cleaning
procedures and analytical methods for evaluating the cleaning validations.
4.1.12.16. Calibration
programmed summary.
4.1.12.17. Validation
team with specific responsibilities.
4.1.12.18. Any
other additional validation requirements that may be required to augment
validation plan.
4.1.12.19. A
description of the organization and responsibilities for validation.
4.1.12.20. The
documentation management and control system to be used.
4.1.12.21. A
description of the validation change management process.
4.1.12.22. An
indicative relative timescale plan.
4.2.
VMP numbering system
4.2.1.
VMP numbering system shall be given as following procedure.
4.2.1.1.
AAA/BBB/CC/YY
4.2.1.1.1.
Here AAA is indicating Validation master plan as a VMP.
4.2.1.1.2.
Here BBB is indicating company name. Here CC is indicating year for
preparation of VMP in two numerical digits. (e.g. 09, 10, 11…).
4.2.1.1.3.
Here YY is indicating version no. in two numerical digits. (e.g.
00, 01, 02…).
4.2.2.
If VMP revised than version no. shall be changed.
4.3.
Definition
4.3.1.
The VMP is a high-level
document that establishes an umbrella validation plan for the entire project
and summarizes the manufacturer’s overall philosophy and approach, to be used
for establishing performance adequacy. It provides information on the
manufacturer’s validation work programmed and defines details of and timescales
for the validation work to be performed, including a statement of the
responsibilities of those implementing the plan.
4.3.2.
A documented plan (VMP)
that describes the policy, philosophy, strategy, and methodology for validating
a site, process, or product. The plan can be used as an executive summary
within a company or to introduce regulatory personnel to a validation project.
The plan should identify responsibilities, as well as equipment and processes
requiring qualification or validation. It also may include schedules for an
overall process.
4.3.3.
An approval written plan of objectives & actions stating how
& when a company will achieve compliance with the GMP requirements
regarding validation.
5.0.
ANNEXURE:
Nil
6.0.
REFERENCES:
Nil
7.0.
ABBREVIATION:
Abbreviation used Full form of abbreviation used
SOP Standard
Operating Procedure
IQ Installation
Qualification
OQ Operational
Qualification
PQ Performance
Qualification
RQ Re-Qualification
RV Re-Validation
VMP Validation
Master Plan
GMP Good
Manufacturing Practices
QA Quality
Assurance
QC Quality
Control
8.0.
DISTRIBUTED TO:
Quality Assurance
Manufacturing
Warehouse
Quality Control
Engineering
9.0.
REVISION HISTORY:
|
Revision No.
|
Change
Control Number
|
Reason
for the Modifications
|
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