What, when, Why and How Pharmaceuticals qualification..?

1. An Approach on Pharmaceuticals
Qualification

2. Documented verification that
the environment and
equipment are properly
installed & function as
designed.
What Is
Qualification

3. In order to maintain quality, standards, safety,
lower costs and to really operate your
equipment the way it should be operated, it is
not only a plus, but absolutely necessary to
obtain calibration and validation services for
your equipment.
If you don’t have adequate information and
knowledge about your products, how can you
possibly know if they are functioning the way
they should be?
Unless you have qualified professionals testing
your equipment, you’ll be in the dark.
Information is power.
Have your equipment qualified and validated,
and you and your products will be at the top of
your game. Make sure you are truly meeting
your standards.
Why
Qualification

4. Any time, if introduce with
followings:-
• New equipment/utility
• Major break down in equipment/utility
• Modification in facility/utility
• Scheduled qualification
WHEN
Qualification Is
Required

5. Users Requirement
Specification (URS)
Design Qualification (DQ)
Factory Acceptance Tests
(FAT)
Site acceptance test
(SAT)
Installation Qualification
(IQ)
Operational Qualifications
(OQ)
Performance Qualification
(PQ)
Segments of
Qualification

6. Definition:
A requirement specification that describes
what the equipment or system is suppose
to do, thus containing a list of criteria or
conditions that have to be met.
Purpose:
The objective of URS is to collect the
requirement of user’s w.r.t. functionality,
safety and GMP aspects.
Users
Requirement
Specification
(URS)

7. Document to define the users need for the equipment,
GMP aspects,
MOC,
Cleaning accessibility,
capacity,
speed,
Level of automation (PLC),
Power failure,
process & safety requirements etc.
URS
Minimum
Acceptance
Criteria

8. Definition:
Systematic verification that the requirements
defined in the specification phase is
completely covered by the succeeding
specification or implementation phase.
Purpose:
The objective of is to provide all
specifications of the equipment / instrument
by the manufacturer.
Design
Qualification

9. DQ should meet the all
requirements of users
specification and shall be
verified by the user. The DQ
shall include the following or
as applicable to the
equipment:
•Dimensions,
•Technical Specification of
equipment as well as bought out
items,
•Safety,
•P&ID,
•Electrical schematics,
•Process and utility,
•Piping routes and dimensions,
•Utility,
•Material of Construction.
DQ
Minimum
Acceptance
Criteria

10. Definition:
Establishing documented evidence that the vendor
fabrication process or materials and completed equipment
meet vendor and customer specifications.
Purpose:
The objective of Factory Acceptance Test is to verify that
the main items or system meets design specification and
conforms to agreed performance intent. The test will be
performed and reported by the supplier. All tests
performed during FAT must be performed in accordance
with reviewed and approved protocols and procedures.
Factory
Acceptance
Test

11. The items of equipment and systems shall
comply with:
• • Vendor requirements and specifications
• • Purchase specifications
• • Design drawings
• • Engineering diagrams
• • Safety rules
It shall be checked that following
documentation is provided:
• • User manual
• • Maintenance manual
• • Piping and installation design
• • Electrical schematics
• • Process and utility diagram
• • Weld documents
• • Spare part list
FAT
Minimum
Acceptance
Criteria

12. Establishing documented
evidence that the during
receipt of the item at site,
confirms with the standard laid
in the protocol
Site
Acceptance
Test (SAT)

13. Definition:
Establishing documented evidence that the facility,
system, equipment, operations, are installed
according to design requirements and complies with
the manufacturer’s specification.
Purpose:
The purpose of Installation Qualification of Equipment
is to verify that all GMP-related equipment included in
the delivery is received and installed according to
design documents and purchase specifications. An
examination should be performed prior to shipment
(FAT) as well as at the final site. Those parts of the
systems which are disassembled prior to shipping
should be noted and be verified again after re-
assembly at the final site.
Installation
Qualification

14. Each examined component (equipment,
instruments and materials) meets:
• Brand, type or model,
• The items of the equipment and systems shall
comply with the IQ Protocol,
• Delivered undamaged and as specified,
• Installed correctly according to drawings and
specifications and verified,
• Calibrated and supported with documentation of the
calibration.
The following documents shall be a
requirement of the IQ:
• User manual
• Maintenance manual
• Lubricant list
• P&ID
• Electrical schematics
• Process and utility diagram
• Piping routes and dimensions
• Installation order of components
IQ
Minimum
Acceptance
Criteria

15. Utility connections
Electrical
connections
Piping slopes
Piping insulation
Piping and
component labeling
Material certificate
Weld documents Spare part list
Installation layout
drawings
P& ID's (electrical,
water, air, pneumatic)
Technical
documentation for
the components
needed for operation
Maintenance
• Documentation to
support specified quality
of parts (e.g., material of
construction)
IQ
Minimum
Acceptance
Criteria

16. Definition:
Documented evidence that the facility, system,
equipment, operations, functions statically and
dynamically according to manufacturer’s
specification and design specification.
Purpose:
The purpose of Operational Qualification is to
verify that a system or subsystem performs as
intended throughout all anticipated operating
ranges.
Operational
Qualification

17. Each examined utility,
equipment or system
shall:
• Operate as described in
Operations Manual
• Operate as described in
Standard Operating Procedures
• Operate throughout all intended
and worst case operating
ranges
• Operate reliably
• Meet all parameters (such as,
flow rates, temperatures,
speeds, control sequences)
OQ
Minimum
Acceptance
Criteria

18. Definition:
Establishing documented evidence that the
integrated systems and/or processes are
capable of consistently performing to the
stated design requirements.
Performance Qualification may include
activities:
• Utility qualification (air / water / steam)
• HVAC qualification
• Equipment qualification (sterilizer / filling line / washing
machine / packaging machine)
• Environmental qualification
• Performance Qualification (PQ) precedes process
validation.
Performance
Qualification

19. Each examined
equipment, system
or process shall:
• Perform reproducibly
according integrated
systems and its intended
use.
• Meet all ranges,
microbiological, chemical,
or physical limits.
PQ
Minimum
Acceptance
Criteria

20. NAME:
DEWAN MD.
SUMSUZZMAN
Organization:
Mundipharma
(Bangladesh)
Pvt. Ltd.
Designation:
Officer, Quality
Assurance
Qualification:
M. Pharm
Thanking You