Qualification of manufacturating equipments

1. Under the Guidence
of
J.Subbarao M.Pharm.
Asso.Professor
BY
K.SIVA GANESH
I/II M.PHARM
PHARMACEUTICAL ANALYSIS
Y17MPH0557

2.  INTRODUCTION
 QUALIFICATION PHASES
1. DESIGN QUALIFICATION
2. INSTALLATION QUALIFICATION
3. OPERATIONAL QUALIFICATION
4. PERFORMANCE QUALIFICATION
 RE-QUALIFICATION
 REFERENCES

3. WHAT IS VALIDATION ??
 Establishing documented evidences
 Provides high degree of assurence
 A specific process will consistently produce a
product meeting its predetermined specifications and
quality attributes.

4. Steps involved in qualification of manufacturing
equipments
● Design Qualification (DQ)
● Installation Qualification (IQ)
● Operational Qualification (OQ)
● Performance Qualification (PQ)

5.  Manufaccturing equipments are custom
made.
 Features of equipment needs to be
mentioned to the fabricator.
 Basic features like dimensions, materials used
for contact & non contact parts, details of
motors,etc..,
 Easy clean ability and maintainence aspects.

6. When to prepare DQ ??
its prepared before purchasing the
equipment and this should on the basis of purchasing
equipment.
Who prepares and approves the DQ ??
jointly prepared by user and represntatives of
enginering deportment and approved by the enginering
and quality assurance deportment.

7. The basic principles are :
 Equipment be correctly installed in accordance with
installation plan.
 Requirements for calibration, maintenance and
cleaning be covered in approved SOP's.
 Equipment is tested to assure is it operating correctly,
under normal and worest case conditions.

8. IQ for any equipment requres check of all
installed equipment againest the equipment supplier’s
specifications and users purchase specifications.
These checks and tests should be repeated for
number of times to assure meaningful results.

9. An ideal IQ protocol shall document the following :
 Objective
 Equipment description & identifiction
 Equipment masterfile
 Major comonents
 Material of construction
 Safety features & alarams

10.  Utilities
 Identification of standard operating procedures
 Installation verification
 Acceptance criteria

11.  Equipment is tested and verified that it operates
according to its specifications.
 The place in which the equipment is set up is tested
according to metrological aspects.
 OQ shold identify the studies to be undertaken on the
critical variables.
 It includes set of conditions encompassing upper & lower
processing limits and circumstances.

12.  OQ is to be carried out in accordence to an appproved
protocol.
 OQ involves testing and ensuring that IQ is
appropriate.
 OQ is to be performed without any load.
 The satisfactory completion of OQ gives an
assurance that the mechine is satisfactory for use.

13. Contents of Operational Qualification for an equipment :
 Objective
 Instrumentation calibration
 Control panel testing
 Safety features testing
 Verification of standard operating procedure
 Operational testing
 Acceptance criteria

14.  PQ is documented proof that the equipment functions in
your facilities exactly as intended.
 This is ensured by verifying the suitability of the
equipment under actual operating conditions.
 PQ reviews critical parameters of equipment using
suitable test methods.
 These procedures are documented in the form of test
specifications.

15.  Methodology for PQ is similar to as proposed
for OQ.
 The difference in it is OQ is performed
without load and the PQ is performed with
load.

16.  Modifications to, or relocation of, equipment should only
follow satisfactory review and athorisation of the
documented change praposal through change control
procedure.
 Review procedure includes consideration of re-
qualification of equipments.
 Minor changes should be handled through the
documentation system of the preventative maintainence
system.

17.  Basics of Validation – Pharmaceutical Perspectives
By K.Kathiresan And K.Kiran.
 Analytical Method Development And Validation By
Michael E. Swartz And Ira S.Krull.