In this slide contains introduction, qualification, preventive maintenance, requalification method. Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur

1. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
A Seminar as a part of curricular requirement
for I year M. Pharm II semester
Presented by
M.MALARVANNAN. (20L81S0704).
M.PHARM
Department of Pharmaceutical Analysis
REQUALIFICATION

2. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
S.NO CONTENT
1 Introduction
2 Qualification
3 “V” Model for Qualification and Validation
4 Qualification phrases 4Q Model
5 Requalification method
6 Requalification procedure
7 Preventive maintenance
8 Role of instrument requalification
9 Requalification required for
10 Reason for conducting instrument Requalification
11 Reference
Content Table

3. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3
Requalification:-
• The action of repeating the qualification or reconfirming that
process, product or equipment is suitable for a particular position
or task.
• Requalification of systems and equipment should be done in
accordance with a defined schedule.
• The frequency of requalification may be determined on the basis of
factors such as the analysis of results relating to calibration,
verification and maintenance.
Introduction

4. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4
• Qualification: ensuring in the case of new equipment/facilities or
equipment entering into service that they serve their intended
purpose.
• Requalification: ensuring that the equipment is still in the qualified
state after a change AND periodical assessment of equipment
within defined time intervals.
GMP definitions

5. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5
Qualification
Qualifying the instrument, Utility, System
By means of Test
Working conditions Ok/Not Ok
Creating a document evidence
It shows the stability of instrument for intended
purpose

6. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 6
“V” Model for Qualification and
Validation

7. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7
Qualification phrases 4Q Model

8. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8
• DQ should provide documented evidence that the design
specification were met and are in accordance with URS.
• User requirement specifications:
• Product requirements
• Process & operation requirements
• Operation ranges
• GMP, operation & safety requirements
• FAT and SAT:
• It should be performed to verify the suitability of the system at site, prior
to the subsequent stages of qualification.
Design Qualification

9. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9
DQ- template

10. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10
• Demonstrate that equipment's has been installed as per design and
installation requirements.
• Installation checklist:
• Civil requirements
• Electrical
• Production
• Measuring instruments
• Utilities and piping
• Safety issues
• Operation manual & SOP’s
• Critical stages
• Spare parts list etc..
Installation qualification

11. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11
• Tests that meet the functionality requirement of process, system
and equipment.
• To include a condition or a set of condition encompassing upper
and lower operating limits, and “worst case conditions”.
• Finalisation of calibration, operation and cleansing procedures.
• Operator training and preventive maintenance requirements
• Conclusion to approve/ release the facilities, systems and
equipment's.
Operational Qualification

12. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12
PQ should include, but not be limited to the following:
Test, using production materials, qualified substitutes or simulated products.
Test to include conditions or set of conditions encompassing upper and lower
limits.
Although PQ is described as a separate activity. It may in some cases be
appropriate to perform conjunction with OQ.
Performance Qualification

13. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 13
TYPE REQIRMENT EXAMPLE
GROUP-A Only IQ, Formal OQ Hot plate, stirrers, Oven,
Centrifuge,..
GROUP-B IQ, OQ mandatory PH meters, weighing
balance, Polarimeter,
Conductivity meter...
GROUP-C IQ, OQ, PQ must All instrument with
system (CPU) /21 CFR
Part-II, HPLC, UV, GC, LC-
MS, FT-IR....
Types of instrument as per GMP/FDA

14. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 14
Qualification of Analytical Instruments
SST-----Check----Meet the limit---------- Go For QC sample
SST-----Check----Not meet the limit-----Go for instrument Qualification

15. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 15
Requalification Method

16. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16
Requalification includes the following terms:
*Maintaining Status for Calibration
*Preventive maintenance
*Change management
Requalification Procedure

17. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 17
• The quality of product directly associated with accuracy of
instrument Producing them.
• If the instrument not calibrated or If damaged They will surely
affect the products.
• It is important to remember instrument and equipment will not
always calibrated.
• At some point the level of calibration Go down and it will affect
the final measurement and quality of final product.
• It must be kept in excellent condition at all time.
Maintaining Status for Calibration

18. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18
1. Manufacturers recommendations
2. Annually Or biannually
3. After a damaging incident
4. As demanded by project
5. Before or after major product
6. Semi-annually, quarterly, Or monthly
How it is Done frequently (calibration or
Recalibration)

19. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 19
• It is regularly performed on a piece of equipment Lessen The
likelihood Of it failing.
• It is performed while the Equipment is still working So that it does
not Breakdown unexpectedly.
Preventive maintenance

20. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 20
• Original manufacturers Recommendation
• Meeting the regulatory requirements
• Maintaining the performance specifications of instrument
• Increasing the life of equipment
• Maximizing uptime And minimizing corrective Maintenance
• Assuring the efficiency of instrument
The topical rationale for performing
Preventive maintenance

21. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 21
• Change management is a system approach to Dealing with the
Transition or transformation of an organization goals or process.
• The purpose of this To implement strategies of effective change,
controlling change.
• Change and deviation management is the central part of QMS.
• According to FDA and ICH a formal CMS should be established to
evaluate all changes.
Change management

22. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 22
• Decrease Bias
• Decrease OOS
• Decrease OOC
• Reassure the equipment function, working conditions
• Reassure the implement process/ procedure is correct
• Provide high degree of assurance
Role Of Instrument
Requalification

23. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 23
• Significant change in batch size
• Change in operating parameters
• Component specification have changed
• Accessories or components added To the previously qualified
equipment's.
• Process change that potentially impact on Product effectiveness
or quality.
Requalification required for?

24. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 24
• Identify and correct the deficiencies Observed during Qualification
• Criteria For Qualification test need to be added
• Qualification changes to equipment or Process involving equipment
• CAPA
• Failure
• Inspection /Audit/PQR/finding/Recommendations
• Results of PM, calibration Programs
• Upgrade of equipment
Reason For Conducting
Requalification

25. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 25
1. ECA Academy Your GMP/GDP Information source “Qualification, Requalification -
frequent Obscurities”, 2013.
2. Ludwig Huber. “ US & EU GMP Guidelines on analytical instrument Qualification and
related warning letters”, Agilent tech slides, 2014. www.Labcompilence.com/Agilent
3. EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and
Veterinary Use, volume-4, Annex 15: Qualification and Validation, 2015
4. Manoj V. Kumbhar. “ Preventive maintenance and calibration”, 2016.
www.slideshare.com
5. Melissa Stappen, ValSource “Using Preliminary Hazard Analysis To Determine
Equipment And Instrument Requalification Frequency”, 2018.
6. R.D. McDowall, Paul Smith. “Data Integrity and USP : Part 3: Monitoring and
Requalification”, LCGC Europe, LCGC Europe-01-01-2019, Volume 32, Issue 1 Pages:
28–32
7. Pharma beej, “Equipment Qualification principles and practice in pharma”, 2021.
Reference: