In this slide contains definition, validation plan, types of Qualification of Dry Powder Mixture. Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).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
Presented by
D. Ravi Shankar
(20L81S0403)
Department of Pharmaceutical Quality Assurance
QUALIFICATION OF DRY
POWDER MIXER

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 Definitions
2 Why to Validate
3 Types of Validation
4 Validation Plan
5 Qualification of Dry Powder Mixer
6 Types of Powder Blenders
7 Variable and Monitoring
8 Revalidation criteria
9 Bibliography
Contents

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
• Validation :
This term comes from the word “valid or validity” which means “legally defined”.
The validation process is the documented evidence which provides a high degree of
assurance to a desired result with predetermined compliance.
• 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.
Definitions

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
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

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
Equipment validation is vital for
 Safety
 Fewer interruptions of work
 Lower repair costs
 Reduction of variations in results
 Greater confidence in reliability of results
Why to Validate

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
Validation Types

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/
Validation Plan

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
Why it is essential :
Mixing of API & excipients is the critical step in the solid dosage form preparation
that affects the content uniformity at great extent.
Types of Powder Blenders :
Qualification of Dry Power Mixer

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
Cont…
Ribbon blender
Octagonal blender
Conical screw mixer
Double cone blender
Double cone blender Drum mixer

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
Variable and Monitoring
variables
RPM Mixing
time
Mixing
load
Monitoring –
Blend Uniformity

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
Equipment name, made by and model number shall be noted down.
Location for the installation of equipment shall be checked
Utilities required shall be listed down
Any deviation observed while following above procedure shall be informed for
corrective action
Design Qualification (DQ)

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
After checking all the specifications as mentioned in the selection criteria, service
engineer shall commission the equipment.
Authorized validation team shall carry out installation checks as per the
specification criteria
Installation Qualification (IQ)

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
After completion of IQ, initiate the actual operation, to ensure
that machine is operating within the specification.
Check the operation qualification parameters against their specifications
Document the deviation details
The quality head and the department head shall decide whether the deviation is
acceptable or not
Operational Qualification(OQ)

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
Load the materials to be mixed in the mixer
Start the mixer and rotate it for the time as mentioned in the BMR
After completion of mixing switch OFF the mixer and separate out the drum
Collect he sample as per sampling procedure
Send the samples to quality control department for content uniformity, bulk density
& sieve analysis
Performance Qualification (PQ)

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
Sampling points:
*Top
*Middle
*Bottom - of the equipment
Sl. No Quality contents Acceptance limit
1 Content Uniformity Depend on MFR
2 Sieve Analysis Depend on MFR
3 Density Depend on MFR

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
Revalidation Criteria :
• Revalidation is the process that ensures any changes made intentionally or
unintentionally that brings a change in process or in the process environment should not
affect the product quality or process characteristics.
• Location of the equipment is checked
• Checked for , if there is any need for the change of parts that have a direct effect on
equipment performance

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
• Sayed Imtiaz Haider, “pharmaceutical master validation plan”,published by
st.Luice press, volume 1 page no: 125.
• Berry I.R., & Nash R.A., “pharmaceutical process validation” second edition,
revised and expanded ; Marcel Dekker series 83-110.
• http://www.validationonline.net/Mixer.html
• Phil cloud, Pharmaceutical equipment validation-The ultimate qualification
guidebook, Interpharm /CRC press, Florida; 1998
• http://www.dipharma.com/Tousey_904T C.pdf
Bibliography

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