The document outlines the validation and qualification processes for tablet compression machines and capsule filling machines in the pharmaceutical industry, emphasizing the importance of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) to ensure equipment operates correctly and produces quality products. It details the objectives and checklist items for each qualification stage, including checks for tooling, operational parameters, and physical characteristics of tablets or capsules. The document serves as a guide for ensuring compliance with regulatory requirements while assessing and maintaining production standards.

1. PRESENTED BY : YASH R.MENGHANI
M.PHARM 1st YEAR (SEMISTER II)
SMT.KISHORITAI BHOYAR COLLEGE OF
PHARMACY,KAMPTEE
1

2. INTRODUCTION :
 VALIDATION : Action of proving and documenting that
any process, procedure or method actually and
consistently leads to the expected results.
&
 QUALIFICATION : Action of proving and documenting
that any premises, systems and equipment are properly
installed, and/or work correctly and lead to the expected
results. The term qualification is normally used for
equipment, utilities and systems, and validation for
processes
 In this sense, qualification is part of validation.
2

3. TABLET COMPRESSION MACHINE:
 A tablet press is a mechanical device that compresses
powder into tablets of uniform size and weight.
 Tablet Compression Machine is also known as Tablet
Press in Pharmaceutical Industry which is used to make
the tablets according to a pre-determined design.
 Compression is a critical step in the production of a
tablet dosage form. The materials being compressed will
need to have adequate flow and compression properties.
 Factors to be considered during compression are,
 Tooling
 Compression speed
3

4. 4

5. TOOLING :
 Tablet compression machines are made in keeping the
view of the type of dies and punches will be used on them,
 The dies and punches and their setup on compression
machine is called tooling.
 The shape ,size and as well as certain identification
markings are determined by compression machine
tooling.
 Each tooling set consist of dies , upper and lower punches.
 Production efficiency, dosage uniformity and appearance
depend upon tooling set.
5

6.  Punches :
Length:
Upper punch - 5.25 inches
Lower punch - 3 inches.
Barrel diameter- 0.75 inches.
Head diameter- 1 inch
 D tooling : Is popular for large tablets
Punch:
Length- 5.25 inch
Head diameter- 1.25 inch
Barrel diameter- 1 inch
Dies :
out side diameter – 0.945 inch are used
6

7. VALIDATION :
 DESIGN QUALIFICATION
 INSTALLATION QUALIFICATION
 OPERATIONAL QUALIFICATION
 PERFORMANCE QUALIFICATION
7

8. INSTALLATION QUALIFICATION (IQ):
 Verify approved purchase order.
 Check manufacturer and supplier .
 Verify Model number and serial number.
 Check any physical damage.
 Confirm location and installation requirements as per
recommendation of manufacturer .
 Verify that the required utilities are available.
 Installation shall be conducted per instructions provide in
the manual.
OBJECTIVE OF IQ
 To check all the critical contacts parts which directly affect
quality of the product.
 To review proper installation as per checklist.
8

9. IQ CHECK LIST:
Compare all specification and write the observation
 Machine height – measure with measuring tape.
 Overall dimension- measure with measuring tape
 Rpm of turret – check by tachometer.
 Hopper :
i)Conventional hopper- by visual check
ii)MOC(master of construction )-using Molybdenum
iii)Height- Measure with measuring tape
 No. of station- visually count no.of holes on turret.
 Type of tooling- using venire caliper check the die hole
diameter .
 Feeder- by visual check.
9
Continue…

10.  Required utilities-electricity.
 Thickness controller cam
 Weight of controller cam
 Main drive :
i) ON indicator
ii) Potentiometer
iii) Selector Switch
iv) Emergency switch
 Dust extraction and exhaust system
 Lubrication
i) Oil pressure gauge
ii) Select switch for auto/manual
10
By Visual
check

11. OPERATIONAL QUALIFICATION (OQ ):
 Verify alarm control.
 Perform calibration requirements, identify in the
manual or established by the validation team.
 Operate the equipment at low medium and high speed
as per operation manual to verify the operation
control.
 Verify that all switches and push buttons are
functioning properly
 Establish procedures for operation, maintenance and
calibration
 Establish training program for relevant staff Run one
pilot batch for each product
11

12.  Objective of OQ :
 To operate machine as per proposed procedure given in
manual and record.
 To challenge the operating parameter of machine and
record.
 To challenge the safety operation and record.
12

13. OQ CHECK LIST:
1) Main switch- check visually by operating the main
switch of the machine.
2) Start push button- illuminated green switch By
pressing start button the green switch glows and the main
drive motor should start.
3) stop push button- illuminated red switch By pressing
stop button the red switch glows and the main drive
motor should stop
4) Turret RPM challenge test- set in the digital table
counter by rotating knob check by tachometer Rotation
direction (clockwise ) by visual check
13
Continue…

14. OQ CHECK LIST:
5) Emergency switch by visual check .
6)Tablet thickness & Hardness controls : By turning the swing
lever to right/left thickness increased hardness/decrease vise
versa
7) Machine speed adjustment : Release the locking knob and
rotate the hand wheel anticlockwise /clock wise- increased
speed/decreased speed
8) Main upper punch entry: Remove the bolt and rotate the
perforated segment to right/ left-upper punch penetration
increases/ decreases.
14

15. PERFORMANCE QUALIFICATION (PQ):
 Its an Evaluation of compression capabilities and tablet
characteristics.
 The compression capabilities and tablet characteristics are:
1) Content uniformity
2) Thickness
3) Hardness
4) Friability
5) weight variation
6) Disintegration test.
should be investigated.
15

16. OBJECTIVE OF PQ :
 First three batches of biliary and single layer product to
be compressed on given compression machine.
 All the critical physical parameters of product will be
checked during performance qualification.
 Measure the thickness, hardness, friability and weight
for each triplicate tablet run, as shown below
16

17.  CONTENT UNIFORMITY :
- Select 30 tablets randomly from batch
- Assay individually
 ACCEPTANCE CRITERIA:
- Out of 30 tablets 3 tablets can be with in 75 – 125% and
all tablets should be with in 85 -115%
 THICKNESS :
- First 20, last 20, middle 20 tablets (throughout the run)
Determine mean and standard deviation.
 ACCEPTANCE CRITERIA:
- The Relative Standard Deviation should be less than or
equal to 5%
17

18.  HARDNESS :
- First 20, last 20, middle 20 tablets (throughout the run)
Determine mean and standard deviation for baseline
 ACCEPTANCE CRITERIA :
- Must meet each tablet specifications.
Chewable tablets- 3kg/cm2
Tablets- 4-8kg/cm 2
sustained release tablets & troches- 10-20kg/cm 2
 FRIABILITY:
- First 20, last 20, middle 20 tablets
% friability =( initial wt - final wt / initial wt )
 ACCEPTANCE CRITERIA:
- Weight loss less than or equal to 1%, per USP
18

19.  WEIGHT VARIATION:
20 - TABLETS
% weight variation= (individual wt-avg wt/ avg wt) x 100
 ACCEPTANCE CRITERIA :
For Average Weight 130 mg or less 10% difference
For Average Weight 130 to 324 mg 7.5% difference
For Average Weight More than 324 mg 5% difference
Not more than two tablets have a variation as large as
shown here.
19

20.  DISINTEGRATION TEST :
It is the process of breakdown of tablet into smaller
particles
20
TABLETS DISINTEGRATION TIME
Uncoated
Plain Coated
Enteric Coated
Dispersible
Effervescent
Sublingual
Buccal
15 min
60 min
3 hrs
3 min
More than 3 min
4 hrs
4hrs

21. ACCEPTANCE CRITERIA:
 All tablets have disintegrated completely.
 If 1 or 2 tablets fails to disintegrate completely repeat
the test for 12 additional tablets.
21

22. VALIDATION/QUALIFICATION OF CAPSULE
FILLING MACHINE
Installation Qualification(IQ)
The Installation Qualification will confirm
details from
 the engineering specifications,
 equipment purchase order
 cGMP guidelines and requirements,
verify that the equipment has been installed
as specified by the vendor
22

23. Purchase Details :
 The purchase order no. date shall be checked
 The accessories their spare parts if any shall
be checked as per purchase order
 The delivery period shall be as per purchase
order
 Supplier or manufacturer name address shall be
checked
 Any deviation observed should be informed to the
supplier or manufacturer
23

24.  Details of the Equipment :
 Equipment name, make model no. shall be
recorded
 In-house identification no. shall be recorded
 Location for installation shall be checked
 Utilities required shall be listed down
 A detailed specification must be written which highlight
those parts of machine that are in
product contact
 Where stirring devices or augers are used to ensure
homogeneity and improve flow then specification of
these parts must be checked
24

25.  Acceptance Criteria For IQ :
 Fulfill the selection criteria its purpose of
Application
 The equipment shall be as per purchase order
 Accessories received shall be as per purchase
order
 Should meet pre-selected design parameters
 Manufacturer/supplier shall provide complete
equipment manual
 Material of construction shall be as per purchase order
25

26. Operational Qualification (OQ)
 Before initiating OQ ensure that SOP for operation and
Cleaning of Capsule Filling Machine is available.
 Purpose is to train the qualification team for
performing OQ
Procedure :
 Check all the dynamic attributes of the capsule filler
conform to the required specifications
 Initiate the actual operation of the equipment to ensure that
machine is operate within the desired rate of output.
 The operation of indicators, controls and alarms is verified
 Oil leaks that could contaminate the process are observed
26

27. Acceptance criteria For OQ :
 All operating inputs provided on the equipment
when tested shall-successfully comply
-meet tolerance limit
 The equipment should successfully perform when
operated as per SOP
 Critical alarm/indicators provided on the
equipment-
-calibrated
 The equipment when operated shall not
- produce abnormal sound
- show any discrepancy in its smooth
operation.
27

28. Performance Qualification(PQ)
 PQ activities demonstrates and documents that the
equipment is able to perform its intended functions
within the variable process limits for a specific product
 Acceptance criteria are developed according to the
regulatory requirements and production parameters
 To ensure that the quality and purity of the
product is maintained
 The PQ will also test the extremes of the operation, or the
peak load conditions, but it does not include testing to
failure.
28

29.  Procedure :
 Record the number of damaged capsules
 Capsules from throughout the lot/different batches
should be tested for weight uniformity
 Capsules from throughout the lot/different batches
should be tested for blend content uniformity
 Production speed i.e capsule per minute should be
evaluated
29

30. THANK
YOU !
30