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

INTRODUCTION :
2
⚫VALIDATION : Action of proving and documenting that
any process, procedureor method actually and
consistently leads to theexpected results.
&
⚫QUALIFICATION : Action of proving and documenting
that any premises, systems and equipment are properly
installed, and/orwork correctlyand lead to theexpected
results. The term qualification is normally used for
equipment, utilities and systems, and validation for
processes
⚫In this sense, qualification is partof validation.

TABLET COMPRESSION MACHINE:
3
⚫A tabletpress is a mechanical device thatcompresses
powder into tabletsof uniform size and weight.
⚫Tablet Compression Machine is also known as Tablet
Press in Pharmaceutical Industrywhich is used to make
the tabletsaccording toa pre-determined design.
⚫Compression is a critical step in the production of a
tabletdosage form. The materials being compressed will
need to haveadequate flow and compression properties.
⚫Factors to beconsidered during compression are,
 Tooling
 Compressionspeed

4

TOOLING :
5
⚫Tablet compression machines are made in keeping the
view of the typeof diesand puncheswill be used on them,
⚫Thedies and punchesand theirsetupon compression
machine is called tooling.
⚫The shape ,size and as well as certain identification
markings are determined by compression machine
tooling.
⚫Each tooling setconsistof dies , upperand lowerpunches.
⚫Productionefficiency, dosage uniformityand appearance
depend upon tooling set.

⚫Punches :
Length:
Upperpunch - 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

VALIDATION :
7
⚫DESIGN QUALIFICATION
⚫INSTALLATION QUALIFICATION
⚫OPERATIONAL QUALIFICATION
⚫PERFORMANCE QUALIFICATION

INSTALLATION QUALIFICATION (IQ):
8
⚫Verifyapproved purchaseorder.
⚫Check manufacturerand supplier .
⚫Verify Model numberand serial number.
⚫Check any physical damage.
⚫Confirm location and installation requirementsas per
recommendation of manufacturer .
⚫Verify that the required utilitiesareavailable.
⚫Installation shall be conducted per instructions provide in
the manual.
OBJECTIVE OF IQ
⚫Tocheck all thecritical contacts parts which directlyaffect
qualityof the product.
⚫To review proper installation as perchecklist.

IQ CHECK LIST:
9
Compareall specification and write theobservation
⚫Machine height – measurewith measuring tape.
⚫Overall dimension- measurewith measuring tape
⚫Rpm of turret – check by tachometer.
⚫Hopper :
i)Conventional hopper- by visual check
ii)MOC(masterof construction )-using Molybdenum
iii)Height- Measurewith measuring tape
⚫No. of station- visuallycount no.of holes on turret.
⚫Typeof tooling- using venire calipercheck thedie hole
diameter .
⚫Feeder- byvisual check.
Continue…

⚫Required utilities-electricity.
⚫Thickness controllercam
⚫Weightof controllercam
⚫Main drive :
i) ON indicator
ii) Potentiometer
iii) SelectorSwitch
iv) Emergency switch
⚫Dustextraction and exhaustsystem
⚫Lubrication
i) Oil pressuregauge
ii) Selectswitch forauto/manual
By Visual
check
10

OPERATIONAL QUALIFICATION (OQ ):
11
⚫Verify alarm control.
⚫Perform calibration requirements, identify in the
manual orestablished by thevalidation team.
⚫Operate theequipmentat low mediumand high speed
as per operation manual to verify the operation
control.
⚫Verify thatall switchesand push buttonsare
functioning properly
⚫Establish procedures foroperation, maintenanceand
calibration
⚫Establish training program forrelevantstaff Runone
pilot batch foreach product

⚫Objectiveof OQ :
⚫Tooperate machineas per proposed proceduregiven in
manual and record.
⚫Tochallenge theoperating parameterof machineand
record.
⚫Tochallenge the safetyoperation and record.
12

OQ CHECK LIST:
13
1)Main switch- check visually byoperating the main
switchof the machine.
2)Start push button- illuminated green switch By
pressing start button thegreen switchglowsand the main
drive motorshould start.
3)stoppush button- illuminated red switch By pressing
stop button the red switch glows and the main drive
motorshould stop
4)Turret RPM challenge test- set in the digital table
counterby rotating knobcheck by tachometer Rotation
direction (clockwise ) byvisual check
Continue…

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

PERFORMANCE QUALIFICATION (PQ):
15
⚫Its an Evaluation of compression capabilitiesand tablet
characteristics.
⚫Thecompression capabilitiesand tabletcharacteristics are:
1) Content uniformity
2) Thickness
3) Hardness
4) Friability
5) weightvariation
6) Disintegration test.
should be investigated.

OBJECTIVE OF PQ :
16
⚫First three batchesof biliary and single layerproduct to
becompressed on given compression machine.
⚫All thecritical physical parameters of productwill be
checked during performance qualification.
⚫Measure the thickness, hardness, friabilityand weight
foreach triplicate tabletrun, as shown below

⚫CONTENT UNIFORMITY :
- Select 30 tablets randomly from batch
- Assay individually
⚫ACCEPTANCE CRITERIA:
- Outof 30 tablets 3 tabletscan be with in 75 – 125% and
all tablets should bewith 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

⚫HARDNESS :
- First 20, last 20, middle 20 tablets (throughout the run)
Determine mean and standard deviation for baseline
⚫ACCEPTANCE CRITERIA :
-Must meeteach 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 orequal to 1%, per USP
18

⚫WEIGHTVARIATION:
20 - TABLETS
% weightvariation= (individual wt-avg wt/ avg wt) x 100
⚫ACCEPTANCE CRITERIA :
ForAverage 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 haveavariationas largeas
shown here.
19

⚫DISINTEGRATION TEST :
It is the processof breakdownof tablet into smaller
particles
20
TABLETS DISINTEGRATION TIME
Uncoated 15 min
Plain Coated 60 min
Enteric Coated 3 hrs
Dispersible 3 min
Effervescent More than 3 min
Sublingual 4 hrs
Buccal 4hrs

ACCEPTANCE CRITERIA:
⚫All tablets havedisintegrated completely.
⚫If 1 or 2 tablets fails todisintegratecompletelyrepeat
the test for 12 additional tablets.
21

VALIDATION/QUALIFICATION OF CAPSULE
FILLING MACHINE
22
Installation Qualification(IQ)
The Installation Qualification will confirm
details from
⚫theengineering specifications,
⚫equipment purchaseorder
⚫cGMP guidelines and requirements,
verify that theequipment has been installed
as specified by thevendor

Purchase Details :
⚫The purchaseorder no. date shall be checked
⚫The accessories theirspare parts if any shall
bechecked as perpurchaseorder
⚫Thedelivery period shall beas perpurchase
order
⚫Supplieror manufacturer nameaddress shall be
checked
⚫Anydeviation observed should be informed to the
supplieror manufacturer
23

⚫Detailsof the Equipment :
⚫Equipment name, make model no. shall be
recorded
⚫In-house identification no. shall be recorded
⚫Location for installationshall be checked
⚫Utilities required shall be listed down
⚫A detailed specification must bewritten which highlight
thosepartsof machine thatare in
productcontact
⚫Where stirring devicesoraugers are used toensure
homogeneityand improve flow then specification of
these parts must be checked
24

⚫Acceptance Criteria ForIQ :
⚫Fulfill the selection criteria its purposeof
Application
⚫Theequipmentshall beas per purchaseorder
⚫Accessories received shall be as perpurchase
order
⚫Should meetpre-selected design parameters
⚫Manufacturer/suppliershall providecomplete
equipment manual
⚫Material of constructionshall beas perpurchaseorder
25

Operational Qualification (OQ)
26
⚫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

Acceptance criteria For OQ :
27
⚫All operating inputs provided on theequipment
when tested shall-successfully comply
-meet tolerance limit
⚫Theequipmentshould successfully performwhen
operated as per SOP
⚫Critical alarm/indicators provided on the
equipment-
-calibrated
⚫Theequipmentwhen operated shall not
- produceabnormal sound
- show anydiscrepancy in its smooth
operation.

Performance Qualification(PQ)
28
⚫PQ activities demonstrates and documents that the
equipment is able to perform its intended functions
within thevariable process limits fora specific product
⚫Acceptance criteria are developed according to the
regulatoryrequirementsand production parameters
⚫To ensure that thequalityand purityof the
product is maintained
⚫The PQ will also test theextremesof theoperation, or the
peak load conditions, but it does not include testing to
failure.

⚫Procedure :
⚫Record the numberof damaged capsules
⚫Capsules from throughoutthe lot/different batches
should be tested forweight uniformity
⚫Capsules from throughout the lot/different batches
should be tested for blend contentuniformity
⚫Production speed i.ecapsuleper minuteshould be
evaluated
29

THAN
K
YOU !
30