This Powerpoint presentation summarizes in-process quality control (IPQC) procedures for pharmaceutical manufacturing. It discusses how IPQC monitors the manufacturing process from raw materials to finished products to ensure quality. Specific IPQC tests are described for different dosage forms like tablets, capsules, suspensions, and parenterals. Common problems encountered during manufacturing of these dosage forms are also outlined along with recommended troubleshooting steps. The importance of IPQC during packaging operations to check for defects is also highlighted.

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QUALITY ASSURANCE
IPQC
(IN PROCESS QUALITY
CONTROL)
PRESENTED BY
MANOJ KUMAR
(M.PHARM)

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IPQC
• IPQC is concerned with providing
accurate, specific and definite description
of the procedures to be employed from
the receipt of raw materials to the release
of the finished dosage form.
• IPQC is the activity performed between
QC and QA which involved-----

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To control the procedure involved in
manufacturing
 To maintain the quality of product.
To monitor all features which affect the
quality
 To detect errors when occurs by others.

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• IPQC
PHYSICAL/ BIOLOGICAL/
CHEMICAL
MICROBIOLOGICAL
Identity Quality Purity Potency
test test test test

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Identity Test- These tests are qualitative
chemical method used to confirm the actual
presence of compound. Eg- colour formation
, precipitation.
Quality test– These tests are physical method
used to measure accurate the characteristics
properties of drug .eg- absorbance,refractive
index.
Purity test- It is deigns to estimate the level of
all known and significant impurities and
contamination in the drug substances. Eg-
test for clarity of solution, acidity/alkalinity.

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Potency test- these tests always estimate the
quality of an active ingredient in drug.
Biological and microbiological - It included
macro and micro biological ways and test for
safety , toxicity , pyrogenicity , sterility,
antiseptic activities and antimicrobial
preservative effectiveness test.
Biological test of drug can be qualitative or
quantitative in nature .It involves the animals
preparation isolated by living tissues.

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OFFICIAL QUALITATIVE BIOLOGICAL
TEST
Product to be tests Test
1-Preperation of liver antianemia
Or stomach test
2-Antiseptics ,disinfectant antibacterial

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OFFICIAL QUANTITATIVE BIOLOGIC TEST-
Insuline Rabbits
Digitalis Pigeon
OFFICIAL QUALITATIVE MICROBIOLOGIC
Drug and D.S Test
organism
Calcium pentothenate Lactobacillus

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CONDITIONS FOR DESIGNING OF IPQC-
• Identify the types of formulation (tab , liquids,
ointments).
• Identify the critical steps involved in
manufacturing of the product.
• Identify the specification of parameters which
conform the parameters are within control.
• Define the frequency of checking for each
parameter.

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PURPOSE OF IPQC
• To ensure detectable and significance
human errors.
• Equipment failure
• Abnormal interpretation .
• Adoption of given procedure .

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IMPORTANCE OF IPQC
• To minimise human error.
• To accurate, specific, definite description of
the procesure to be employed.
• It is a planned system to identify material
equipment processes and operation.

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• To detect the error.
• To enforce the flow of manufacturing and
packaging operation according to established
route and practice.
• To pin point the responsibility.
• To detect any abnormality immediately.

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IPQC TESTS IN DIFFERENT
DOSAGE FORM
1- SOLID DOSAGE FORM

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TABLETS
• Wt. variation
• Hardness
• Thickness
• Friability
• Content uniformity
• Disintegration time
• Dissolution test
• Potency test
• Blister or strip sealing test

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CAPSULES
• Wt variation
• Assays
• Content uniformity
• Dissolution test
• Disintegration time
• Moisture content
• Bloom strength
• Iron test
• Hardness and flexibility of shell
• Loss on drying

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• Stability testing at different temperature
• Blister and strip sealing
SEMISOLID DOSAGE FORM

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SUSPENSIONS
• Appearance – colour , odour, taste
• Product is checked for uniform distribution of
colour absence of air bubbles
• Clarity
• Particles size of disperse phase
• Rheology
• QC of water being used
• Sedimentation volume
• Sedimentation rate

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• pH of different vehicles before and after
mixing
• Drug content
• Zeta potential mean
• Stability test
• Redispersibility
• Compatibility of product and
container/closure

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EMULSION
• Appearance-colour, odour, taste
• Drug content
• Rheology
• Stability
• Clarity
• QC of water to be used
• pH of different vehicles
• Compatibility of product/container/closure
• Breaking and cracking

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PARENTERALS
• pHpH
• Volume checkVolume check
• Clarity testClarity test
• Content uniformityContent uniformity
• Integrity of sealsIntegrity of seals
• Particulate matterParticulate matter
• Pyrogen testPyrogen test

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• Conductivity test
• Liquid loss test
• Fill volume test

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IDENTIFICATION OF PROBLEM
AND
TROUBLE SHOOTING
OF DIFFERENT DOSAGE
FORM
IN IPQC

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TABLETS
PROBLEMS TROUBLESHOOTING
PRECOMPRESSION
SLOWING TABLETING
CAPPING RATE
REDUCING
COMPRESSION

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REGRANULATION
PRESSURE ADJUSTMENT
LAMINATION REDUCE MACHINE
SPEED
ARRANGMENT OF DIES
AND PUNCHES

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REDUCING LIQUID
APPLICATION RATE
PICKING INCREASING AIR TEMP.
INCREASING DRY AIR
VOLUME

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REPLACE THE WARN OUT
PUNCHES AND DIES
CHIPPING
ADD POLISHING AGENTS
CHANGE SOLVENT SYSTEM
CHANGE BINDER SYSTEM
MOTTLING REDUCE THE DRYING
TEMP
GRIND TO A SMALL
PARTICLES SIZE

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PROPER ADJUSTMENT
HARDNESS BETWEEN THE UPPER
VARIATION AND LOWER PUNCH AT
THE MOMENT OF
COMPRESSION PROCESS
PROPER FLOW OF
WEIGHT GRANULES
VARIATION PROPER MIXING OF
LUBRICANTS AND
INGREDIENTS

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IMPROPER PROPER DIE FILLING
COMPRESSION PROCESS
FORCE
PREVENT UNNECESSARY
DOUBLE ROTATION OF LOWER AND
IMPRESSION UPPER PUNCHES
USE ANTITURING DEVICES

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POOR ADDITION OF GLIDANTS
FLOW
ATTACH VIBRATORS TO
THE HOPPER SIDE
ORANGE THINNING OF THE
PEEL SOLUTION WITH
EFFECT ADDITIONAL SOLVENTS
es THE PLASTILISERS
BRIDGING CONTENT
CHANGING PLASTICIZERS

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FILLING MONITORING OF FLUIDS
APPLICATION RATE
THROUGH MIXING OF
TABLETS
BLISTERING MILDER DRYING CONDITION
ADJUSTING PLASTICIZERS
CRACKING TYPE AND CONC.
PIGMENT TYPE AND CONC.

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CAPSULES
PROBLEMS TROUBLE SHOOTING
BRITTLENESS MAINTAINS OPTIMUM
MOITURE CONDITION
MAINTIANS OPTIMUM
UNUSUAL MOISTURE CONDITION
SOFTENING HUMIDITY RANGE-(30-40%)

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STABILITY OF ADJUST THE pH WITH
INGREDIENTS SMALL QUNTITY OF CITRIC
ACID,LACTIC ACID
,TARTARIC ACIDS
DISCOLORING USE CLEAR COLOURS
CHANGING TYPE OF
DARK SPOTS GELATINE SOLUTION OR
FILL MATERIALS
FORMULATION

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IMPROPER DO PROPER SEALING
SEALING
IMPROPER USE PROPER METHOD
LOCKING
UNSTABILITY
OF MIXED WITH SUITABLE
DRUGS INGREDIENTS

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EMULSION/SUSPENSION
PROBLEMS TROUBLE SHOOTING
REDUCING GLOBULES SIZE
REDUCING DIFFERENCE IN
CREAMING DENSITY B/W EXTERNAL
AND INTERNAL PHASE
INCREASING VISCOSITY

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ADD EMULSIFYING AGENT
CRACKING PREVENT DECOMPOSION
PPT OF EMULSIFYING
AGENTS
FLOCCULATION USE OF EMULGENTS

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MAINTANCE THE CONC.
OF INTERNAL PHASE B/W
PHASE (30-60%)
INVERSION STORE IN COOL PLACE
USE PROPER EMULGENT
IN ADEQUATE CONC.

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PARENTERAL
PROBLEM TROUBLE SHOOTING
LEAKAGE OF DO PROPER SEALING
AMPULES USE NEW AMPULES
PERFORATION CHANGE FILTER
IN FILTER
PARTICLES/DUST USE MEMBRANE
FILTER

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FIBRES USE MEMBRANE FILTER
pH USE BUFFER SOLUTION
LEACHING INTERNAL COATING OF
GLASS CONTAINER
LABELING USE SPECIFIC QTY OF
PROBLEM GUM

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IPQC DURING PACKAGING
• Line clearance must be given before starting
packaging operation.
• Directions given to operations people should
be easy and clear.
• Print details on labels must be certified.
• Leak testing bottles , ampoules , vials , must
be performed.

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• Details of measuring cups , spoons, droppers
etc must be checked.
• No. of unit strips , corton, bottles etc must be
checked.
• All directions related to quantity of sampling
and methods of sampling must be cleared.
• Results must be recorded in standard
formats.

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THANK
YOU