IPQC
Navin k khare

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 OBJECTIVES OF IN-PROCESS QUALITY CONTROL 5

 · To optimize the whole applied technological procedure.

 · To monitor control and improve effectively the whole
applied operations at the every stage of the

 finished pharmaceutical products.

 · Inspection of raw material, equipment, environment,
process, testing with respect to specification,

 packing and so on

 · Quality control & Process Control

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 IN PROCESS CHECKS SHALL INCLUDES FOLLOWING PROCESS CONTROLS
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 · Cleanliness of the area and line clearance
 · Checking of the status labels on the area and process containers.
 · Equipment/instrument: Calibration, verification and checking of the status labels.
 · Checking and verification of material used as Material Name, Material Code, Control

No. or A.R. No.
 · Time limits at all stages of process.
 · Checking of sieve/filter integrity.
 · Check vendor while goods are received and it should be according to approved vendor.
 · Online review of batch record at every stage of process.
 · Product attributes Like Weight, Hardness.
 · Verification of yield at various stages of manufacturing process.
 · Periodic check of control samples.
 · Measured values obtained from the room environment like Temperature, Humidity

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 AT MANUFACTURING OPERATION STAGE
 Weighing or measuring of active pharmaceutical ingredients, excipients, diluents or

vehicle should be done under the suitable conditions which do not affect their
conformity of use.

 Appropriate and calibrated equipment / instrument should be used for the above
purpose.

 Weighing, measuring, or subdividing operations should be done in presence of QA &
production authorized personnel.

 Prior to use in manufacturing process, IPQC & production personnel should verify
 all the materials against the batch manufacturing record. Materials should be

appropriately controlled to
 prevent unauthorized use. Following information being available on the label:-
 · Material Name, Material Code, Control No. or A.R. No
 · Weight or volume of material in the new container,
 · Re-test date if required.

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 Table -1: In-process Control Parameters
 Stage Control Variables
 Granulation
 Moisture, Blend Uniformity, Bulk & tapped Density,
 Particle size Distribution.
 Solid Oral Products
 (Tablets, Capsules)
 Appearance, Average Weight, Weight Variation, Hardness, Thickness, Friability, Disintegration
 Semi-solids Appearance, Viscosity, Homogeneity, pH,
 Liquids Oral Products Appearance, Clarity Of Solutions, pH, Specific Gravity, Weight Per mL
 Parenterals- Injectables
 (liquid-SVP & LVP)
 Appearance, Clarity, Fill Volume, pH,
 Filter Integrity Tests, Particulate Matter, Shape Of Container, Sealing Quality Of Container,
 Leak Testing Of Container, Pre-Filtration or Post-Sterilization, Bio-Burden Testing, Bacterial
 The

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 EndotoxinTests.
 Parenterals-Injectables
 (Dry powder Injection)
 Appearance, Clarity after reconstitution, Weight,
 Average weight, Weight variation, Particulate matter,
 Shape of container, Sealing quality of container, Leak testing of container.
 Dry powder inhalers
 Assay of API-excipient blend, Moisture,
 Weight variation of individually contained doses.
 Transversal dosage
 forms
 Assay of API-adhesive mixture, Weight per area of coated patch without backing.
 Metered dose inhalers Fill weight or volume, Leak testing, Valve delivery.
 Yield Verification with the set target at every stage

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 AT PACKING STAGE 5
 QA Personnel should give clearance for the finished dosage forms at all

the critical points of packing
 operation stages according to the written procedure.
 The packing of batch should be performed in following sequence:-
 · Check environmental monitoring it should be performed and record

must be maintained.
 · Check the area of cleanliness, all unwanted material of previous

batches should be absent.
 · Check that the blisters are free from knurling defects, strips for

alignment defects & empty pockets.
 · Check that the packing materials are received from approved vendors.
 ·

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 Check that the packing material should be tested by quality control dept and status
labels.

 · Check the status labels on equipment, area & in-process containers.
 · Check the Name, Strength, Volume and Composition on the printed packing material.
 · Check the over printing quality on the primary & secondary packing material
 · Check the Batch coding details on primary and secondary pack (B. No, Mfg. /date,

Exp. /date, M.R.P.
 /bar code, etc.)
 · Check the Text matter on the printed label, foil, carton & shipper etc.
 · Check the Pharmacopeia status of the material used in the preparation of product.
 · Check the Mfg. License number printed on the packing material.
 · Check the mandatory information printed according to drugs act and rules on pre-

printed packing
 materials.

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 · Check and confirm that the Storage condition details are
available in the packaging materials are

 according to particular product and same condition should be
available on all printed items.

 · Check the directions for use are available on the packaging
items and warnings or caution against

 wrong administration is provided in the packing items.
 · Ensure checkers are performing their activity in a proper

way.
 · Verify the records for online entries.
 · Sampling should be done according to SOPs.

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THANKS

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