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IN PROCESS QUALITY CONTROL SOLID DOSAGE FORMS BY PANDYA YOGI
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IN PROCESS QUALITY CONTROL TESTS FOR SOLID DOSAGE FORMS
• Guided By: Hiren Kadikar •Presented By: Yogi Pandya
ARIHANT SCHOOL OF PHARMACY &BIORESEARCH INSTITUTE
Department of Quality AssuranceM.Pharm. Sem: I
What Do You Mean By “IPQC”…?
IPQC is concerned with providing accurate , specific, & definite descriptions of the procedures to be employed, from, the receipt of raw materials to the release of the finished dosage forms.
“INSPECTION”
“TESTING”
SOLID DOSAGE FORMS
1.Tablets2.Capsules3.Powders
Effervescent Oral Insufflations Dentifrice Dusting
4.Lozenges
TABLETSTABLETS
Que: Is it easy to manufacture a “tablet” ?Ans: No…
Steps Of Tablet ManufacturingSteps Of Tablet Manufacturing
Weighing Screening Milling Mixing Granulation Blending Compression Packaging Labeling
Weighing Screening Milling Mixing Granulation Blending Compression Packaging Labeling
Quality Checks During ManufacturingQuality Checks During Manufacturing
IPQC Parameters to be measured
IPQC Parameters to be measured
I. Physical Parameters: a. temp
b. timec. particle size & textured. pressure mmH2Oe. weightf. hardnessg. thickness & diameterh. disintegrationi. dissolution ( % release)j. friabilityk. moisture content %relative humidity
I. Physical Parameters: a. temp
b. timec. particle size & textured. pressure mmH2Oe. weightf. hardnessg. thickness & diameterh. disintegrationi. dissolution ( % release)j. friabilityk. moisture content %relative humidity
Date Time Operation Room No.
Temp °C
%RH Diff. press (mm H2O)
signature
Dispensing 23 42 2.0
Sifting 48 1.8
Milling 2.0
Blending
Compression
Coating
BMR for Tab Mfg ProcessBMR for Tab Mfg Process
Parameter Limit Observation
Machine speed 20 rpm (15-25 rpm)
Wt. of 20 tabs 12.00g +2 (11.76-12.24g)
Theoretical weight/tab 600mg
Hardness 25Kg (20-30 Kg)
Thickness (av. of 10 tabs)
4.10mm +0.15mm (3.95 – 4.25mm)
Length 10mm + 0.1 mm (9.9 – 10.1 mm)
Width 5 mm + 0.1mm (4.9 – 5.1 mm)
Disintegration time NMT 15 mins
Wt. variation + 3% of Av. Wt.
Friability (10 tabs) NMT 1.0% w/w
Compression ParametersCompression Parameters
Parameter Frequency
Wt. of 20 tabs Every hour by production and every two hours by QA
Hardness, thickness, length, width
Every hour by production, every two hours by QA
Wt. variation Every half hour by production and every hour by QA
DT Every half hour by production, every hour by QA
IPQC checks frequency during mfg.IPQC checks frequency during mfg.
CAPSULES
CAPSULES
Steps Of Capsule Manufacturing
Steps Of Capsule Manufacturing
Mfg of Gelatin Shell.
Drying of shells in controlled humidity.
Mfg of granules/spanzules.
Filling of Shells.
Packaging & Labeling.
Mfg of Gelatin Shell.
Drying of shells in controlled humidity.
Mfg of granules/spanzules.
Filling of Shells.
Packaging & Labeling.
IPQC Checks During Gelatin Shell Manufacturing
IPQC Checks During Gelatin Shell Manufacturing
% purity of gelatin Viscosity of gelatin solution 25-45 millipoise Bloom strength of gelatin solution 150-250 gm Iron content NMT 15 ppm pH of gelatin A=9; B=4.7 Film Thickness Color, surface, appearance of empty shells Temperature of hot air, for drying of shells Length of Capsule & Body of the shell Moisture content 12-15%
% purity of gelatin Viscosity of gelatin solution 25-45 millipoise Bloom strength of gelatin solution 150-250 gm Iron content NMT 15 ppm pH of gelatin A=9; B=4.7 Film Thickness Color, surface, appearance of empty shells Temperature of hot air, for drying of shells Length of Capsule & Body of the shell Moisture content 12-15%
Sorting of defective shells
After the capsules have been inspected either electronically or manually, they are sampled by the QA inspector & checked for the defects and then sorted out.
Printing inspection on shell
Inspection of defects like:-• Hardening of shells• Softening of shells• Swelling of shells• Cracking of shells• Discoloration of shells • Misprinting of logo on shells
Sorting of defective shells
After the capsules have been inspected either electronically or manually, they are sampled by the QA inspector & checked for the defects and then sorted out.
Printing inspection on shell
Inspection of defects like:-• Hardening of shells• Softening of shells• Swelling of shells• Cracking of shells• Discoloration of shells • Misprinting of logo on shells
IPQC Checks During Filling Of Empty Capsule Shells
IPQC Checks During Filling Of Empty Capsule Shells
During filling process equipment should be labeledwith :-product name, Batch No, Time of starting, Sign
During Filling: flow property of granules or powders
Weight Variation : For hard gel caps-
Limit NMT 2 caps should deviate from avg wt.
AVG WT %DEVIATION <300mg 10% >300mg or more 7.5%
During filling process equipment should be labeledwith :-product name, Batch No, Time of starting, Sign
During Filling: flow property of granules or powders
Weight Variation : For hard gel caps-
Limit NMT 2 caps should deviate from avg wt.
AVG WT %DEVIATION <300mg 10% >300mg or more 7.5%
For soft gel caps:
•Wg 10 caps•Remove inner content by cutting with scissor/blade•Wash with solvent & evaporate solvent at room temperature for 30 min•Wg the empty shells & calculate % deviation
MACHINE OUTPUT INSPECTION:
•Machine output is monitored in a specific time interval•Total batch or number of caps filled are counted in a specific time interval & then machine is calibrated and speed is maintained.
For soft gel caps:
•Wg 10 caps•Remove inner content by cutting with scissor/blade•Wash with solvent & evaporate solvent at room temperature for 30 min•Wg the empty shells & calculate % deviation
MACHINE OUTPUT INSPECTION:
•Machine output is monitored in a specific time interval•Total batch or number of caps filled are counted in a specific time interval & then machine is calibrated and speed is maintained.
APPEARANCE:Inspection of capsules checked with a standard
strip
SORTING DEFECTS:Electronic automated or manual inspection is
made to sort out & reject the defected caps.
Overprinting
PRINTING & LABELING:Inspection of overprinting, logo, labeling are checked with the standard shade cards.Defective ones are sorted out & rejected.
APPEARANCE:Inspection of capsules checked with a standard
strip
SORTING DEFECTS:Electronic automated or manual inspection is
made to sort out & reject the defected caps.
Overprinting
PRINTING & LABELING:Inspection of overprinting, logo, labeling are checked with the standard shade cards.Defective ones are sorted out & rejected.
LOZENGESLOZENGES
Que- Are they different from Tablets?Ans- Yes..Que- Are they different from Tablets?Ans- Yes..
Steps For Manufacturing Of Lozenges
Steps For Manufacturing Of Lozenges
Weighing
Mixing
Sifting
Granulation
Moulding/Compression at low pressure
Packaging & Labeling
Weighing
Mixing
Sifting
Granulation
Moulding/Compression at low pressure
Packaging & Labeling
IPQC Checks During ManufacturingIPQC Checks During Manufacturing
Visual inspection
Shape, size, color
Weight variation
Overprinting logo
Uniformity
Disintegration
Packaging & Labeling
Visual inspection
Shape, size, color
Weight variation
Overprinting logo
Uniformity
Disintegration
Packaging & Labeling
POWDERSPOWDERS
Types Of PowdersTypes Of Powders
Effervescent powders
Dusting powders
Insufflations (Inhalers)
Dentifrice
Oral powders
Effervescent powders
Dusting powders
Insufflations (Inhalers)
Dentifrice
Oral powders
Flow Chart Of Powder Manufacturing
Flow Chart Of Powder Manufacturing
IPQC Checks During Powder Manufacturing
IPQC Checks During Powder Manufacturing
Particle size & shape Texture Powder flow Fluffiness Density Foreign Impurities Moisture Packaging - sealing, printing
Particle size & shape Texture Powder flow Fluffiness Density Foreign Impurities Moisture Packaging - sealing, printing
1. Effervescent Powders: sample powder in 250ml of water produces effervescence & dissolves in 12sec.
2.Dusting Powder:color, texture, density, particle size,
flow, fluffiness, spread ability
3.Insufflations: flow, particle size, density
4.Dentifrice:abrasion, texture, particle size, color
1. Effervescent Powders: sample powder in 250ml of water produces effervescence & dissolves in 12sec.
2.Dusting Powder:color, texture, density, particle size,
flow, fluffiness, spread ability
3.Insufflations: flow, particle size, density
4.Dentifrice:abrasion, texture, particle size, color
Powder Flow & Texture Analyzer
Powder Flow & Texture Analyzer
Powder Flow Analyzer used to measure:
Flow Texture Caking Cohesion Flow Speed Granule attrition Compaction & Relaxation Dusting Surface Friction Aggregation Air-entrapment Granulation
Powder Flow Analyzer used to measure:
Flow Texture Caking Cohesion Flow Speed Granule attrition Compaction & Relaxation Dusting Surface Friction Aggregation Air-entrapment Granulation
Parameters Measured:Parameters Measured:
(principle-slicing, shearing, compaction)• speed of rotor blade• blade angle• path of blade• resistance in speed and angle• axial force• time distance travelled
Measured by a sensitive transducer attached to rotor blades.
(principle-slicing, shearing, compaction)• speed of rotor blade• blade angle• path of blade• resistance in speed and angle• axial force• time distance travelled
Measured by a sensitive transducer attached to rotor blades.
REFERENCES:REFERENCES:
1. WHO Guidelines For Good ManufacturingPractices
2. Guidance For Industry: Nonsterile Dosage Forms; US Dept. of health & human services
3. Manohar A Potdar; current-Good Manufacturing Practices, Edn-2003.
4. D.H.Shah; standard operating procedures.5. Satish Maliya; WHO Guidelines; Issue-Jan-
19-22;2011.6. WHO public inspection report of finished
product manufacturing
1. WHO Guidelines For Good ManufacturingPractices
2. Guidance For Industry: Nonsterile Dosage Forms; US Dept. of health & human services
3. Manohar A Potdar; current-Good Manufacturing Practices, Edn-2003.
4. D.H.Shah; standard operating procedures.5. Satish Maliya; WHO Guidelines; Issue-Jan-
19-22;2011.6. WHO public inspection report of finished
product manufacturing
