IPQC solid dosage forms

1. Dr. Mamta
Department Of Pharmacy Practice
IN PROCESS QUALITY CONTROL TESTS
FOR SOLID DOSAGE FORMS

2. 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”

3. SOLID DOSAGE FORMS
• Tablets
• Capsules
• Powders
 Effervescent
 Oral
 Insufflations
 Dentifrice
 Dusting
4.Lozenges

4. TABLETS
Que: Is it easy to manufacture a “tablet” ?
Ans: No…

5. Steps Of Tablet Manufacturing
 Weighing
 Screening
 Milling
 Mixing
 Granulation
 Blending
 Compression
 Packaging
 Labeling

6. Quality Checks During Manufacturing

7. IPQC Parameters to be measured
I. Physical Parameters:
a. temp
b. time
c. particle size & texture
d. pressure mmH2O
e. weight
f. hardness
g. thickness & diameter
h. disintegration
i. dissolution ( % release)
j. friability
k. moisture content %relative humidity

9. 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 Process

10. 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 Parameters

11. 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.

12. CAPSULES

13. Steps Of Capsule Manufacturing
 Mfg of Gelatin Shell.
 Drying of shells in controlled humidity.
 Mfg of granules/spanzules.
 Filling of Shells.
 Packaging & Labeling.

14. 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%

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

16. IPQC Checks During Filling Of Empty
Capsule Shells
 During filling process equipment should be labeled
with :-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
<300mg
>300mg or more
%DEVIATION
10%
7.5%

17. 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.

18.  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.

19. LOZENGES
Que- Are they different from Tablets?
Ans- Yes..

20. Steps For Manufacturing Of Lozenges
 Weighing
 Mixing
 Sifting
 Granulation
 Moulding/Compression at low pressure
 Packaging & Labeling

21. IPQC Checks During Manufacturing






 Visual inspection
Shape, size, color
Weight variation
Overprinting logo
Uniformity
Disintegration
Packaging & Labeling

22. POWDERS

23. Types Of Powders
 Effervescent powders
 Dusting powders
 Insufflations (Inhalers)
 Dentifrice
 Oral powders

24. Flow Chart Of Powder Manufacturing

25. IPQC Checks During Powder
Manufacturing
 Particle size & shape
 Texture
 Powder flow
 Fluffiness
 Density
 Foreign Impurities
 Moisture
 Packaging
- sealing, printing

26. 1. Effervescent Powders:
sample powder in 250ml of water produces
effervescence & dissolves in 12sec.
5.Dusting Powder:
color, texture, density, particle size,
flow, fluffiness, spread ability
8.Insufflations:
flow, particle size, density
11.Dentifrice:
abrasion, texture, particle size, color

27. Powder Flow & Texture Analyzer

28. Powder Flow Analyzer used to measure:
 Flow
 Texture
 Caking
 Cohesion
 Flow Speed
 Granule attrition
 Compaction & Relaxation
 Dusting
 Surface Friction
 Aggregation
 Air-entrapment
 Granulation

29. 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.

30. REFERENCES:
1. WHO Guidelines For Good Manufacturing
Practices
2. Guidance For Industry: Nonsterile Dosage
Forms; US Dept. of health & human services
3. Manohar A Potdar; current-Good Manufacturing
Practices, Edn-2003.
Jan-19-22;2011.
• D.H.Shah; standard operating procedures.
• Satish Maliya; WHO Guidelines; Issue-
• WHO public inspection report of finished
product manufacturing