This document discusses quality control tests for solid dosage forms. It defines in-process quality control (IPQC) and describes various solid dosage forms including tablets, capsules, powders, and lozenges. For each type of dosage form, it outlines the manufacturing process and key IPQC checks to ensure quality. These include tests of physical properties, attributes, defects, specifications, and frequencies of monitoring parameters like weight, hardness, and disintegration during production.

1. 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.  Oral
◦ Tablets
◦ Capsules
◦ Solutions
◦ Syrups
◦ Elixirs
◦ Suspensions
◦ Magmas
◦ Gels
◦ Powders
 Sublingual
◦ Tablets
◦ Troches and Lozenges
 Parenteral
◦ Solutions
◦ Suspensions
 Conjunctival
◦ Contact lens inserts
◦ Ointments

4.  Epicutaneous /
transdermal
◦ Ointments
◦ Creams
◦ Infusion pumps
◦ Pastes
◦ Plasters
◦ Powders
◦ Aerosols
◦ Lotions
◦ Transdermal patches,
discs, solutions
 Intraocular/ intraaural
◦ Solutions
◦ Suspensions
 Intranasal
◦ Solutions
◦ Sprays
◦ Inhalers
◦ Ointments
 Intrarespiratory
◦ Aerosols

5.  Vaginal
◦ Solutions
◦ Ointments
◦ Emulsion foams
◦ Gels
◦ Tablets
◦ Inserts, suppositories,
sponges
 Rectal
◦ Solutions
◦ Ointments
◦ Suppositories
 Urethral
◦ Solutions
◦ suppositories

6.  Powders
◦ Blending Powders
◦ Medicated Powders
◦ Aerosolized Powders
 Granules
◦ Effervescent

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

8.  Powders
◦ Blending Powders
◦ Medicated Powders
◦ Aerosolized Powders
 Granules
◦ Effervescent

9.  Hard Gelatin Capsules
 Soft Gelatin Capsules

11.  Compressed tablets
(C.T.)
 Multiple Compressed
tablets (M.C.T.)
 Sugar-Coated Tablets
(S.C.T.)
 Film Coated Tablets
(F.C.T)
 Gelatin Coated Tablets
 Enteric Coated Tablets
(E.C.T.)
 Buccal or Sublingual
Tablets
 Chewable Tablets
 Effervescent Tablets
 Molded Tablets
 Immediate release
Tablets (I.R.)
 Instant Disintegrating
/Dissolving Tablets
 Extended release Tablets
(E.R.)

12.  Medicinal agent
 Diluents or filler
 Binders or
adhesives
 Disintergrants
 Lubricants
 Miscellaneous
adjuncts:
Colorants and flavorants

13. Compressed tablets Multiple Compressed tablets Sugar-Coated Tablets Film Coated Tablets
Gelatin Coated Tablets Enteric Coated Tablets

14.  Modified Release
 Extended Release
 Delayed Release
 Repeat action
 Targeted Release
 Terminology of
extended release
◦ Sustained Release (SR)
◦ Sustained Action (SA)
◦ Prolonged Action (PA)
◦ Controlled Release (CR)
◦ Extended Release (ER)
◦ Timed Release (TR)
◦ Long Acting (LA)

15. Extended Release

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

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

18. Quality Checks During Manufacturing

19. 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

20. II. Attributive Features:
a. visible impurities
b. color
c. elegance
d. completeness of product
f. Defects like…
• Excessive powder
• Pieces of tab
• Abrasions
• Cracks, chips, swelling, mottling,
fusion of tab..etc….
• Appearance of crystals on tab or
container.
g. Engraving/Embossing logo
h. Labeling & packaging

21. 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

22. 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

23. 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.

24. CAPSULES

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

26. 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%

27.  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

28. 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 %DEVIATION
<300mg 10%
>300mg or more 7.5%

29. 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.

30.  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.

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

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

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

34. POWDERS

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

36. Flow Chart Of Powder Manufacturing

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

38. 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

39. Powder Flow & Texture Analyzer

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

41. 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.

42. 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.
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