Here are 5 important in-process tests for pharmaceutical manufacturing:
1. Identity Testing
Verify the identity of raw materials, intermediates, and finished products.
Tests:
– FTIR (Fourier Transform Infrared Spectroscopy)
– HPLC (High-Performance Liquid Chromatography)
– GC (Gas Chromatography)
– UV-Vis Spectroscopy
2. Moisture Content Testing
Measure the moisture content of raw materials, intermediates, and finished products.
Tests:
– Karl Fischer Titration
– Loss on Drying (LOD)
– Thermogravimetric Analysis (TGA)
3. Particle Size Distribution (PSD) Testing
Determine the particle size distribution of powders and granules.
Tests:
– Sieve Analysis
– Laser Diffraction
– Dynamic Light Scattering (DLS)
4. Friability Testing
Measure the friability (ability to withstand abrasion) of tablets.
Tests:
– Friability Test Apparatus
– Abrasion Test
5. Hardness Testing
Measure the hardness (crushing strength) of tablets.
Tests:
– Tablet Hardness Tester
– Crushing Strength Test
Additional important in-process tests:
– Weight Variation Test
– Disintegration Testing
– Dissolution Testing
– pH Testing
– Viscosity Testing
Regulatory guidelines:
– USP <111> “Sterility Tests”
– USP <671> “Tablet Friability”
– USP <724> “Tablet Hardness”
– Ph. Eur. 2.9.3 “Disintegration of Tablets and Capsules”
– ICH Q2 (R1) “Validation of Analytical Procedures”
Understanding these in-process tests helps ensure product quality, safety, and efficacy.
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