In Process Process Quality Control in Pharmaceuticals
In Process Process Quality Control in Pharmaceuticals
In Process Process Quality Control in Pharmaceuticals
Control
in
Pharmaceuticals
The quality of drugs and manufactured
pharmaceutical products can be achieved at
the level of predetermined specification by
testing each and every steps of
manufacturing, not after its formulation.
• Quality Assurance: The measure are to be taken at
all stage of product design, development and
production to ensure quality (zero defect) of a
product.
• TABLETS
• CAPSULES
• PARENTRALS
• LIQUID
• SEMISOLID
• PACKAGING LINE
IPQC FOR TABLETS
1. Environmental control:
a. Filter condition and changes, humidity and temperature
monitoring.
b. Water releases sticker at point of use for chemical and
microbial parity.
2. Materials:
c. Checking for name, lot no., weight, particle size, bulk density,
colour and water content.
d. Balances and scales, sifter and granulator and multimill with
screen.
3. Mixing/Massing:
• CAPPING
• LAMINATION
• PICKING
• STICKING
• MOTTELING
• WEIGHT VARIATION
• POOR FLOW
• POOR MIXING
• HARDNESS VARIATION
• DOUBLE IMPRESSION
IPQC TEST OF CAPSULES
• ASSAY
• WEIGHT VARIATION TEST
• DISINTEGRATION TIME
• DISSOLUTION TIME
• LEAK TEST
• MOISTURE TEST
• BLOOM STRENGTH
• IRON TEST
• HARDNESS OR FLEXYBILITY OF SHELL
• LOSS ON DRYING
• STABILITY TEST AT DIFFERENT TEMPERATURE
IPQC PROBLEMS OF CAPSULES
• BRITTLENESS
• UNUSUAL SOFTNING
• STABILITY OF INGRADIENTS (SOFT GELATION)
• COLOR FADING /DISCOLORISING
• DARKNING OR WIDENING OF CAPSULES
• APPEARANCE OF DARK (SOFT) SPOT
• IMPROPER SEALING
• IMPROPER LOCKING
• IMPROPER MIXING
• UNSTABILITY OF INGRADIENT
IPQC TESTS OF LIQUID DASAGE FORM
• STANDARDS OF PURIFIED WATER
• RAW MATERIAL TEST
• VISCOSITY TEST
• COLOR, ODOUR,CONSISTANCY NEED TO BE CHECKED
• PH OF LIQUID DOSAGE FORM IS CHECKED BEFORE AND AFTER
FILLING
• CHEMICAL AND PHYSICAL STABILITY CONTROL
• CONTAINER BEAR A APPROVED LABLE
• MOISTURE CONTENT IN RAW MATERIALS
• COUNTER CHECKING DONE
• CHECK THE PHYSICAL DESCRIPTION OF FINAL PRODUCT
• PHYSICAL DESCRIPTION OF FINAL PRODUCT MUST MEET
STANDARDS
• INTERMITTENTLY FILLED VOLUME IS CHECKED AT 30 MIN INTERVAL
IPQC PROBLEM IN LIQUID DOSAGE FORM
5. Checking
Each filled vial and ampoules subjected to
inspection for particles, volume, cap or seal
condition.
IN-PROCESS QUALITY CONTROL TEST OF PARENTRAL
1. ASSAY
2. CLARITY:
A. VISUAL EXAMINATION
B. COULTER COUNTER METHOD
C. FILTRATION METHOD
D. LIGHT BLOCKAGE METHOD
3. LEAKAGE TEST
E. DYE BATH TEST
F. LIQUID LOSS TEST
G. HIGH VOLTAGE DETECTOR
H. SPARK TEST
4. STERILITY TEST
I. MEMBRANE FILTRATION METHOD
J. DIRECT INNOCULATION METHOD
5. PYROGEN TESTING (SHAM TEST)
6. WATER ATTACK TEST
7. POWDER GLASS TEST
8. PH
9. LABELING CHECKING
10. AREA, EQUIPMENT, MATERIAL TEST
11. THIXOTROPHY TEST
12. PASSABILITY OF PARENTRAL PRODUCT FROM NEEDLE
13. COMPATIBILITY OF PRODUCT WITH GLASS CONTAINER
14. VOLUME THAT IS TO BE FILLED (EITHER OVERFILLED OR UNDERFILLED)
15. CONDUCTIVITY TEST
16. PRESERVATIVE CHALLENGE TEST
17. STABILITY TEST
IPQC PROBLEMS IN PARENTRALS
1. FOREIGN PARTICLES/ DUST
2. FIBERS
3. PARTICULATE MATTER
4. PH
5. LEAKAGE OF AMPULE
6. PERFORATION IN FILTER LEADING TO DEFECTIVE
FILTRATION
7. CROSS CONTAMINATION
8. LEACHING
9. LABELING PROBLEM
IPQC CHECKS ON PACKING LINE
1. STRIPS- NUMBER OF STRIP
APPEARANCE OF STRIPS
TEXT OF STRIPS
CODE NUMBER
2. CARTONS- BATCH NUMBER
OVERPRINTED TEST
3. SHIPPER – NUMBER OF CARTONS IN SHIPPER
PRINTED MATTER
CONSIDER THE FOLLOWING EXAMPLES QUALITY VARIATION