In Process Process Quality Control in Pharmaceuticals

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In process Process Quality

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.

• Quality Control: is a part of quality assurance which


concerned with sampling , testing, and monitoring
to established that pharmaceutical product confirm
to specifications.
IN PROCESS QUALITY CONTROL

• Concerned with providing accurate, specific


and definite description of product to be
employed from the raw material of finished
product.
IMPORTANCE OF I.P.Q.C.

1. To Minimise the human errors


2. To Provide accurate, specific and definite description of the
procedure to be employed
3. To identify materials, equipments, processes and operations
4. To detect the errors if and when it does occur
5. Corrective action instituted by people
6. To pin point the responsibility
7. To enforce the flow of manufacturing and packaging operations
according to established routes and practice
8. To be rigidly followed
9. Detect any abnormality immediately
OBJECTIVE
• Several tests, checks and measurements need
to be made during the course of manufacture
including packaging, to ensure that the
resultant product will comply with its desired
specification.
• Test applied to the environment or to
equipment as well as to products in process
may also be regarded as a part of in-process
quality control.
SCOPE

In-process controls are particularly important


where a process may vary with time such as
tablet weights, fill volume, head space gasses
etc.
IN-PROCESS QUALITY CONTROL TESTS

• 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:

1. Checking for proper equipment and addition


of ingredients, mixing time and sampling
from top, middle and bottom.
2. Checking of binder temp., rate and addition
time
3. Massing time and load reading
4. Wet milling, speed, screen, equipment
checking
4. Drying:

1. Cleaning condition of an equipment and filter bag


2. Separate bag for each
3. Loading uniformity, air temp, outlet temp, time of
drying
4. Moisture control and determination
5. Proper sifting and control of oversize granules
6. Fine collection and lubrication
7. Proper mixing for specified product.
IPQC TESTS OF TABLETS

• WEIGHT VARIATION OF TABLETS


• HARDNESS OF TABLETS
• THICKNESS
• FRIABILITY
• UNIFORMITY OF CONTENT
• DISINTEGRATION TIME
• POTENCY – ASSAY
• DISSOLUTION TEST
• BLISTER SEALING TEST
• CONTENT OF ACTIVE INGREDIENTS
IPQC PROBLEM FOR TABLET

• 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

• AFFECTED FROM SUNLIGHT


• OFFENSIVE ODOUR
• CHANGE IN CONSISTENCY
• PH CHANGE
• VISCOSITY
• LEAKAGE
• ERROR IN LABEL INFORMATION
• VOLUME VARIATIONS
IPQC TEST OF SEMISOLIDS
• FILL VOLUME TEST
• SEALING TEST
• POTENCY ASSAY
• VISCOSITY
• PH
• PROPER LABELING
• UNIFORMITY OF CONTENT
• CONCENTRATION OF ACTIVE INGRADIENT
• LOSS ON DRYING
• COMPATIBILITY TO SKIN AND OTHER BODY PARTS
PROBLEMS IN SEMISOLIDS
1. CREAMING
2. CRACKING
3. FLOCULATION
4. COALESENCE
5. PHASE INVERSION
IPQC FOR PARENTRAL PRODUCT
The in-process control depend on the
complexity of the product. The production line
for Parentral manufacturing of the following
steps:
1. Material, Equipment and Area
2. Filling
3. Sterilisation
4. Leak testing
5. Checking
1. Material, Equipment and Area
1. Checking of material for name, lot no., vendor, weighing components
2. Addition should be marked, record
3. Checks for potency, date
4. Equipment labelled with name of product, lot no.
5. Proper cleaning from its last usage
6. Cleaning tag with signature of the responsible persones
7. Temperature 72 +_ 5 F
8. Humidity 40 % RH
9. Room outlet for air , absolute filter 0.3 M
10.Gauge across the filters
11.18-20 air change/hr
12.Total fresh air
13.Cleaning and disinfection before each filling operation
14.Blood agar plate exposure and air sampling by millipore filter technique
15.Machine lubricants used are checked for sterility
2. Filling

1. Bacterial filter are bubble tested before and after use


2. Measurement of current volume or weight from each filling head
periodically
3. Identification of line and equipment
4. Evaluation of containers by clarity test
5. Filling hood disinfection and tagged for the product
6. Aseptic filling monitoring by exposure of blood agar plate
7. Filling area and filling station for air velocity
8. Vials and ampoules a control and lot no.
9. Vial washing check for cleanliness of water, air, steam and washer
10.Rubber stopper and cap washing and steam sterilisation
3. Sterilisation
a. Steam:
1. Record with time, date, product, batch and chamber number
2. Temp, recording with date including time and temperature of
the product being sterilised .
3. Weakly intervals sportex test and strip exposure for validation
4. At longer intervals bottles with thermocouples for uniformity
of heat.
b. Filtration
5. Type and porosity of filters
6. Integrity results before and after
7. Sterilisation record
8. If filter changes should be recorded
4. Leak Test

By vacuum with immersion in a coloured water

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

1. Higher percentage of rejection in vial due to white


particles
2. Material problem- variation in wetting while
manufacturing ethambutol HCL from batch to
batch
3. Man and packing material problem- detection of
source of insects in PP aluminium caps due to IPQC
4. Machine problem
5. Man and method problem- a multi ingredient
sugar coated tablets showed excessive cracking
after polishing stage.

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