1. In-process quality control (IPQC) involves monitoring and adjusting manufacturing processes to ensure products meet specifications from raw materials to finished products. 2. IPQC includes tests and inspections of materials, equipment, processes, and operations during production to check for accuracy, uniformity, and consistency within and between batches. 3. Common in-process controls for pharmaceuticals involve testing attributes like weight, content of active ingredients, disintegration, and checking for contamination.

1. IN PROCESS QUALITY
CONTROL TEST
$ ICH GUIDELINE
Guided by:-
presented By:-
Mr. Govind Bhandari Sir Anil Kumar

2.  IPQC IS
CONCERNED WITH PROVIDING ACURATE ,
SPECIFIC AND DEFINITE DESCRIPTION OF
PROCEDURE TO BE EMPLOYED FROM THE
RERCEIPT OF RAW MATERIAL TO THE RELEASE
OF THE FINISHED PRODUCT.

3. IPQC: Definition:-
 Checks performed during production in order to
monitor and, if necessary, to adjust the process to
ensure that the product conforms to its
specifications. The control of the environment or
equipment may also be regarded as a part of
inprocess control.
 In-process controls are usually performed within
the production area. The performance of such in-
process controls should not have any negative
effect on the quality of the product or another
product.

4. IPQC:-
 In-process inspection and testing should be
performed by monitoring the process or by actual
sample analysis at defined locations and times.
 Work instructions should delineate the procedure
to follow and how to use the inspection and test
data to control the process.

5. Introduction:-
 IPQC is concerned with providing accurate, specific,
and definite description of procedures to be
employed from the receipt of raw materials to the
release of finished dosage forms.
 It is a planned system to identify the materials,
equipment, process, and operations.
 In general the in process control procedures are
usually rapid and simple tests or inspections that
are performed when the manufacturing of a
product batch is in progress.

6.  It is an imp function of IPQA programme to ensure that
the finished dosage forms have uniformity, purity, and
quality within batch and between batch.
 Is accomplished by identifying critical steps in
manufacturing and controlling them within defined
limits.

7.  IPQC aims to increase the assurance of batch
uniformity.
 There must be written procedure describing the
control and test or examination to be conducted.
 In process specification/controls must be rational
and consistence with the finished product
specification.
 They derived from previous validated process
variations.

8. 1. UNIFORMITY OF CONTAINER CONTENT .
2. CONTENT OF ACTIVE INGREDIENTS .
3. UNIFORMITY OF CONTENT
.
4. FRIABILITY .
5. DISINTEGRATION .
6. TABLET THICKNESS.

9. 1. loss on drying on capsules blend .
2. Disintegration test of capsules during filling .
3. Weight variation during filling of capsules .
4. During packaging strips sealing test (leak test).

10. PRODUCTION ACTIVITY machine
-machine calibration
1 LEAN MANUFACTURER - machine qualification
2 SIX SIGMA - process parameter logging
IN PROCESS
PRE PROCESS
-PROCESS QUALIFICATION -
-material certification
Operator
-operator training
- operator qualification

11. 1. WEIGHT AND VALUME MEASUREMENT .
2. POTENCY ASSAYS .
3. OINTMENT SAMPLING FROM DIFFERENT CORNER FOR
UNIFORMITY .
4. SUSPENSION UNIFORMITY AT THE TIME OF PACKAGING .
5. SPECIFIC GRAVITY FOR SOLUTION ,SUSPENSION ,AND
EMULSIONS.
6. VISCOSITY FOR FLUIDS ,OINTMENT ,CREAM ,AND JELLIES.
7. SEDIMENTATION VALUME BY CENTRIFUGE AS RAPID METHOD.

12. The in process controls depend on the complexity of the product.
The production line for parenteral manufacturing consists of the
Following steps –
1. Material ,equipment ,area .
2 Sterilazation
3 Filling
4 Leak testing
5 Checking

13.  THESE TEST ARE QUALITATIVE CHEMICAL METHOD USED TO CONFIRM THE
ACTUAL PRESENCE OF COMPOUND .
 FOR EXAMPLE == COLOUR FORMATION ,PRECIPITATION ,DECOMPOSITION
,INFRARED SPECTRA ,ULTRAVIOLET ,VISIBLE SPECTRA ,CATION ,OR ANION
DETERMINATION TEST.

14.  THESE TEST ARE THE PHYSICAL METHOD USED TO MEASURE ACCURACY
THE CHARACTERISTIC PROPERTIES OF DRUG .
 FOR EXAMPLE

15.  In process controls for physical operation may
includes the following:
 Appearance and color.
 Uniformity of the blend.
 Temperature of a process.
 Concentration of a solution.
 Processing rate or time.
 Particle size analysis.
 bulk / tap density.
 pH determination.
 Moisture content.

16. International confrence on harmonization
Q1A –Q1F – STABILITY TEST
Q2 - ANALYTICAL VALIDATION
Q3A –Q3D -IMPURITIES TEST
Q4 –Q4B –PHARMACOPOEIAS
Q5A - Q5E – QUALITY OF BIOTECH. PRODUCT
Q6A –Q6B – SPECIFICATION
Q7 A– GOOD MANUFACTURING PR

17. Q8 – PHARMACEUTICAL PRODUCT
DEVOLOPMENT
Q9 – QUALITY RISK MANAGEMENT
Q10 – PHARMACEUTICAL QUALITY SYSTEM
Q11 – DEVOLOPMENT $ MANUFACTURING OF
DRUG SUBSTANCE
(QUALITY, EFFICACY ,SAFETY,MULTIDISCIPLINARY)
ICH WORKING GROUP
ESTABLISHED IN 1990