IN PROCESS QUALITY CONTROL TEST

$ ICH GUIDELINE

Guided by:- presented By:-

Mr. Govind Bhandari Sir Anil Kumar Chouhan

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.

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.

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.

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.

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.

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.

1. UNIFORMITY OF CONTAINER CONTENT . 2. CONTENT OF ACTIVE INGREDIENTS .

3. UNIFORMITY OF CONTENT . 4. FRIABILITY .

5. DISINTEGRATION .

6. TABLET THICKNESS.

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).

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

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.

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

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.

THESE TEST ARE THE PHYSICAL METHOD USED TO MEASURE ACCURACY THE CHARACTERISTIC PROPERTIES OF DRUG .

FOR EXAMPLE

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.

International confrence on harmonization Q1A –Q1F – STABILITY TESTQ2 - ANALYTICAL VALIDATION Q3A –Q3D -IMPURITIES TESTQ4 –Q4B –PHARMACOPOEIASQ5A - Q5E – QUALITY OF BIOTECH. PRODUCTQ6A –Q6B – SPECIFICATION Q7 A– GOOD MANUFACTURING PR

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