Ipqc

In process quality control

1. IN-PROCESS QUALITY CONTROL Student name: Ms. Bhalekar Pournima Ashok ( Pharmaceutical chemistry, Roll no- CH101) Guide name: Mrs. M. Harde (Ass. Prof. Pharmaceutical Analysis)

2. IPQC: Definition IPQC Concerned with providing accurate specific and definite description of procedure to be employed from the receipt of raw material to the release of the finished product . 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 in process control.

3. 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. 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.

5. Objective To minimize the human errors. Provides accurate, specific, and definite description of the procedure to be employed. To detect the errors if and when it does occur. Corrective action instituted by people. To pin point the responsibility to the personnel involved in the operation of the entire process. To enforce the flow of manufacturing and packing operations according to established routes and practice. Rigidly followed. Should detect any abnormality immediately and at the same time indicate the kind of action needed to correct the problem.

6. Example : IPQC OF TABLET Uniformity of container content. Content of active ingredient . Uniformity of content. Friability. Disintegration. Tablet thickness. Hardness

7. Tablet hardness testing, is a laboratory technique used by the pharmaceutical industry to test the breaking point and structural integrity of a tablet "under conditions of storage, transportation, and handling before usage. The breaking point of a tablet is based on its shape. It is similar to friability testing, but they are not the same thing. Hardness testing

8. Friability: It is the tendency of tablets to powder, chip, or fragment and this can affect the Elegance appearance , consumer acceptance of tablet, and also add to tablets weight variation or content uniformity problems. It is property that is related to the hardness of the tablet. Commonly used friabilator in industries is Roche Friabilator