OPERATIONS MANAGEMENT

In Process Control

Achu James P11104 PGDM A

In-process controls (IPC) are checks that are carried out before the manufacturing
process is completed. The function of in-process controls is monitoring and if necessary adaptation of the manufacturing process in order to comply with the specifications. This may include control of equipment and environment, too. In-process materials should be tested for identity, strength, quality and purity as appropriate and approved or rejected by the Quality Control unit during the production process. Rejected in-process materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturing. Written procedures should be established and followed that describe the In-process controls and tests as specified: Tablet or capsule weight variation, Disintegration time, Content uniformity and homogeneity, Dissolution time and rate, Clarity, completeness or pH of solutions. In-process controls may be performed in regular intervals during a process step or at the end of a process step (e.g. granulation, blending). The objectives of in-process control are both quality control and process control. So, in a simple sentence we can say that a in process control is a process controls that checks the process are carried out before the manufacturing process is completed. This is done because to ensure that defective output do not leave the process and will not a part of the process. Major function is to monitor the production process that are carried out in a production process.This can be say like the adaptation of the manufacturing process in order to comply with the specifications. In process quality control system is needed to ensure that defective output do not leave the process and , more importantly to prevent them in the first place. In designing in process control system three key issues should be considered. What to control, where to control and how much data to gather. Many organization fall into the trap of trying to control every possible product or process characteristics. This can be a wasteful of time practise. Instead the experts suggest that it should be measured and controlled closely related to the cost or key customer requirements, easy to gather and should provide useful information to help the organization to improve. The decision of where to control is fundamentally an economic one. An organization must consider trade off between the explicit cost of detection, repair or replacement and the implicit cost of allowing a non conformity to continue through the production process. The final issue is to gather the data. The data can be gather in two ways by selecting a sample and take the needed information or from the complete inspection of the product. Samples can be differentiated according to their representativeness. Non-representative random samples that intentionally provide a snap-shot of the manufacturing process are used for the purposes of process control. Samples that are generated for the final control are designed as representative samples. Unless a manufactured goods requires a

destructive testing in which case sampling is necessary or faces critical safety concerns in which case complete inspection is warranted or regulated under the law, the best choice can be addressed economically . In fact on a strict basis the choice is to have either no inspection or complete inspection. The principle of this control function is shown in figure

During manufacturing and packaging a lot of data are recorded which represent control factors of the manufacturing process. These data may be process parameters (e.g. outlet air temperature of a fluid bed dryer) or product attributes (e.g. hardness of tablet cores). The results of the measurements may indicate that a corrective action is required to maintain the process and the product within the specified ranges. The limits within which modifications may be carried out to match measured values must be determined in advance. The drying of a granulate is described here as an example. The objective, i.e. the resultant granulate humidity, is determined within the scope of the manufacturing instructions. If the specified range has not yet been achieved, the normal course of action is to extend the drying time. In this case, it is irrelevant whether the control is automatic, e.g. by means of online measurement within a fluid bed dryer or manual sampling. Organisation and responsibilities All the in-process controls, including those made in the production area by production personnel, should be performed according to methods approved by Quality Control and the results recorded. Precise information about the area of responsibility to which the

accomplishment of in-process controls is to be assigned cannot be found in the Guide. There is merely the requirement that the procedures have to be authorized by quality control.

The responsibilities and tasks for the in-process control must be clearly laid down in organisational instructions. A number of aspects has to be considered. When deviations occur, or where release analyses of intermediates are carried out outside of production, a method must be defined that prevents continued processing of the material until the decision or the result is available. Material may be rejected by means of operating data management whereby the process chain is interrupted. Physical designation of the product affected by means of labelling is recommended.