Process control testing

Manufacturing validation data, which should aim to identify the critical process steps, especially for nonstandard manufacturing processes such as for new dosage forms, should be discussed in the development pharmaceutics section of the application. Validation data may be accepted based on closely related products. In-process control tests and acceptance limits should be included for any aspect where conformity with the finished product tests cannot otherwise be guaranteed (e.g., mixing, granulation, emulsification and nonpharmacopeial sterilization processes). 

Quality of conformance (how well the product conforms to the specifications required) is influenced by a number of factors, including the choice of manufacturing processes, the training and supervision of the workforce, the types of process controls, tests, and inspection activities that are employed, the extent to which these procedures are followed, and the motivation of the workforce to achieve quality. 

In-process control testing that occurs during manufacture ... 

Manufacturing procedure Outline of manufacturing and packaging Copy of the master formula and a copy of a manufacturing record Details of sterilization Stages of sampling and in-process control tests ... 

A representative sample should be taken for the purpose of performing a retest. The company s overall policy, intentions, and approach to validation, including the validation of production processes, cleaning procedures, analytical methods, in-process control test procedures, computerized systems, and persons responsible for design, review, approval, and documentation of each validation phase, should be documented. The critical parameters/attributes should normally be identified during the development stage or from historical data, and the necessary ranges for the reproducible operation should be defined. This should include ... 

Is the staff deficient in the application of their knowledge of sewage treatment and interpretation of process control testing such that improper process control adjustments are made ... 

Disintegration testing is an important part of in-process control testing during production to ensure batch-to-batch uniformity, but its role in end-product testing has largely been superseded by dissolution testing. 

Process control implies measurement of critical parameters of raw materials and intermediates as they are converted to finished products, and monitoring and controlling the critical process parameters that may influence finished product quality. Process control is what parametric release is all about. In processes where the level of reliability in process control can be predicted to be high, there is a sound basis for eliminating the sterility test. Where process control is not so reliable, the sterility test should be considered as one part of the armory of process control, tests rather than as an overriding end-product test, in other words a Pass in the sterility test should never in these processes be allowed to overrule evident failure to meet all of the prescribed in-process test criteria. 

IN-PROCESS CONTROL Tests, checks and measurements made during the course of manufacture (including packaging) to ensure that the resultant product will comply with its specification and to provide feedback to production for process adjustment The control of the environment or equipment may also be regarded as a part of in-process control. In-process control may be a responsibility of either production or quality control. 

Validation of the process can, however, be partly based on the processing and evaluation of in-process data provided it is evident that the reliability of the process can be unequivocally and accurately judged in terms of the results from these in-process control tests and final end product... 

IN-PROCESS CONTROLS Testing and activities performed during production to monitor and, if necessary, adjust the process. 

Specific production instructions in the correct sequence with all necessary control parameters, time limits, yield ranges and in-process control testing and specifications. 

A. Preparation for Analysis HPLC METHOD DEVELOPMENT IN-PROCESS CONTROL TESTS... 

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