Good Manufacturing Practice validation procedures

Quality system regulation The past good manufacturing practice (GMP) and process validation (PV) was renamed to quality system regulation (QSR). It is important for the medical device industry (that uses an extensive amount of plastics) and also in other product industries where they want to follow strict processing procedures. It sets up an important procedure for many plastic fabricators to consider that targets to ensure meeting zero defects. 

Since the U.S. vs. Barr decision in 1993 (relevant to pharmaceuticals and related fields, rules applied by the Federal Food Drug Administration, FDA), outlier tests may no longer be applied to physicochemical tests, under the assumption that such test methods, having been optimized and validated for the particular set of circumstances, rarely produce outliers. These tests may not be applied to CU results at all. Good manufacturing practices mandate that operators work according to pre-set procedures and write down any observed irregularities as they... 

A quality assurance system usually involves a matrix of written procedures. Good manufacturing practices (GMPs) are thus frequently equated with quality assurance systems. By similar lines of reasoning, validation, quality assurance, and GMPs are often associated with each other and even occasionally treated synonymously. 

Validation Action of proving, in accordance with the principles of Good Manufacturing Practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected results (see also qualification) (EU PIC/S). 

Software and computer systems used in analytical laboratories that must comply with good laboratory practice (GLP) and good manufacturing practice (GMP) regulations require formal validation to confirm that they meet the criteria for intended use. Both new and existing systems, regardless of age, must be validated for their suitability for indented use. Whereas the first three articles in this series [1-3] focused on validation during development, vendor qualification, and installation and operational qualification of new systems, this article describes the procedures for systems that have been purchased, installed, and used prior to formal validation and that must be newly documented. 

Analytical method transfer should be performed using a validated procedure this transfer data can be useful in determining intermediate precision of the method. The transferring laboratory should ensure that the recipient laboratory(s) is (are) current Good Manufacturing Practice (cGMP) compliant a record of successful audit by QA personnel is essential, especially if the laboratory is a contractor. 

Validation and process analytical technology (PAT) require that we find and control the primary sources of product and process variation. Not many people realize that the current good manufacturing practice contain the words validation and variability in the same sentence. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (1). 

Validation studies should reinforce Good Manufacturing Practice and be conducted in accordance with defined procedures. Results and conclusions should be recorded. 

Validation is a once-off procedure that should only be repeated if major changes to equipment or processes have taken place. The objective is to establish a valid process. In-process control and validation co-exist in Good Manufacturing Practice or Quality Assurance systems, in-process data can be used (after processing of the data) during the validation study, or it may form the basis of a retrospective validation exercise. (See below). Thus, the results of in-process controls can be used to provide some of the evidence required for validation but are no substitute for validation. 

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