Validation of Support Processes

Validation of Support Processes Test Functions and Acceptance Criteria... 

Validation of support processes. Define test functions and acceptance criteria for critical validation support processes such as washing of components, sterilization of components, depyrogenation, etc. 

Validation of support processes test functions and acceptance criteria... 

Process validation Inspection of the establishment to determine compliance with cGMP requirements and adherence to application requirements is a Field responsibility. CDER may request data to support validation of sterile processing operations for example, environmental monitoring, equipment validation, sterile fill validation, and associated sterile operations. 

The developmental documentation to support the validation of the process may contain the following ... 

In 1980, the European Organization for Quality Control (EOQC as it was called then, now only EOQ) devoted its seminar in Geneva to validation of manufacturing processes. The discussions were conducted by three working groups general considerations, administration, and control, equipment and support systems, and standard operations. The results of these discussions were summarized in the following commonly accepted conclusions [5] ... 

The preparation of sterile materials requires execution of a number of supportive processes that together constitute the manufacturing process. They are intended to control bioburden, reduce particle levels, remove contaminants, sterilize, and/or depyrogenate. Nearly all of these activities occur within the controlled environments and are subject to qualification/validation. 

Quality assurance must approve each batch to be marketed by the unit, manufactured by the unit for use in clinical trials, submitted to regulatory agencies in support of registrations, or used to support validation of a process. 

In the area of pharmaceutical industries in most countries, validation of manufacturing processes and supporting functions is the fundamental issue for the quality assurance of products. Analytical methods and procedures are associated with most evaluation activities in this field. Analytical validation is an essential prerequisite for any evaluation work during process validation,... 

The validation of any process or product relies upon several supportive activities. Validation in the absence of these activities has only minimal utility, as it is only through the integration of these other practices that meaningful validation can be accomplished. Several of these activities are defined in CGMP regulations while others are an integral part of a company s organization structure or are closely associated with validation itself (11). 

Vendor support to validation—A common practice in BPC production is the subcontracting of certain chemical steps to outside suppliers. As is the case with subcontracted production for dosage forms, the owner of the NDA or DMF maintains responsibility for the validation of the process and must secure the cooperation of the subcontractor in the performance of any supportive qualification/validation activities. Agreement to this arrangement should be a precondition to the awarding of the contract to the supplier. 

As understood and interpreted by the pharmaceutical industry, validation is concerned with gaining assurance that the software will do what it purports to do, and will not do what it purports not to do. The term validation is usually used to mean the practical activities aimed at ensuring this state of affairs. These activities are essentially systematic structural and functional testing, supplemented and buttressed by the acquisition of supporting process documentation. 

GLP regulations require QA personnel to inspect/audit each study conducted, but the extent to which QA personnel are involved in software development and the val-idation/verification process varies from company to company. In some companies, there is little or no QA involvement in these processes, whereas in others QA personnel are involved. QA personnel can provide assistance in the area of vendor audits for purchased software or can conduct inspections of in-house software development to ensure that internal procedures are being followed. QA personnel, who conduct in-process inspections and review the resulting data and validation report for accuracy, could provide inspection support during the validation and verification process. During system development and validation, properly trained QA personnel can provide the regulatory advice needed to ensure that the system will meet government standards. QA personnel become more familiar with the system(s) that will be used when they are involved early in the validation process. 

The laboratory ensures that the processes that are used for the performance of the analysis operate within defined limits and that the equipment used for the performance of such processes are approved and the persoimel using this equipment are qualified. The operation of the laboratory activity is based on the use of specific methods and procedures. Objective evidence that the whole laboratory activity is under control is supported by the relevant records that the laboratory keeps and manages. Processes shall be re-validated from time to time as well as after the occiurence of any changes that might affect the process. 

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