Change control systems

There is general advice that the manufacturing process should be described but not so comprehensively as to necessitate frequent variation application for relatively minor changes. The details submitted in the application are binding and will need formal approval before they can be changed. Manufacturers are expected to have an appropriate change control system to ensure that this is undertaken appropriately. 

The roles and responsibilities of the transfer lab and the receiving lab as well as an outline describing deliverables and timelines should be defined clearly at the initiation of the assay transfer process. Once a transfer protocol is defined, any deviation from the protocol during execution should be discussed in the transfer report. Explanations as to why the deviation is acceptable should be included in the report. The transfer report should also be approved by relevant functional departments. Due to the complexity of multi-site involvement, having a good change control system in place is important for making SOP modifications or updates. 

Conhrmation that change control systems have operated effectively... 

It should also ensure that change control systems are in operation, and that all systems have been verified to operate under no load conditions. 

Ensure that change control systems are in operation... 

Failing to have a formal process change control system in place. 

Often, the best examples of process efficiency can be found outside the pharmaceutical and biopharmaceutical industries. Other fields such as electronics, space, and software industries have evolved their documentation, training, quality, and change control systems to the point of best in class. These industries are more time sensitive to get product to market and have often evolved their processes to be efficient and decision processes to be very quick. Process owners may expand their knowledge by investigating other industries to find best practices and apply them internally. 

Change Control System configuration changes hardware, firmware, and software change and its impacts. 

This section makes a statement about the revalidation activities for the process and also states that any changes will be captured under the existing (validation) change control system. 

The implementation of a change control system is an important and necessary step in the validation approach for equipment and facilities. Vital to any change control system is its efficiency in that it does not require too much time and effort to handle changes. In order to design an efficient change control system, the following aspects need to be taken into consideration ... 

A change control system should require input where appropriate from the original research and design groups to assure that all possible aspects and potential impact are fully reviewed. 

Most firms today use a validation change control system, by which such documents as engineering work orders, revisions to standard operating procedures (SOPs), and proposed formulation order changes are reviewed by a committee of the same disciplines as those responsible for validation approvals. The objectives are to determine the potential impact on validation status before formally approving the change. This mechanism enables a firm to take immediate prospective action, obviating the need to revalidate the entire system. 

A stringent change control system must be developed and implemented to provide a complete history of the analytical method and validation protocol. This system must fully document each of the changes made to a method and whether or not the change affects previous validation results. Often the... 

An effective change control system must allow a firm to proactively evaluate proposed changes to a method before they are implemented. 

The firm should have a well-defined change control system that clearly defines change criteria for methods that require revalidation. In this instance, the change control system would have required a revalidation and an update to the original validation report. 

Many organization take a change control committee approach however, a comprehensive change control system based on a key change control form or cover sheet and related documentation may prove more efficient. 

Describe or reference the change control system that will be used to maintain the validated state of the VUS after the initial qualification. 

Annual product reviews should be facilitated by the change management system. The change control system will allow for capturing specific aspects of a particular given time period. 

Computer validation should not be undertaken unless fundamental validation controls have been fully understood and implemented within the pharmaceutical or healthcare company s organization. Here we allude to properly qualified personnel, effective document management and change control systems, internal audit procedures, methods of managing the deviations from standard practice thereby exposed, and a culture of continuous improvement (see Chapter 4 for more details). Senior management must not fall into the trap of assuming through complacency or idleness that these controls have been fully instituted In most firms there is usually much that still needs to be done in these areas. Let us examine these controls a little more closely. 

Is there more than one change control system (hardware, software, infrastructure, networks) For each of these challenge as follows ... 

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