Validation change control

To describe the procedure to prevent uncontrolled changes in validated equipment and processes 

All concerned departmental managers are responsible for following the procedures. The quality assurance manager is responsible for SOP compliance. 

Change Any subsequent departure from the approved flow chart 

Change control A formal monitoring system by which qualified representatives of the appropriate discipline review actual changes that might affect a validated status to determine the need for corrective action ensure that the system retains its validated state. 

The departmental manager will initiate a process change request form prior to any change in the approved and authorized procedure. The form will be forwarded to the quality assurance manager to review and approve. 

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As far as possible, systems existing in a production mode prior to the effective date of the GALP standards, as well as purchased systems, should be docmnented in the same way as systems developed in accordance with the EPA System Design and Development Guidance and Section 7.9.2 of the GALPs. Documentation relevant to certain phases of the system fife cycle, such as validation, change control, acceptance testing, and maintenance, should be similar for all systems. 

Establishing documented evidence that a system does what it purports to do. Validation Change Control... 

The basic structure of the ICH GMP guideline for API production is shown in Table 15. It consists of 19 chapters, which cover the requirements for quahty management, personnel, premises, equipment, documentation, materials, production and process controls, packaging and labeling, storage and distribution, laboratory controls, validation, change control, complaints, recalls, contract services, cooperators, APIs manufactured by cell culture/fermentation, and APIs used in clinical trials [52]. 

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. 

Figure 20 Validation and validation change control decision tree.

Figure 21 Example of validation change control form.

Change control Complaints and recalls Contract manufacturers and laboratories Agents, distributors, repackers, and relabelers Specific guidance for API manufacture by cell culture or fermentation APIs for use in clinical trials (quality, equipment, facilities, control of raw materials, production, validation, change control, laboratory controls, and documentation)... 

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. 

These documents were all designed to support an audit of the system to answer questions about design, installation, initial operation, validation, and continued operations of a water system. However, since that time better and more appropriate methods have been made available to accomplish the same tasks, but in a more efficient manner. Cohen illustrates the use of electronic documentation approaches for accomplishing the same validation tasks, but in real-time. The improper use of the term revalidation limited the use of these real-time approaches, when in fact, as Cohen points out, what was intended was change control. In reality, what was meant to be accomplished was not revalidafion of the water system, but validating change controls. ... 

Furthermore, they implemented change control requirements that fulfill Cohen s observation for validating change control and not a revalidation of the total system. 

This system assures overall compliance with cGMPs and internal procedures and specifications. The system includes the quality control unit and all of its review and approval duties (e.g. change control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.). It includes all product defect evaluations and evaluation of returned and salvaged drug products. 

The software life cycle activities extend until retirement of the software. However, in a manner of speaking, life cycle activities extend even beyond retirement since the data must be able to be reconstructed at any time during the life of the product, i.e., the archived record must always be accessible and readable even if the software is no longer commercially available or typically employed in the laboratory. Additional software validation includes implementation of the code and integration and performance testing. There also must be system security, change control procedures, audit trails, calibration, preventative maintenance, and quality assurance. 

The validation umbrella not only covers in-house systems, but also covers vendor systems. Much of industry today is dependent to some extent on vendor-supplied electronic systems and, consequently, the vendor s validation of those systems. Because of this, there are validation issues to assess at the vendor including how the vendor addresses change control, testing and documentation, source code, integration, and implementation of the system during development. Implementation support also must be assessed. 

CFR - Part 11 means that you must be qualified to do your work, your programming must be validated, you must have system security in place, and you must have change control procedures for your SAS programming. The current additional FDA guidance on 21 CFR - Part 11 is titled Guidance for Industry Part 11, Electronic Records Electronic Signatures—Scope and Application. ... 

Approaches to Process Validation Process Validation Program Periodic Review of Validated Systems Cleaning Validation Validation of Analytical methods Change Control, Rejection, and Reuse of Materials Rejection Reprocessing Reworking... 

The change control SOP warrants particular attention. This procedure should clearly spell out how any deviations in instrument operation/per-formance, and hardware/firmware/software updates are to be handled and documented. It should also make clear what distinguishes routine maintenance, minor vs. major changes and what the procedural differences should be. The change control procedure may be a specific SOP, as part of an HPLC system s validation plan, or as part of the corporate validation master plan (VMP) that is established within each company. 

This is a list, by title and location, of all internal and manufacturers SOPs pertaining to the instrument being validated. This should also include any change control procedures. 

Production engineer Process observations and geology Manufacturing scheduling Coordinates development within production Validation and change control management Operations... 

Validation, operation, maintenance, security, change control, back-ip... 

Change control is a formal monitoring system by which concerned representatives of appropriate departments review proposed or actual changes that might affect the validated status and cause corrective action to be taken that will assure the system retains its validated state of control. 

Criteria Periodic Revalidation When there is no significant change to affect the validation status as governed by change control... 

Frequency Promptly to preserve validation status. Monitoring through change control procedure... 

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