Validation maintenance

Supplementing a validation maintenance program (also called continuous validation life cycle) that includes a mechanism to control changes to the system and establishes and carries out scheduled preventive maintenance, including recalibration of instruments. 

Sites must operate a validation maintenance regime incorporating change control and re validation programs. 

Beyond the periodic evaluation of the product, process, or system it is important to assess that the other elements that contribute to the validated state are still in place. This would include an assessment of change controls, calibration, product annual reports (if applicable), process deviations (waivers, alerts, etc.), physical inspection of the equipment, and an evaluation of relevant regulatory guidance. All of these help to augment the data generated in the revalidation study and significantly support the dossier proving successful validation maintenance. 

Ongoing monitoring, change management, calibration, and preventive maintenance are essential components of validation maintenance. 

VMP for its successful execution. Reference the location of each deliverable and provide the detail necessary for retrieval at a later date (e.g., SOP and protocol numbers). Identify any conditions surrounding the use of the system. Were some features of the system found to be unsatisfactory for use Clearly state what aspects of the CRS are not approved for use until they are re-engineered and tested and what formal controls are in place to enforce this (SOPs, security programming, etc.). Design the VMP so that approval of the MVS document is the end point that releases the CRS for GMP use by appropriately trained users. This end point is called system acceptance and signals the transition to the validation maintenance phase of the system life cycle. 

Validation of cleaning Monitoring of cleaning Validation maintenance Revalidation (when appropriate)... 

Monitoring is an essential and vital component of cleaning validation and validation maintenance. 

The success of validation maintenance is contingent upon a comprehensive and far-reaching change management system. 

Validation Maintenance — Operational Ongoing support and integrity checks... 

Training operators in the cleaning SQP is an important part of validation maintenance, particularly for manual cleaning methods. Training in a manual method should include a classroom discussion of the method, observation of the SOP being performed by a trained operator, and then demonstration of proficiency by performance of the SQP by the trainee. Training should always follow revision of the SQP, and retraining... 

Thus, if quality is established in terms of precision and reproducibility of the results obtained in the studies (i.e. in the respective sets of measurements or experiments), the need to provide for each of the studies a study plan, approved by the head of the laboratory before the experiments or measurements can be started, will not be an important consideration. Certainly, Standard Operating Procedures will have to be observed, and the acknowledged methods will have to be followed, with any deviations to be described and justified. Since it is the quality of the result which counts for the determination of the test facility s quality , and not the way on which it has been obtained, there is no need for a single point of study control in the person of the Study Director. Certainly, a laboratory head will have to be appointed, who has to ensure that the quality of the data obtained in the laboratory remains high, and who has to provide the necessary education and training for the technical personnel in order to enhance and update their technical expertise. If precision and reproducibility are the primary purpose of the test facility s quality concerns, then apparatus, instruments, equipment and computerised systems have to comply to the highest technical standards in terms of validation, maintenance and calibration. 

The purpose of validation is to obtain written evidence that processes and equipment work within their specifications to produce products of the demanded quality. However, when working with processes and equipment, there are always risks that may or may not be acceptable. To prove whether or not possible risks are acceptable for the product quality, a risk analysis (RA) must be done. The purpose of the RA is to identify critical and noncritical parts of processes and equipment. This risk analysis also identifies the activities necessary for validation, maintenance, and calibration. 

Thereafter, the new autoclave must be validated and scheduled for routine re validation, maintenance, and recalibration at appropriate intervals. Since the... 

Validation maintenance, an ongoing activity for manufacturing processes [11], continues through the life cycle of the process with a changing focus as the process matures [20]. There is a need to address the process life cycle as a whole and not to suspend process validation after three production scale runs are completed [14]. To support this life-cycle approach, process expert teams are created to rapidly resolve process deviations, determine trends toward loss of control, comply with regulatory requirements, assess process change impact, and identify areas for process improvement [11]. 

When this definition of fitness for purpose is applied to toe pharmaceutical industry, it can be seen to fit well with toe concepts of quality. Personnel have to be shown to be fit for purpose for toe job they are employed to do (training, education and experience). Equipment needs to be demonstrated as fit for purpose based on qualification/validation, maintenance and calibration. Manufacturing processes are deemed fit for purpose based on in-process testing, process validation, etc. Process materials are shown to be fit for purpose based on testing appropriate to their intended use in toe process. This use will vary depending on toe stage of processing and whether it is a primary (chemical) process or a secondary (formulation) process. 

A validation master plan that contains concepts of qualification, requalification, risk assessment, validation, maintenance, periodic inspections, and system retirement is kept. 

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