Regulatory inspectors

Authorized or regulatory inspectors, who operate within a specific jurisdiction and have legal or similar powers to prohibit the use of the equipment or direct repairs where deemed necessary. 

Unless a product is clearly marked, it is sometimes impossible for regulatory inspectors to distinguish between professional and consumer use [477]. 

Two experienced regulatory inspectors, Ronald Tetzlaff and Anthony Trill, have published papers describing inspection practices for computer systems adopted by the FDA and MCA (later MHRA), respectively." " These papers present a comprehensive perspective on the current validation expectations of the regulatory authorities. Topics covered included the following ... 

The concept of a Validation Summary Report can be taken a step further in the form of a Validation Certificate. This merely states that a computer system is validated, and it specifies a review date against this validated status. While a Validation Certificate could be presented to a regulatory inspector as evidence of validation, this would probably just prompt the inspector to request more detailed information. The effort to produce and maintain Validation Certificates must be carefully weighed. 

Company personnel need to perform well during the inspection. Presenters and supporters need to be alert and ready throughout. The inspection is not over until the regulatory inspector is traveling back home. 

LIMS must be backed up on a regular basis to maintain the security of the database. The regulatory inspectors will not accept that data within the database has been lost due to the failure of the server or other incidents (e.g., fire or flood). In order to prevent losses the pharmaceutical manufacturer is responsible for implementing a reliable, robust, and documented backup regime. The frequency of backups must be assessed as part of the GxP assessment process as this will be determined by the frequency at which data will be entered into the database and the redundancy features in the server, and should take into account the risks of data loss. Automation of the backup regime is acceptable provided that it is validated normally as part of the operational testing phase of the project. 

In order to gain experience in the process outlined in HSG 254 it was agreed that a Hull site plant would be used in the pilot. A review session was planned with operational and technical representatives from the plant together with the local Health Safety Executive Regulatory Inspectors and the author of HSG 254 who lead the review process. 

The calibration and validation of equipment have been addressed extensively but, equipment that can be shown as fit for use, within the GLP environment is generally acceptable to most regulatory inspectors. (For additional information on the GLP requirements for equipment, see Principles, Section II, 4, p. 22.)... 

While validation is the final company challenge of the design capability, validation documentation is often the first point of challenge by regulatory inspectors, looking for proof that quality requirements have been built into the design and process. 

From the inspectorates viewpoint, however, quality documentation is critical for all the key stages before and during manufacture. In the event of complaints or referrals from the market or regulatory inspectorates, it is archived batch and test documentation that must provide traceability to the quality conformance history of ... 

An additional problem that is not unique to the UK may be that regulatory inspectors themselves do not have the necessary expertise to feel sufficiently confident to require monitoring and control measures involving the understanding and use of OELs from en jloyers. This may be a factor in the low level of enforcement involving the use of OELs, which in turn fails to provide the incentives to employers to seek sufficient access to expertise to enable the conq)etent use of OELs in monitoring and control of chemical hazards. 

The Labour Inspectorate has the normal range of powers found in most European regulatory inspectorates. Inspectors may use ... 

The regulatory body shall be given adequate powers and authority to enforce comphance with its requirements and hcence conditions, and should have available a number of methods of enforcement to provide the flexibility to use the method best suited to the seriousness of the violation and the urgency of corrective actions. The degree of authority of the regulatory inspectors should be clearly specified and clear administrative procedures should be adopted and implemented. 

The main advantage of announced inspections is that the regulatory inspector is able to discuss plans and needs with the operator s personnel in advance in order to secure assurances that documentation will be available for inspection, personnel will be available for interview and activities can be inspected as scheduled. Hence, the announcement of inspections may enhance their effectiveness. The advantage of unannounced inspections is that the actual state of the facility and the way in which it is being operated can be observed. Inspections may be carried out at any time of the day or night so as to provide a more complete picture of the situation at the facility. 

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