Dental Validation requires that all dental practices, workshops and manufacturers are compliant with the sections in 21 CFR Part 820 applicable to their activities. A trawl through current FDA Warning Letters however shows wide spread transgressions; many quite petty and simple to negate, others rather more serious and requiring a speedy in depth response.
It is imperative that companies which are in default respond to a regulatory default as soon as possible. Often it is not possible to immediately rectify all aspects of the default(s) – but it should be possible to design a concise defined remedial plan of action and present it to your regulators. After that it is paramount that the remedial plan; time lines and key-point dates are achieved and progress published. Such actions will give your auditors confidence that they can work with you rather than having to resort to citations.
Validation Online have produced a full complement of validation documents for dental facilities to use. Starting with the Validation Master Plan (VMP) continuing through the Validation Plan (VP) and on through the User Requirements Specification (URS) to the Validation Risk Assessment (VRA) and ending with the Design Qualification (DQ).
For the Installation, Operational and Performance Qualification protocols, we have opted to use a single combined IQ/OQ/PQ protocol. This document can easily be edited up or down in size and can be copied over as many times as is required.
This will be the individual with ultimate responsibility for decontamination equipment ownership and the definition and appointment of the following staff. In a dental practice, this could be the health service contractor, practice owner or a person of similar authority.
The Code of Practice makes it a requirement that an individual is given the responsibility for infection control and decontamination. This person should have the experience and authority to perform this task and should be accountable to the Registered Manager.
This role acts as the interface between the practice and support services supplied externally, including service, maintenance and testing. This could be the general manager of the practice. The Decontamination Lead could also act as the Designated Person.
This is an external role that provides guidance and advice on the compliance issues of decontamination, including the implementation of this Health Technical Memorandum and associated guidance documentation. A list of suitable persons is available from the voluntary register held by the Institute of Healthcare Engineering and Estate Management (IHEEM) (http://www.iheem.org.uk/Technical-Platforms).
The Authorized Person provides technical support to the Competent Person and liaises with the Authorizing Engineer. The Authorized Person may be directly employed by the practice or provided by a third party.
The Competent Person is responsible for the servicing, testing and maintaining of the decontamination equipment within the practice. The Competent Person may be directly employed by the practice or provided by a third party.Competent Person (Pressure Systems):
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The DVP contains all the regulatory mandated documents. The hyperlinks and cross references between them make the package; not only unique, but also highly cost effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are presented formally. All the documents are written in MS word, to facilitate simple editing of text, layout, tables and schematics.
10002001. Validation Master Plan: (VMP). $115.00.
The VMP must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview, to a reviewer, of how the company has integrated all applicable cGMP requirements into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks.
10002004 Validation Plan: (VP). $115.00.
The VP must specify methodologies, assign staff, designate responsibilities and give specific guidance on any contentious or ambiguous aspects of the VP validation task. Where it makes commercial sense and is compliant with cGMP rules and regulations; each VP can be written to cover multiple items.
10002008 User Requirements Specification: (URS). $115.00.
The URS is produced once the product is established. With the product concept documented – then the design / recipe can be further analysed. From these investigations the requirements for facilities, utilities, maintenance, calibration, operator skills, software, documented specifications and engineering drawings can all be extracted and provisioned for.
Risk Based Validation was introduced to apply a level of validation that was adequate to maintain confidence in the qualification process; but would reduce unnecessary repetitive testing. The Validation Risk Assessment (VRA) was therefore designed to ensure that this level of validation is consistently used.
With a company approved VP and URS produced; vendors can be invited to submit submissions. These submissions will be challenged by the execution of a DQ; which will or will not certify that the vendor’s submission; if proceeded with, will fully satisfy all the requirements listed in the URS.
10002021 Combined Protocol: IQ-OQ-PQ. $169.00.
The Installation Qualification (IQ) section shall include test scripts that when executed shall verify that each testable requirement applicable to installation is fully complied with. The Operational Qualification (OQ) section shall include test scripts that when executed shall verify that each testable requirement applicable to Operation is fully complied with. The Performance Qualification (PQ) section shall include test scripts that when executed shall verify that each testable requirement applicable to performance is fully complied with.