Risk Based Validation (RBV) was sanctioned by the FDA (along with EC and WHO) as soon as it became obvious that the scope of any validation task must be allowed to be adjusted to avoid over burdening companies with repetitive and or unnecessary tasks. However this was not meant to reduce validation intensity; only to render it more appropriate and targeted. The final defined scope of risk based validation activities must still be reviewed to verify it's adequacy.
We are all aware that risk assessment’s come in many formats; for instance, we have on our site a fully detailed; Failure mode and effects analysis (FMEA) template, which we use for all aspects of concept development and design development.
The Validation Online risk based validation - Online Risk Assessment (VRA) is a very different document and was specifically designed to assess and define the appropriate scope of any validation task. As such; it is a very important document which is mandated by the FDA and regularly reviewed by them. Is the scope of your validation adequate? Is probable the most important question in validation and the VRA must give assurance that it is.
The pit-fall(s) of using multiple event Risk Assessments (such as FMEA’s) is simply that there are not (in validation) multiple variations or answers available. At the validation stage the system / process / equipment / program has already been bought / built / written / installed and commissioned. All aspects of design / functionality / safety / operability will have been fully debated and integrated at the URS stage and reviewed and approved at the DQ stage.
Validation is the number one priority in most modern facilities, fall down on your validation and the regulators (FDA / MHRA / EMEA) can fine you, remove your approval to manufacture, or even close you down. Losing your manufacturing rights for a drug that has taken hundreds of millions to develop, is catastrophic, even to the major international companies. Good risk based validation ensures that this does not happen.
Validation is a mixture of skills, and the manual is designed to interlink with your existing skills and add the required mix of Quality, Instrument, electrical and mechanical knowledge to enable you to work as a validation technician or engineer or consultant in the pharmaceutical or biotechnological or API or Medical Device, industries. In validation you are not designing, you are verifying that equipment or installation conform to certain standards.
This involves authoring a document train that starts with the URS follows with IQ / OQ and usually finishes with the PQ, normally difficult and complex documents - but in your case - they are all in the manual Corporate Validation Manual DVD, ready for you to download. Using the manual is a great way to receive training while maintaining full time employment, and to feel confident that the manual has the answers or can point to where the answers are for any validation problem you may run into.
Whenever a new installation or changes or modifications are to be made to equipment used within a 21 CFR Part 210/211/820 compliant manufacturing, testing and or storage facility; a Validation Planᴬ⁴ (VP) must be initiated in order to document and authorize all the attendant responsibilities, scopes and associated requirements. This VP will also define whether the proposed change will use a single User Requirements Specificationᴬ¹ (URS) document for the change, or individual URS documents for all associated equipment allied to this proposed change.
The URS is such an important document that you can always be certain that time spent ensuring it is put together correctly, will pay dividends later in the risk based validation process. Initially the document will contain the high level requirements of the end user; laid out in a clear and unambiguous manner. In the URS each of these requirements must be detailed in a manner that will render them verifiable by the execution of a testing or inspection procedure. This high level document is titled URS-Level-1. The requirements in this Level 1 document must subsequently be broken down into activities. Then these activities must be further broken down into direct tasks and support tasks. This is an engineering responsibility and produces URS-Level-2. If the system uses software, the tasks detailed in URS-Level-2, must be translated into lines of code by the software writer, these lines of code must be attributed and constitute URS-Level-3.
These URS Level 2 and 3 documents were once part of the Functional Specificationᴬ⁷ (FS), however the mandated requirement for traceabilityᴬ⁷ from each requirement in the URS to the actual verification of compliance inspections or tests in the Performance Qualificationᴬ² (PQ), forced a step change to be initiated to enable compliance with the Full Life Cycle Requirements in risk based validation. Prior to this change; detailed traceability between the URS and the Design Specificationᴬ⁵ (DS) had become difficult if not impossible to achieve. The use of levels of URS now reinstates the required traceability and engenders good testing between design and protocol verifications. During these activities the URS must be maintained as an active document with each (of the 2 or 3) stages being reviewed and approved on completion.
With the URS completed and approved, the procurement process can commence. When the successful design (or product, if off the shelf item is chosen) is known, its design must be subjected to the execution of a Design Qualificationᴬ³ (DQ) which will be used to verify that this proposed procurement will satisfy all the documented requirements in the URS.
The completion of the DQ allows the procurement process to complete and the ’hands on’ stage of the risk based validation process to commence. Next we must execute a Validation Risk Assessmentᴬ⁶ (VRA). This is often the most abused and misunderstood document in the validation process. The VRA is in place because the regulators have decreed that we must produce, and hold for regulatory inspection, a documented justification for the scope of validation activities we have deemed to be appropriate in our planned risk based qualification. They expect this justification to take the form of a risk assessment. This makes the VRA a very meaningful document. Your VRA must consider all the regulatory requirements and define a level of risk based validation intensity that is cost effective to the end user, while being appropriate to the sophistication of the equipment and acceptable to the regulatory authorities.
Since the execution of the VRA will define the scope of validation; its execution, will allow the protocol authors to commence authoring the Installation Qualificationᴬ³ (IQ), the Operational Qualificationᴬ⁵ (OQ) and the Performance Qualification (PQ). All based on the findings of the risk based qualification execution.
Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your Risk Mitigation in Validation template.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.
The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; The User Requirements Specification template
The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (IQ), takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification template. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template.
You will find this validation online intuitive Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.
This Validation, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. Resulting in the document becoming notably easier to use and quicker to review and amend. This new format will make a very significant difference to the man hours required to produce and execute these documents. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document. This is an essential step forward for companies seeking to reduce validation costs without sacrificing regulatory compliance.
4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining validation documentation by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks. For everyone's convenience, it is still written in word.
This quite revolutionary two document package is all that is required to fully validate; to cGMP standards, equipment used in a regulated facility. A lot of effort has gone into ensuring that repetitive instructions and actions have been designed out and innovative and intuitive risk-based methodologies have been incorporated. Both documents are prefaced with a methods Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; 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 written in MS word, to facilitate simple editing of text, layout, tables and schematics.