Equipment qualification or validation as required by the FDA, requires verification documentation to start with the Validation Master Plan (VMP) and flow through a series of documents that define the scope and tasks required to successfully execute your equipment qualification task. The VMP dictates the actions that all persons involved in equipment qualification projects must comply with. The Equipment Validation Plan (VP) may often be designed to include more than one piece of equipment. The list of equipment will be appended to the plan. Each of these items will have its own stream of documentation; typically,
The VMP is not mandated by the FDA, but is always asked for in regulatory reviews and inspections. (URS - DQ - VRA) are mandated and self explanatory.
With the Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (P1Q) and Process Qualification (P2Q), there is a degree of flexibility as regards to the content of these documents. Although the document title clearly defines it’s scope, it is possible and permissible to arrange some elements of testing in the most expedient sequence. I.e. do you wait for power 'on' to do IQ, perhaps? Perhaps not? It can be argued that when power is on you are operating the equipment (so power on testing should be in the OQ). Can IQ therefore be completed prior to power up?
It can, and often is, hotly
debated whether all the testing carried out in the FAT, SAT and commissioning stages, must be
repeated in the equipment qualification. (i.e. are you going to repeat some
of the testing four times?) This is where the VP becomes a vital document.
Senior persons with a good understanding of the overall project, can decide the content and scope of each of these documents, obviously within the framework of existing cGMP legislation and guidelines. They can actually develop a quite unique sequence of equipment qualification tasks for a number of reasons (to reduce repetitive testing - to ease access problems – to sequence with other activities, and on), providing that their rationale is documented in the VP and posts a plausible justification.
The VP is then used by the protocol writers as the official mandate for protocol content.
In the diagram below it can readily be
seen that the URS, along with the regulatory requirements as detailed in
GAMP 5, and the details of validation requirements as given in the VMP,
to form a package from which the vendor can develop a fully legal,
compliant and validateable product.
Equipment qualification templates are available for the activities shown grouped in the two colours (orange and blue). The blue color is the requirement for standard computer validation, while the orange color depicts the additional equipment qualification templates that are required when the process executed by the during equipment qualification has been identified as critical.
The FDA regulators have decreed that software used in a manner that can affect the quality of the product, without leaving visible evidence, that damaged has occurred, must be deemed as critical to the quality of that product.
The regulators have further mandated that all such software be identified as such - and subjected; from concept to actual use, to Full Life Cycle Validation (FLCV) requirements. This additional level of validation requires the addition of further validation GMP qualification templates as portrayed in the diagram in orange.
The vendor therefore (be they in, or out, of house), must produce a Quality Plan that ensures the software development will follow a validation evolution similar to that shown in the diagram. Your actual diagram must be planned and justified for the software system that you are proposing.
It is of paramount importance that your decision on software criticality is documented and that your Quality Plan (QP) is reviewed, approved by QA, the client & their representative; all prior to initiation of the design stage. Since these documents all form part of the equipment qualification-evaluation stage, you must expect regulatory inspectors to be interested in reviewing the content and the format of them.
required FDA Compliant documentation must be carefully prepared, with
statements worded to preclude ambiguous and incorrect interpretations of
of the statement. In addition there are quite separate requirements
stipulated by the regulatory authorities. Documents presented to
regulators during inspections that fail to satisfy these requirements,
indicate to the regulator a lack of care and commitment on the
part of the company. The exact opposite to what is required.
The FDA and regulatory authorities in general, are charged with increasing the level of compliance throughout the industry. This call for increased regulatory compliance, is driven by evidence that the industry is failing to match the standards set by other regulated industries.
Validation Online, have designed unique interactive documents for all validation activities such as VMP, URS, IQ, OQ, PQ, and many others. These documents have all been designed to be cGMP, compliant, along with incorporating the structures the regulators look for. These documents are realistically priced to ensure it is much more cost effective for companies to download documents as they require them, than individually author them.
Generally there is only one Validation Master Plan (VMP); although a case can be made for using two, if there is sufficient equipment to justify it. The Validation Plan (VP); on the other hand, is design to collect together identical equipment. Although the IQ / OQ / PQ protocol tests and inspection would be written in once; the execution results, would be tabletized.
When goods or services are purchase by a cGMP approved organization from a none cGMP approved vendor; it is a legal requirement that the would-be purchaser audits the supplier to establish the scope of any work required to render the item or process cGMP compliant
This elevates the Vendor Audit (VA) Document to a “Must be in Place” status. So, your list of pre validation doc's must include: (VA) + (FAT) + (SAT)
These are mandatory & available as a package;
The Validation Plan (VP), is the starting point for any validation task, and the most important validation document. It greatly improves validation efficiency by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is a mandated document with regulators and auditors.
While in the past validation was more focused on functions of procedures, recently the focus has progressed into infrastructure, networked systems and on security, authenticity and integrity of data acquired and evaluated by systems.
This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or driven systems.
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 validation activities. The 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).
The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.………………………………………………… Validation Plan (Issue 10) -- $93.00
The Installation Qualification (IQ) execution; verifies that the equipment, and its ancillary systems or sub-systems have been installed in accordance with installation drawings and or specifications. It further details a list of all the cGMP requirements that are applicable to this particular installation qualification. These requirements must all be satisfied before the IQ can be completed and the qualification process is allowed to progress to the execution of the (OQ).
You will find the step by step attached SOP 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 Operational Qualification Protocol. 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. Template for VMP.
P1Q is performed after successful completion of the Installation qualification (IQ) and Operational Qualifications
(OQ) execution. The testing carried out is targeted at verifying that
the performance specified in the URS is being delivered. Verification is
also required to confirm the requirements specified in cGMP’s, health
and safety rules and other guidance documents is complied with.
Whether your processes is controlled in batches or are of continuously monitored production runs; the same basic requirement exists - At all stages in process validation, staff must work from detailed documented SOPs. Each production process and all associated process equipment must be validated and so must all the equipment, used in the execution of these processes. Caution must be used to ensure that all of this equipment is adequately labeled and supported by completed company approved validation protocols.