The validation plan is a central part of process qualification documentation. Process qualification (PQ), or Stage 2 of the US Food and Drug Administration lifecycle approach to process validation, is what the industry recognizes as traditional validation. Validation documents are always requested in regulatory audits and inspections. FDA often requests the documents in advance of the actual inspection. Other Stage 2 documents include the validation request, validation protocol, engineering studies, and the validation results. Because the validation plan is the comprehensive explanation of the validation process, many professionals consider it the most important document in Stage 2 of the lifecycle approach to process validation. Below are the five sections of a validation plan and what should be included in each section.
Note: The following was taken from a presentation given at IVT's 4th Annual Validation Week EU by Paul Pluta, Ph.D.
The introduction in a validation plan is the overview describing the process, product, or equipment validation, and it should be consistent with the validation request. It will outline the requirements to complete the validation. Requirements include conformance to regulations and internal policy; the impact of a change to maintaining the validated state; any impact on regulatory submission; impact of the change on procedures, drawings, and other documents; and notifications to internal and external groups impacted by the validation.
2. Technical Information
The technical information will include a description of the product, process, or equipment, including any relevant formulae and specifications. Any technical aspects of the validation or qualification should be included in this section along with any references to the Stage 1 technical reports.
The total validation approach should also be included. This is determined from what is known from experiment studies and past data. Anything that will make one’s validation stronger will go into this section.
The total number of lots to be sampled will be included in this section, and the associated risk will be described.
3. Validation Strategy and Testing
The validation strategy and testing will include the general types of testing that will be performed, including the regulatory specifications, internal controls, and process tests. The rationale for the test as well as the sampling will also be described, all of which should be based off of a risk analysis.
How the data will be treated statistically with confidence limits will be described, and a general overview of the acceptance criteria should be discussed.
It is important to consider that the details of the topics in this section will be discussed in the validation protocols. Remember, the validation plan is high-level, a birds-eye view.
4. Validation Documentation
A list of required documents for the entire validation should be include in the plan. Identifying and assigning a number to every document needed the validation will ensure no protocols are left outstanding. This section will provide administrative assistance in understanding what needs to be completed to finish the validation and guaranteeing that those responsible do so. This section primarily will help validation practitioners organize and determine the necessary steps in a validation process that need to be identified and documented.
The reference section will include the list of any Stage 1 documents that support validation. This is the connection between Stage 1 and Stage 2. Some examples of documents included in the references are R&D technical reports, formulation and process development reports (CQA, CMA, CPP), and technology transfer or scale-up reports.