page_title: Validation (drug manufacture)
section_title: The validation process
hierarchical_section_title: Validation (drug manufacture) / The validation process
caption_attribution_description: English: OPQ Adaptation of V-Model
context_page_description: Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
  Equipment validation
  Facilities validation
  HVAC system validation
  Cleaning validation
  Process Validation
  Analytical method validation
  Computer system validation
context_section_description: The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan.  These documents, terms and references for the protocol authors are for use in setting the scope of their protocols.  It must be based on a Validation Risk Assessment (VRA) to ensure that the scope of validation being authorised is appropriate for the complexity and importance of the equipment or process under validation.  Within the references given in the VP the protocol authors must ensure that all aspects of the process or equipment under qualification; that may affect the efficacy, quality and or records of the product are properly qualified. Qualification includes the following steps:
  Design qualification (DQ)- Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS).  Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.
  Installation qualification (IQ) – Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
  Operational qualification (OQ) – Demonstrates that all facets of the process or equipment are operating correctly.
  Performance qualification (PQ) – Demonstrates that the process or equipment performs as intended in a consistent manner over time.
  Component qualification (CQ) – is a relatively new term developed in 2005.  This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria.  This could include packaging components such as folding cartons, shipping cases, labels or even phase change material.  All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.
  There are instances when it is more expedient and efficient to transfer some tests or inspections from the IQ to the OQ, or from the OQ to the PQ. This is allowed for in the regulations, provided that a clear and approved justification is documented in the Validation Plan (VP).
  This combined testing of OQ and PQ phases is sanctioned by the European Commission Enterprise Directorate-General within ‘Annex 15  to the EU Guide to Good Manufacturing Practice guide’ (2001, p. 6) which states that:
  "Although PQ is described as a separate activity, it may in some cases be appropriate to perform it in conjunction with OQ."
caption: Figure 2: OPQ Validation Process (adapted from the typical V-Model)
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