What are the General principles on Process Validation

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What are the General principles on Process
Validation
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• In 2011, the FDA clarified and consolidated the
  general principles on process validation. The
  inseparability of Quality from process validation
  (PV) has been emphasized in this update.
• In simple terms, the FDA deems PV to have been
  met when a product shows performance in the
  quality of every unit in every batch consistently.

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Quality, product lifecycle and control -the
tripod of process validation

• Of equal importance as quality is the
  inextricable link of the product lifecycle to
  process validation. That is, quality is not
  something that has to be demonstrated in every
  unit of every batch of the product for a
  stipulated period of time it has to be
  implemented throughout the lifecycle of the
  product.

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• In addition, process validation Quality has to be
  maintained in every unit of every batch of a
  product throughout its lifecycle while the
  product is being produced in a state of control
  throughout the production stages. To make sure
  this happens, there has to be control at every
  stage of production. The FDA believes that it is
  not enough to simply inspect the product during
  production or after it.

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• Process validation can thus be thought of as
  being a tripod whose legs consist of three
  crucial principles -quality, lifecycle approach
  and control. These are bound to the product and
  process development of the commercial
  manufacturing process.

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Points to ponder about process validation

• With regard to the FDA's thinking relating to PV
  the following points need to be borne in mind
• According to the FDA, process validation has only
  a start, and no end, i.e., it stops only when the
  product's production gets discontinued
• Knowledge about process validation is gained as
  the organization gets engaged in commercial
  production

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• A well designed, thorough and comprehensive
  process design has to be put in place to get a
  grasp of the sources of variability and to
  understand the process
• Risk management has to be infused into the veins
  of process validation.

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Process validation's three stages
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The FDA's general principles on process
validation sets out three stages

• Process design The stage which throws up the
  knowledge needed for process development
  activities to get expanded into commercial.
• Process qualification The stage that confirms
  the capability of the process design to engage in
  commercial manufacturing repeatedly and
  reproducibly

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• Continuous process validation The stage which
  confirms the presence of control in the
  production capability. Maintenance, continuous
  verification, and process improvement are the
  ingredients that go into this.

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