VALIDATION OF COMPUTERISED SYSTEMS IN THE PHARMACEUTICAL INDUSTRY

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VALIDATION OF COMPUTERISED SYSTEMSIN THE
PHARMACEUTICAL INDUSTRY

• Matt Safi
• Product manager

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What does need validation?

• Any drugs manufactured for use by humans and
  animals needs to be validated.
• A satisfactory inspection and approval by a
  regulatory inspector is required before a drug is
  released for sale.

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What is validated?

• The Process of manufacturing a drug

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What is Process Validation?

• Validation is documented evidence that provides
  a high degree of assurance that a specific
  process will consistently produce a product
  meeting its predetermined specifications and
  quality attributes
• 
  FDA

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Documentary evidence?

• If aint written, it aint done
• Sam Clarke (FDA inspector), 1993

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Principles of validation

• Document what is to be done
• Document how it is to be done
• Do it
• Produce documented evidence that it was done in
  accordance with the how
• Demonstrate that it remains in a state of control

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Who is responsible for validation?

• The manufacturer of a drug is responsible
• for getting the process validated

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What is FDA validation?

• FDA (Food Drug Administration) is responsible
  for granting approval for drugs intended for the
  use by humans and animals within the US.

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Does every drug need FDA validation?

• No, only drugs which are intended for use within
  USA.
• Generally every country has its own regulatory
  body
• MCA (Medicines Control Agency) regulatory body
  in the UK.
• FDA has the most stringent requirement

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Can a Computerised system claimed to be FDA
validated?

• No. Only the process can be validated.
• If a system has been used in a validated process
  then it will help the validation process

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Regulators requirements

• Computerised systems installed in pharmaceutical
  companies are fit for their intended purposes (in
  the context of relevant GMPs) by considering
• Quality assurance of the development life-cycle
• Performance validation
• In-use controls
• Accuracy and reliability

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Pharmaceutical Company Requirements

• Computerised systems requirements
• Quality assured, robust, reliable system
  delivered on time within budget
• Meet functional and business targets
• Acceptable to regulatory agencies
• Ease of maintenance

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Cost of poor quality

• Denial of product approval
• Increased regulatory scrutiny
• Seizure of product
• Increased cost of implementation and maintenance

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What is our responsibility?

• Ensure that the supplied automation system
  satisfies the requirement specification
• Provide documentary evidence.
• Documentary evidence will be integrated with the
  overall documentation for submission to the
  inspector

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Some of the regulators

• FDA Federal Drug Administration (US)
• HPB Health Protection Branch (Canada)
• Irish Medicines Board
• MCA Medicines Control Agencies (UK)
• TGA Therapeutic Goods Administration (AUS)

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Some of the regulations guidelines

• EU 91/EEC/44-356-412 Good Manufacturing Practice
• CFR 201/211 Current Good Manufacturing Practice
• FDA Guide to Inspection of Computers Systems
• FDA Guide to Soft ware development
• FDA Compliance Policy Guidelines
• FDA Computerised Systems in Clinical Trials
  (Draft 1998)
• APV Interpretation of Annex 11 (1996), 91/EEC/356
• GAMP Guide
• PDA Technical Report 18- Computer Validation