validation
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VALIDATION OF COMPUTERISED SYSTEMS
IN 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 ain’t written, it ain’t 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