VALIDATION OF

COMPUTERISED SYSTEMS
IN THE PHARMACEUTICAL INDUSTRY
Matt Safi
Product manager

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.

What is validated?

The Process of manufacturing a drug

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

Documentary evidence?

If aint written, it aint done

Sam Clarke (FDA inspector), 1993

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

Who is responsible for validation?

The manufacturer of a drug is responsible

for getting the process validated

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.

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

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

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

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

Cost of poor quality

Denial of product approval

Increased regulatory scrutiny

Seizure of product

Increased cost of implementation and maintenance

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

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)

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