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QUALITY CONTROL OF BIOTECHNOLOGICAL PRODUCTS

Course introduction • quality systems • laboratory analytics

QUALITY

CONTROL

of biotechnological products

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Standards and compliance

ISO-based systems define requirements and competence

ISO 9000

ISO 9001

ISO/IEC 17025

Quality management • requirements • laboratory competence

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Validation: proving fitness for purpose

An analytical method must be demonstrated to work reliably

PLAN

TEST

ANALYSE

DOCUMENT

APPROVE

Specificity

Linearity

Accuracy

Precision

Robustness

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Measurement quality

Accuracy, precision, selectivity and traceability

TRUE VALUE

MEASURED VALUE

REPEATABILITY

TRACEABILITY

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The analytical workflow

From sample receipt to approved result

RECEIVE

PREPARE

TEST

REVIEW

REPORT

RELEASE

Every step must preserve sample integrity and data integrity.

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Chromatography in quality control

Separate • identify • quantify

A separation-based analytical technique

Different analytes produce different retention behaviour

Signal patterns support identification and quantification

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