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FOR INTERNAL USE ONLY

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DSM Specific Quality TRACC Portal (OKP) on OKP

DSM_VM

Validation Management

Why

What is the importance of validation?

It is all about standardization, in order to achieve the same outcome and a product within the
specification.

Validation of processes and qualification of equipment is important to ensure a standardized outcome.

The process should always function in the same way to come to the same and reproducible result,
producing the specified product within certain pre-defined limits.
A validation and qualification should always include a risk assessment to define the worst case
scenarios and cover them during the validation/qualification steps.

Depending on the maturity level the following should be in place:

Level 2: Controls are in place to ensure that processes and products meet specified requirements.
 An incoming goods control is in place. Results are recorded.
 In-process-controls are in place. Results are recorded.
 A Quality control (end control of final product) is in place, a review of the results in
comparison with the specified requirements is executed.
 Processes are defined, including KOPs and quality critical parameters.
 The processes are standardized in order to always achieve the same outcome.

Level 3: Documented qualification of equipment having a direct impact on the quality of the final
product (e.g. production, laboratory. warehouse) is in place.
 The validation & qualification strategy is defined.
 The processes for validation are identified (production, cleaning, method, transport,
computerized systems).
 The quality impact of the processes are known and taken into account for the worst case
considerations.

Level 4: Validation strategy for applicable areas/topics is available and implemented, the needs of re-
validation are assessed.
 A validation master plan is present for the plant/entire site?
 Validation/qualification experts are present on site/in the network?
 The necessity to qualify all new equipment is assessed.
 The necessary qualification steps (DQ, IQ, OQ, PQ) are developed in a qualification plan.
 A revalidation approach is defined.
 Failure of revalidation requires retrospective quality impact analysis.

Level 5: Validation management is part of the continuous improvement plan.

 The review of validation/qualification results are part of the management review.
 Improvement actions are defined derived from the management review.
 Revalidation intervals are defined and reviewed.
 For Internal Use Only
FOR INTERNAL USE ONLY

Example of a Good Practice is Validation policy of DSP: