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Weighing Process ValidationAre You Up-to-Date?

Understanding and controlling the sources and impact of variations on product attributes is the goal of the validation process. Newly revised guidelines place considerable emphasis on this task.

Find out more on the latest regulations and how to improve the efficiency of the validation process.

All revised GMP guidelines describe the validation process in three main stages over the lifecycle of the product and processes.

Key Topics for Pharma Process Validation

01

0203

Warehouse Dispensing Room

Inventory Control

Filling / Formulation

Dosing / Blending / Batching

Inventory Control Commissioning

Quality Control

Completeness Control

Filling

Production

Packaging

Process Control

Warehouse

Weighing Processes in Pharmaceutical Production

Identifying criticalweighing steps

Documenting weighing equipment qualification

Continuously verifyingperformance ofequipment and ensuring it fits your process

Cleaning validation of weighing equipment

Validating of weighing software applications (e.g. formulation, SQC)

Weighing process validation

Defining weighingtolerances

Defining URS

Describing the weighingprocess

Requirements for Weighing Process Validation

Process Design Process Qualification Continuous ProcessVerification

Identification of Variables Control Strategy

Process Design

Equipment Qualification Computer Validation Cleaning ValidationProcess Validation

Process QualificationContinuous Process VerificationVerification Monitoring for Improvements