Process performance Protocol


-A written protocol that specifies the manufacturing conditions, controls, testing, and expected outcomes is essential for this stage of process validation. We recommend that the protocol discuss the following elements: 

-The manufacturing conditions, including operating parameters, processing limits, and component (raw material) inputs. 

-the data to be collected and when and how it will be evaluated.

-Tests to be performed (in-process, release, characterization) and acceptance criteria for each significant processing step.

-The sampling plan, including sampling points, number of samples, and the frequency of sampling for each unit operation and attribute. The number of samples should be adequate to provide sufficient statistical confidence of quality both within a batch and between batches. 

-The confidence level selected can be based on risk analysis as it relates to the particular attribute under examination. Sampling during this stage should be more extensive than is typical during routine production. 

-Criteria and process performance indicators that allow for a science- and risk-based decision about the ability of the process to consistently produce quality products. The criteria should include: 

-A description of the statistical methods to be used in analyzing all collected data (e.g., statistical metrics defining both intra-batch and inter-batch variability). 

-Provision for addressing deviations from expected conditions and handling of nonconforming data. Data should not be excluded from further consideration in terms of PPQ without a documented, science-based justification.

-Design of facilities and the qualification of utilities and equipment, personnel training and qualification, and verification of material sources (components and container/closures), if not previously accomplished. 

-Status of the validation of analytical methods used in measuring the process, in-process materials, and the product. 

-Review and approval of the protocol by appropriate departments and the quality unit.

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