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Run: In-Process Quality Control Checks for Solid Dosage Forms

In-process quality control checks for solid dosage forms, including tablet weight variation, hardness, friability, and disintegration, so you can catch drift...

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Batch and Line Identification

Batch record, product name, and batch number match the current run critical (required)

Yes No N/A

Tablet press or manufacturing equipment ID is documented

Sampling time and location are recorded

Approved specification or master batch record reference is available at point of use critical (required)

Yes No N/A

Tablet Weight Variation

Sample size for weight check meets SOP requirement

Average tablet weight is within acceptable range critical (required)

Individual tablet weights are within approved variation limits critical (required)

Yes No N/A

Weight adjustment or press setting change documented when trend indicates drift

Yes No N/A

Tablet Hardness and Mechanical Integrity

Hardness test performed using calibrated instrument critical (required)

Yes No N/A

Hardness result is within acceptable range critical (required)

Tablets show no visible capping, chipping, cracking, or lamination critical (required)

Yes No N/A

Photo evidence (optional)

Hardness trend is reviewed against prior in-process readings

Yes No N/A

Friability and Disintegration

Friability test performed per approved method critical (required)

Yes No N/A

Friability loss is within acceptable limit critical (required)

Disintegration test performed per approved method critical (required)

Yes No N/A

Disintegration time is within acceptable limit critical (required)

Documentation, Deviations, and Release Hold

All IPQC results are recorded legibly and traceable to the batch record critical (required)

Yes No N/A

Any out-of-specification result or non-conformance is documented critical (required)

Yes No N/A

Production hold or escalation to QA is initiated when required critical (required)

Yes No N/A

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