GMPSOP

MAY 31, 2024

You can read our article “ Equipment Cleaning in Pharmaceutical ” to explore cleaning validation further. If you need help with complete guidance, please refer to the cleaning validation master plan. Method validation master plan? Create a master plan listing all products, specifications, and test methods.

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GMPSOP

OCTOBER 28, 2023

Validated test method A test method comprehensively describes all procedures used in sample analysis. Analytical test method validation guarantees that your test method is robust enough to provide evidence if your product meets the predetermined product specification or conforms to the failure of a product.

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GMPSOP

NOVEMBER 15, 2024

Stability and container closure systems Stability testing should be conducted on the proposed dosage form that is to be included in the container closure system (including, as appropriate, any secondary packaging and the container label). Accelerated testing can be performed on development, plot, and validation batches.

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GMPSOP

APRIL 3, 2023

There are also forms, logs, and registers to keep track of all the little details, as well as product specifications, analytical methods, manufacturing formulae, calculation of raw data and more. Sometime these are labelled as the “hidden factory”. Adapted and non-standard methods must be validated.

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GMPSOP

MARCH 4, 2023

If my cleaning methods are not validated would they cause contamination of my products? What is the probability my cleaning methods weren’t validated? Should I implement a more robust cleaning method validation to mitigate such risk? Packaging and labelling operations v. Manufacturing processes iv.

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