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.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. The guidance document also emphasised semipermeable CCSs as another factor to consider in relation to E&Ls.

Documentation 83

Documentation Method Validation Packaging Labelling 83

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.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

JULY 23, 2023

Validation of testing methods: Validate all testing methods used during the qualification process to ensure the accuracy and reliability of results. Here are some common examples of equipment that you have to undertake installation qualification: i.

Documentation 52

Documentation Method Validation Packaging Labelling 52

Express Pharma

MAY 22, 2023

They recommend stringent guidelines to collect and propagate validated data on the safety, efficacy and claims made on the labels of nutraceuticals products.

Dosage 90

Dosage Method Validation Labelling Immunity 90

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.

Documentation 52

Documentation Communication Method Validation Packaging 52