Express Pharma

MAY 22, 2023

This, in turn, led to a discussion on the role and importance of a surveillance system akin to the pharma industry to monitor and record adverse events associated with nutraceuticals. They recommend stringent guidelines to collect and propagate validated data on the safety, efficacy and claims made on the labels of nutraceuticals products.

Dosage 105

Dosage Method Validation Labelling Immunity 105

GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. Validated test method A test method comprehensively describes all procedures used in sample analysis.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

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

GMPSOP

MARCH 4, 2023

Quality risk management involves the art and science of identifying, analyzing, assessing, and managing uncertain events. Events that can impact product quality or compliance with registered dossier throughout a product’s life. In most cases, these questions need to be asked before a risk event would potentially occur.

Documentation 52

Documentation Communication Method Validation Packaging 52