pharmaphorum

DECEMBER 16, 2021

Gain insight the current state of Endotoxin testing, including alternative test methods and strategic approaches to method validation. Event Hashtag: #SMiPharmaMicroUK. Explore the best practice in data integrity and the automation of environmental monitoring in the Microbiology Quality Control Lab.

Method Validation 52

Method Validation 52

Pharmaceutical Technology

AUGUST 24, 2022

The advantages of FCM over other methods include: Comprehensive data: Using a single tube of blood, researchers obtain information on immune cell subsets, memory phenotype, activation, regulatory exhaustion, and more. High throughput: Flow cytometers can measure more than 35,000 events per second (and counting).

Method Validation 52

Method Validation Immunity Immunization Drug Development 52

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.

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. Additional documents included each month.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

APRIL 3, 2023

Adapted and non-standard methods must be validated. Protocols are only used for specific projects such as method validation testing or equipment qualification. – Methods for data analysis and interpretation, including the statistical techniques to be used.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

GMPSOP

DECEMBER 24, 2023

Laboratory documentation and records that should be available include: – Test methods and test reports – Laboratory notebooks/sheets, instrument records, and calculations – Conditions of tests and instrument settings. – Test method validation protocols, data and reports – Other records and data i.

Documentation 40

Documentation Method Validation Packaging Data Entry 40

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