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Best Practices

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Analytical Method Validation: 8 Key Parameters to Ensure Regulatory Compliance

  • Industry: Laboratory Compliance

Analytical methods play a key role in assuring that drug substances and drug products conform to their specifications. Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards since many years. Inadequacies in the validation process can incite FDA Warning Letters. 

 

What Does Good Laboratory Practice Mean?

  • Industry: Laboratory Compliance

Good Laboratory Practice, a regulation instituted in 1978, intended to regulate non-clinical laboratory safety studies. The outcome of these studies gave researchers the insight into safety of the new molecular entities for human trials or clinical trials.

The main laboratories that were affected by the regulation were ones conducting clinical chemistry, histology and pathology, which are used to analyze the samples generated from toxicology studies.

What are the aims of GLP? What are the key differentiators from other regulations? What are the various GLP organizational roles and their responsibilities?

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