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FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

The event began with a keynote address by Dr Y K Gupta, President, AIIMS Jammu, and Principal Adviser, GARDP (Global Antibiotic Research and Development Partnership). The panel also discussed the role of analytical method validation when outsourcing testing and the necessity of Excel sheet validation.

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A rapid microbiological method case study for advanced therapy medicinal products

European Pharmaceutical Review

The implications of this publication are that the bar for the use of alternative methods is lowered for the products that could benefit from them the most, and in turn, benefits the patients who need therapies as quickly as possible.

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SMi’s 10th Annual Pharmaceutical Microbiology UK Conference

pharmaphorum

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.

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Flow cytometry: advantages in immunotherapy clinical trials

Pharmaceutical Technology

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).

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Ethical Nutraceuticals: Need of the hour

Express Pharma

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.

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What are the elements of quality control process in pharmaceuticals

GMPSOP

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.

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Typical GMP documentation in a quality control laboratory

GMPSOP

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.