Remove Compliance Remove Contamination Remove Life Science Remove Regulation
article thumbnail

GxP Best Practices for Safer, Smarter, Faster Clinical Research

Advarra

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

article thumbnail

BioNTech Unveils the BioNTainer, a Modular mRNA Vaccine Factory to Help Production in Africa

XTalks

The company also said that quality control is a crucial aspect of the manufacturing process, which is why it will help to ensure the identity, composition, strength, purity (including the absence of product- and process-related impurities) and absence of microbiological contamination of each batch that is produced.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Reliable Experts in Pharmacology Market: Pharma Consultants

Delveinsight

Especially in the field of Pharmaceutical & Life Sciences, a company’s all-around product life-cycle stages, which consist of planning, designing, constructing, product testing, and commissioning processes are provided by a Pharma Consultant. Pharma Consultant. Pharma Consultancy Modus Operandi.

article thumbnail

Cleanrooms-on-demand: a more efficient future for pharma?

pharmaphorum

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. And even once the facility is fit for purpose, specialised staff are required to maintain compliance with strict regulations. Meeting strict standards.

article thumbnail

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation. E&L testing is performed to substantiate that packaging materials will not contaminate the drug product over a product’s shelf life. shaking, changes in pressure, etc.). > umbrella).