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Good Manufacturing Practice (GMP)

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

whitepaper

Whitepaper: What Are Some Hidden Risks Associated with Isolators?

24 January 2024 | By Schedio

Uncover the pivotal role of isolator technology in enhancing safety and productivity in the pharmaceutical and chemical industries.

webinar

Applying ISO/TR 14644-21 – Airborne particle sampling techniques

23 January 2024 | By Particle Measuring Systems

Watch this webinar as GMP expert Mark Hallworth discusses the difference between cleanroom classification and monitoring of the new ISO 14644 Technical Report 21 focuses in section 4.0 and 5.2.

whitepaper

Whitepaper: Imaflow® Platinum Silicone Brewing in Coffee Vending

18 January 2024 | By

Imaflow® Platinum cured silicone tubing is heat resistant, flexible, and available with colour coded options (NSF-51 Certified for hygiene)

whitepaper

Whitepaper: Reducing gas consumption by 20% during the micronization

11 January 2024 | By Schedio

Discover how the coaxial jet mill transforms micronization in pharma and chemical sectors, ensuring safety, efficiency, and sustainability.

video

Video: Unveiling the science behind NGS

10 January 2024 | By Charles River

Virtual seminar presented by Christine Farrance, PhD, Senior Global Scientific Affairs Liaison of Microbial Solutions at Charles River designed to improve your understanding of how to leverage NGS to analyze the entire genome and mixed samples in a single, efficient test to identify, classify, and understand microbes in mixed and…

article

Cell and gene therapy: manufacturing and talent trends 2023

30 November 2023 | By Catherine Eckford (European Pharmaceutical Review)

In this interview, Stephen Ward, Chief Manufacturing Officer and Jeanette Evans, Chief Business Officer, Cell and Gene Therapy Catapult, highlight key data from the organisation’s recent GMP Manufacturing Survey and Skills Demand reports, and present insight into the sector’s current and future landscape.

whitepaper

Application note: Role of in-house isolates in pharmaceutical quality control

27 November 2023 | By bioMérieux

This application note addresses the need to evaluate key sources of contamination to maintain an optimum level of pharmaceutical quality control.

news

Novo Nordisk to expand French production facilities

24 November 2023 | By Catherine Eckford (European Pharmaceutical Review)

Using an investment of more than €2.1 billion, a planned expansion at one of Novo Nordisk’s strategic production sites will include additions such as aseptic production and the extension of its Quality Control Laboratory.

whitepaper

Product hub: Rapid mold detection in as little as one day

18 November 2023 | By Rapid Micro Biosystems

Quick to spread and difficult to detect, molds can compromise a facility in the time it takes to confirm their presence. The RMBNucleusTM Mold Alarm signals at the first sign of mold detection.

news

New acquisition to support global gene therapy manufacturing

14 November 2023 | By Catherine Eckford (European Pharmaceutical Review)

Acquisition of Forge Biologics by Ajinomoto Co., Inc. is set to extend global capabilities in AAV and plasmid gene therapy manufacturing for Ajinomoto, Co. Inc.

news

SGS ISL marks two-year anniversary

25 October 2023 | By SGS Health Science

We are thrilled to celebrate two years since International Services Laboratory (ISL) in Ringaskiddy, Cork, Ireland, became part of the SGS network.

news

Guidance on machine learning-enabled medical devices published

25 October 2023 | By Catherine Eckford (European Pharmaceutical Review)

The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have issued guidelines to reduce the regulatory burden for machine learning-enabled medical devices.

news

FDA issues draft guidance on alternative tools for facility assessments

17 October 2023 | By Catherine Eckford (European Pharmaceutical Review)

As part of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) reauthorisation negotiations, the US Food and Drug Administration (FDA) has issued new draft guidance on alternative tools for assessing drug manufacturing facilities.

news

Lonza to enhance commercial antibody-drug conjugate supply capacity

16 October 2023 | By Catherine Eckford (European Pharmaceutical Review)

A new cGMP filling line is set to be built at Lonza’s Stein site in Switzerland, expanding filling capacity and enabling the handling and filling of bioconjugates for commercial supply.

whitepaper

Whitepaper: Changing regulatory environment for nitrosamine impurities

13 October 2023 | By SGS Life Sciences

This whitepaper provides an overview of the regulatory challenges posed by the detection of nitrosamine impurities in pharmaceutical products.

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Good Manufacturing Practice (GMP)