INSIGHTS ON QUALITY ASSURANCE

  • Business Continuity Program: Maintain Operations During Crises

    Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

  • Quality By Design And Design Control Roadmap For Combination Products

    Quality by Design (QbD) principles help to facilitate design of products and processes that maximize the product’s efficacy and safety profile, while enhancing product manufacturability. A proposed roadmap to utilize QbD principles in conjunction with design control requirements (21 CFR 820.30 and ISO 13485) for design and manufacture of drug-device combination products based on sound science and risk management is presented.

  • What's The Difference When It Comes To Managing Quality?

    QA and QC are not identical or interchangeable, but you’re likely to have peers who don’t understand the distinctions between them. Read this blog to help such individuals solve the mystery behind these frequently conflated quality functions.

  • Aseptic Vial Filling

    We offer a unique range of formulation and aseptic filling in vials, prefilled syringes or cartridges to address production needs that span from small early stage clinical products to larger scale commercial products.

  • Quality Stability Testing: Oxygen Monitoring During Shelf Life
    6/3/2020

    A manufacturer of a syringe product received complaints about discolored product that was nearing the end of shelf life. A root cause investigation was started and product syringes were put on stability. The headspace oxygen levels were monitored over time. The laser-based headspace analysis proved to be a useful tool to check package integrity and for the presence of reactive headspace gases that can degrade the formulation.

  • Quality And Compliance In Times Of Crisis
    10/7/2020

    Already in 2020, the FDA has issued in excess of 50 warning letters to organizations that are COVID-19 related. During this webinar, see how the quality management systems of a life sciences company operate, how a collaborative secure deployment looks like and how it can be adapted to maintaining data integrity in order to deliver drugs to market quicker.

  • Moisture Headspace Analysis For Efficient Scaleup Of Freeze Drying Capacity And Validation
    10/21/2020

    A vaccine production facility needed to replace an old freeze dryer in an existing facility during running operations. Activity involved a scale up of freeze-drying capacity from 14 m2 to 28 m2. With the application of non-destructive headspace moisture analysis small scale proof of concept studies were used to minimize project risk and the number of full-scale runs in the freeze-drying validation process.

  • Analysis Of Laboratory Nitrile Gloves: From Pores To The Surface
    10/7/2020

    The humble rubber glove is usually the first line of protection for any person working with toxic, hazardous and contagious materials or environments. While everyone agrees on their universal use, very little attention is paid to the type of material, surface topography or pore size distribution of the glove itself. Here we describe an approach where the use of multiple techniques has enabled a complete physical characterization of the rubber glove material.

  • Unified Capabilities To Support Your Product Development Journey
    10/4/2021

    Through a breadth of facilities, resources, and experience, Grace’s FCMS can serve customers’ needs from coast to coast, ensuring supply chain efficiency, safety, and security throughout the product development journey.

QUALITY ASSURANCE SOLUTIONS

  • Thermo Fisher Scientific offers single-use and reusable sensors for the measurement of pH, DO, biomass, and headspace pressure along with The Thermo Scientific™ TruSens™ transmitter blade which is a combined technology designed to monitor all conventional pH and DO sensors.

  • Alconox, Inc. provides a range of validation information to help support the company's brands.

  • Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

  • The S-Cellerate™ to BLA platform offers the full spectrum of process validation services including well-designed process characterization (PC) and accelerated process performance qualification (PPQ).

  • The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.