INSIGHTS ON QUALITY ASSURANCE

  • Getting Executive Backing For A Digital QMS
    8/26/2021

    This article offers guidance that will help you quantify and communicate the importance of quality, and how a digital QMS delivers considerable savings.

  • Formulation Development: Determining Oxygen Sensitivity
    6/3/2020

    Pharmaceutical formulations, especially delicate large molecule biopharmaceuticals, may have some level of oxygen-sensitivity leading to degradation of the active pharmaceutical ingredient. Laser-based headspace oxygen analysis enables accurate, efficient determination of oxygen consumption curves. Accurate measurement of the oxidation rate supports the determination of headspace oxygen specifications and end-of-shelf life stability.

  • Building Trust – Engineering To Quality & Validation
    12/21/2020

    Over the years, the roles and responsibilities of Engineering and Quality/Validation have evolved for Commissioning and Qualification (C&Q) activities. Quality is focused on the identification, mitigation, control of risks to product quality and verification of the process risk control strategy. Historically, the Quality unit has not had sufficient trust in Good Engineering Practices (GEPs) to facilitate their effective use in risk-based C&Q. Why has that trust been missing, and how can it be built?

  • A Fill Finish Manufacturing Partner With Resources, Solutions, And Agility
    6/1/2021

    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.

  • What's The Difference When It Comes To Managing Quality?
    8/27/2021

    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.

QUALITY ASSURANCE SOLUTIONS

  • Used Mettler Toledo analytical balance, model QD206DR, max capacity 220 g, serial# B428800942.

  • TQS-BP is perfectly equipped for the simple implementation of the first aggregation level. The system enables the serial numbers from multiple single packages to be combined to form one unique serial number for the set.

  • Precision and Versatility.
    Precision checkweigher delivering maximum brand protection with dedicated options for pharmaceutical process safety and functionalities supporting FDA 21 CFR Part 11 compliance and GMP requirements.

  • We have established a well-designed Supply Chain Management (SCM) — from raw material storage through work-in-process inventory to final API — to ensure that short time-to-market and long-term support are provided to our customers.

  • 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).