This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.
How a proactive approach involving predictive — rather than preventive — tools to identify deficiencies before they compound and become actual problems can result in a healthy bioprocessing facility.
Changing existing or creating new documentation typically involves multiple disciplines and can have long lead times. CRB was able to help a biotech company improve their Global Documentation Change Control Process quickly and easily.
Is your team ready to manufacture larger batch sizes to support if Phase III studies are on the horizon?
Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. Read on to understand strategies, frameworks and recommendations to achieve these goals.
While there are a certain amount of commonalities in regulations in each country, there are differences which necessitate care from global manufacturers when distributing products.
Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.
The core of the KLD leak test method for vials is a low frequency high-voltage, which is applied to all surfaces of the test containers.
During the test, the containers are actively rotated by at least 360° on four independent and individually adjustable testing stations.
The latest version of the AFG stands for highest flexibility in sterile pharmaceutical powder filling into vials.
Designed and built to comply with and exceed FDA and GMP standards and to satisfy the demands of the pharmaceutical industry regulation, Pharma GF-PRO metal detection systems provide the ultimate in fully integrated product inspection and rejection systems for fine powders.
Designed and built to comply with and exceed FDA and GMP standards and to satisfy the demands of the pharmaceutical industry regulation, Tablex-PRO metal detection systems provide the ultimate in mobile, fully integrated product inspection and rejection systems for tablets and capsules.
The LyoCapsule Freeze Dryer is a lyophilization instrument that delivers results comparable to larger R&D freeze dryers enabling a Quality by Design (QbD) approach to cycle development even when materials are highly expensive or limited in quantity.
Reliability and transparency of production data are the basis of all planning. The EC-E checkweigher from WIPOTEC-OCS guarantees 100% data capture in ongoing production.
