Pharmaceutical companies are moving away from all-inclusive, in-house operations and partnering with Contract Development and Manufacturing Organizations (CDMOs) for solvent-based solid-dose manufacturing. When researching CDMOs, important considerations about the organization’s capabilities and processes should be assessed. Although the considerations reviewed in this white paper are not intended to replace the quality assurance standards that companies have in place, they provide a guide to increase the confidence you have in your manufacturing partner.
When moving into the commercialization phase, many basic business applications tend to quickly reach their limitations. Forward thinking manufacturers address these key business processes and requirements early on, in order to minimize growing pains while keeping up with exponential increases in production and federal regulations.
Considering replacing your existing ERP application or upgrading from spreadsheets? By understanding the key functions and architecture of a process-oriented, formula based ERP application, you will have a better foundation for choosing a solution that best suits your company and type of manufacturing.
In this collection four experts discuss several ways to reduce the risks of failed inspections, bad measurement practices, and poor product quality in controlled environments. Topics span from measurement accuracy, uncertainty, stability, and traceability, to a discussion of wired v. wireless connectivity for sensing instruments, to FDA inspection preparation and 483 responses. These articles offer a surfeit of tweaks, tips, and tricks for developing better quality management systems for GxP-compliant environmental monitoring applications.
Tubing used in pharmaceutical and biotech applications has particular requirements. Among them are the ability to withstand sterilization processes, the delivery of favorable test results regarding extractable substances, and the absence of animal-derived ingredients. These industries also have tubing needs involving flexibility, performance, and cost that are common to many applications.This white paper offers ten suggestions on what to look for and investigate when it comes to narrowing down your single use tubing selection.
GMP regulators in the United States, Canada, European Union, Japan, Australia, and China have sharpened their focus on warehouse storage and distribution practices and require “mapping” the temperature and relative humidity profile of warehouses for environmentally sensitive life science products. This step-by-step guide describes how to map a warehouse to comply with internationally recognized GMPs—including many that have been published or revised recently. It draws on Vaisala’s extensive experience in environmental and industrial measurement and monitoring throughout over 140 countries.
Testing for moisture in lyophilized materials has well documented benefits to ensuring quality and shelf life. It has been previously demonstrated that the Computrac® Vapor Pro® Rx is a perfect fit for testing for moisture in lyophilized samples. The samples can be tested in the lyophilization vials without ever being exposed to ambient air. The relative humidity sensor in the instrument is sensitive enough to allow for sample sizes as small as 5 mg.
About a decade ago, the debate about Single-Use Systems (SUS) vs. traditional stainless-steel was just a whisper: reusable steel was favored because it was the system that process designers and users had relied on for years. Then awareness of the cost savings and environmental benefits of SUS grew, and a shake up in the industry started.
Avoid Instrument Failure: Ensure Proper Filtration and Delivery of Samples to On Line Process AnalyzersFebruary 22, 2012 10:53 am | by Parker Balston
Precise process control strategies have accelerated the use of on-line chemical composition analyzers in plant applications. Contaminants in plant samples are the most frequent cause of problems with on-line analyzers. Trace contaminants can rapidly build up and cause instrument failure - DOWNLOAD WHITE PAPER.
Hazardous locations have or could potentially have high concentrations of flammable gases, vapors, combustible dusts, etc. A small spark can lead to a horrific explosion dangerous to equipment and workers in the area. Equipment located in hazardous areas must be specifically designed to prevent ignition and explosion. DOWNLOAD WHITE PAPER
If you manage a GxP compliant manufacturing facility, or oversee storage and distribution of regulated drugs and devices, this e-book is a convenient and comprehensive reference of definitions, helpful insights, and links to additional resources that will give you fundamental understanding FDA regulations and to achieving Good Manufacturing Practices and FDA compliance.
The Granurex® fluid bed conical rotor system utilizes multiple granulation and coating methods to produce spherical particles with a very uniform shape and size, particles with an exceptionally uniform coating, particles with multiple layers of coatings, particles with very high active content and particles with a high potency with yields of 97 % plus.
Performance Qualification of a New Hypromellose Capsule - Part II. Disintegration and Dissolution Comparison Between Two Types of Hypromellose CapsulesJanuary 10, 2012 7:02 am | by Capsugel
This Part II paper describes the disintegration and dissolution aspects of the qualification of a new hypromellose capsule (HPMC Shell 2). This new capsule does not contain any gelling agent, and is manufactured by a thermal gelation process. Rupture time of the carrageenan-containing capsule (HPMC Shell 1) and HPMC Shell 2, as measured by an improved real-time detection method, showed only slight differences that did not manifest in vivo.
The inhalation route is a fast and effective way of delivering medication locally to the lungs and also for the systemic administration of certain agents. Inhalation drug therapy is used extensively to treat respiratory conditions such as asthma and Chronic Obstructive Pulmonary Disease (COPD).
Remain informed about adjustments to MTSA and learn how the program continues to evolve. This paper provides regulatory updates on MTSA and information about Transportation Worker Identification Credential (TWIC™). Find out about new challenges, including harmonization with CFATS as well as practical tips for compliance.