In the manufacture of potent active pharmaceutical ingredients (APIs) and products, there is a need to conduct qualitative and/or quantitative healthbased risk assessments for both occupational and product (patient) safety purposes. When performed from an occupational standpoint, qualitative health-based risk assessments involve the categorization (“banding”) of the API based on toxicity and ...
An Overview of Setting Occupational Exposure Limits (OELs) for Pharmaceuticals Robert H. Ku, Ph.D., CIH, Principal Toxicologist [Published in Chemical Health & Safety, January/February 2000]
Setting appropriate occupational exposure limits is an integral component in assuring the health and safety of workers
Introduction Occupational exposure limits (OELs) 1 for the protection of workers have ...
These guidelines are used in designing experiments and planning the work that will be done to validate an analytical and sampling method for use in determining analyte concentrations in samples from Industrial Hygiene studies.
Occupational exposure and alleged health effects situations are complex and contain several components which may include physical, psychological and emotional effects on workers potentially exposed or effected. A thorough investigation is required with an objective of both solving the problem technically and communicating the risk effectively. Risk communication techniques are a learned skill and ...
It is a universal truth that research, development manufacture and formulation of potent active pharmaceutical ingredients (APIs) and products requires both “hardware” ( facilities, equipment and engineering controls) and “software” (programs, practices and procedures) to adequately protect personnel and the environment. When employing third party contracting organizations, there is a need to ...
The following is information compiled from recently published Technology Business Research reports.
Excerpts included in this release are:
· NetApp – Computer Business Quarterly
· Deloitte Consulting – Professional Services Business Quarterly
· Computer Sciences Corp. – Professional Services Business Quarterly
· Alcatel-Lucent – Network Business Quarterly
Quality by Design (QbD) is a systematic approach that begins with predefined objectives and emphasizes product and process understanding and control, by improving drug product development and minimizing costs and resources. The challenge for the pharmaceutical industry of the new century is a paradigm shift from “compliance” in industrial practices to a new way of designing quality. QbD rises to ...
Drug innovators, collaborators, licensing partners and the myriad of third parties who handle active pharmaceutical ingredients (APIs) need to take notice when the APIs they are handling have the following properties – clinical doses less than 10 milligrams causing pharmacological or toxic effects in patients or if low doses (less than 1 mg/kg/day) in laboratory animals may potentially be ...
All in the Execution: Keys to Superior Fee Income Performance
Heidi Hahn FIS Consulting and Professional Services
Keys to Superior Income Performance Keys to Superior Income Performance
Table of Contents ........................................ ........................ ........................................ ...............1 ........................................ ...
Chemical categorization (or banding) of inherent toxicity and potency linked with defined safe work environments including exposure controls has become an integral component of assuring the health and safety of research workers and manufacturing personnel in the pharmaceutical industry but is not a substitute for quantitative risk assessment in the workplace.
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