Pharmaceutical Online

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Pharmaceutical Online

 •  October 19

Industry Insights What You Need To Know To Avoid Costly Delays In Your API Scale-Up Article | By Peter Poechlauer, Patheon If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, they can prevent a company from delivering a product with reliable quality and efficacy. Improving Manufacturing...

Pharmaceutical Online

 •  October 18

If you are charged with any of the tasks that lead to a successful product launch in the pharmaceutical industry, you know how critical it is to execute a multitude of steps successfully. Among these are agreement by marketing on the look and design of the campaign, completion of clinical trials, project management, testing of active pharmaceutical...

Pharmaceutical Online

 •  October 17

Industry Insights 8 Strategies To Ensure Successful Retrofit Of Pharmaceutical Manufacturing Automation Systems White Paper | By Richard Parapar, Schneider Electric Software This paper presents a range of proven best practices and project strategies for performing major system retrofits in GMP manufacturing facilities, using the successful case...

Pharmaceutical Online

 •  October 17

A biosafety cabinet (BSC) is one of the most important pieces of equipment a laboratory that handles low-to-moderate risk biological materials. A BSC maintains a safe environment for personnel, and prevents cross-contamination of the work product. Among the many components determining the effectiveness of a BSC, the most critical is the air filter.

Pharmaceutical Online

 •  October 16

Investing in training for employees in the life sciences and biopharmaceuticals industries generates quantifiable returns that go far beyond simply imparting specific, task-oriented knowledge. For example, effective and thoughtfully planned onboarding and sustainable training are key elements in attaining a culture of quality throughout the...

Pharmaceutical Online

 •  October 14

Biological Safety Cabinets Have A 15 Year Useable Life Several considerations should be made of BSC’s in this age group. Will the BSC need extensive service? (i.e. HEPA filter replacement, blower/motor replacement, will the electrical wire harnesses need replacement? etc.). Can an older BSC be commissioned after it has been in storage or purchased...

Pharmaceutical Online

 •  October 13

Welcome to the second in a series of three application notes to assist end users in understanding guidance detailed in EU GMP Annex 1 it follows on from directly from Part 1. In Part 1, introductory paragraphs up to and including section 3 were covered. In Part 2, sections 4 to 7 detailing cleanroom and clean air device classification will be...

Pharmaceutical Online

 •  October 13

Microbial control for non-sterile manufacturing helps to ensure the safety and efficacy of pharmaceuticals. Products that are compromised with excessive amounts of microorganisms, specified microorganisms, or objectionable microorganisms may not be effective or could be dangerous to consumers. Unfortunately, the regulations governing non-sterile...

Pharmaceutical Online

 •  October 12

Industry Insights How To Prepare For Chamber Mapping In Life Sciences: 8 Critical Steps Article | By Bruce McDuffee, Rotronic Instrument Corp. Most chamber mapping projects that fail do so because of inadequate preparation. Poor or inadequate preparation for the mapping study can lead to a failed mapping study, which can lead to unnecessary costs...

Pharmaceutical Online

 •  October 11

There is a trend within the pharmaceutical, biopharmaceutical, medical device, and vaccine industries to hire more consultants, leading to a staffing ratio that can be up to 50 percent consultants to staff for small to large capital projects. This is done to accommodate the need to complete projects within as tight a timeframe as possible, as...