Regulatory 101: Drug Names – Reader Q&A

Medication errors occur in writing, print, speaking, and electronic communications; all of these modes must be considered in development of the drug name. The perspectives of health professionals with product name usage on a daily basis is far different than that of industry personnel who develop drug names for product recognition and commercial marketing.

A Humidex For The Cleanroom: Why Temperature And Humidity Control Matters

Temperature and humidity control are important factors to control within the cleanroom. For pharmaceuticals and healthcare products, this relates to three areas. The first is to avoid extremes affecting the skin of the operator, and hence the ability of the cleanroom gown to contain contamination...

Good Practices for Managing a Safe Chemical Laboratory Part 3: Safety Administration and Facilities

The Chemical Hygiene Officer must play an active role and have a strong presence in the lab, providing feedback and expertise and keeping lines of communication open between lab workers and management. The efficient facility run with good administration reflects a superior understanding of division of labor and conflict of interest. Although the operation may be seen from the outside as a large, well-lubricated machine, it is made up of many smaller parts and “safety” is one of the key lubricants.

Face Mask Controls and Duration of Wearing: What Medical Research Can Teach the Cleanroom Manager

No mask is 100% effective. Masks are a tradeoff between bacterial and particle efficiency and user comfort, with a 97.5% bacterial filter efficiency the typical rating. Achieving this is dependent upon the mask integrity and worn correctly. This paper covers cleanroom contamination control, more recent research within the medical field has been driven by responses to the coronavirus, and some recommendations for the control of surgical face masks worn in cleanrooms.

Understanding Adult Learning Principles, CGMP Training Modalities and the Pharmaceutical Regulatory Landscape

In this first article, we consider whether our CGMP learning programs providing the benefits that we are seeking; with effective knowledge transfer relevant to the adult learner in the CGMP environment. In the second and third article in this series, we will explore these questions, with actual examples to determine if the needs of the adult learner are being met.

Effective Knowledge Transfer During Biopharmaceutical Technology Transfer

While knowledge management (KM) has been widely applied in other sectors, the international biopharmaceutical sector has struggled with the meaningful and sustained application of effective KM practices. This is evident even though KM has been highlighted in regulatory guidance for over 10 years, and the positive business impact of KM is well recognized in other sectors. This paper focuses on the topic of KM as applied to biopharmaceutical technology transfer, introducing new research that explores the importance and effectiveness of knowledge transfer as an integral component of a biopharmaceutical product technology transfer. Results from multiple sources explored in this paper are well aligned in recognizing that knowledge transfer is very important to enable technology transfer, yet the biopharmaceutical sector is not very effective at this knowledge transfer. This is especially true of tacit knowledge transfer which is often reported to be ineffective. Additional research will further define the barriers to improve knowledge transfer effectiveness and how the biopharmaceutical sector might improve in this area.