Technology Transfer: The Bridge Between Academia and Industry
| |

Technology Transfer: The Bridge Between Academia and Industry

The definition of technology transfer (TT) may vary depending on the type of TT. It is generally referred as bridge between academia and industry, though it may also involve transfer of knowledge within the industry. In the pharmaceutical industry, TT would very often include transfer of new product and process from development to manufacturing. It…

FDA Issues Final Rule Aligning Quality System Management Regulation (QMSR) with ISO 13485:2016

FDA Issues Final Rule Aligning Quality System Management Regulation (QMSR) with ISO 13485:2016

On January 31, 2024, the U.S. Food and Drug Administration (FDA) introduced a significant regulatory update through the issuance of the final rule for the Quality Management System Regulation (QMSR). This rule is aims to align the existing United States’ Quality System (QS) Regulation, as outlined in 21 CFR 820, with the internationally recognized ISO…

Therapeutic Vaping Products (Nicotine) – Changed Regulations in Australia

Therapeutic Vaping Products (Nicotine) – Changed Regulations in Australia

Public health concerns regarding vaping products Every year, more than 8 million people die from smoking-related illnesses, including 1.3 million non-smokers exposed to second-hand smoke. (Source: WHO 2023.) With the evolution of vaping products, including pharmaceutical nicotine vapes, cannabis vapes, and non-therapeutic vapes, people are curious to know if nicotine addictions and smoking-related health harms…

Risk-based thinking: Why does risk impact how medicines are supplied?

Risk-based thinking: Why does risk impact how medicines are supplied?

The ethos that high-risk activities should elicit the most significant mitigation effort, and low-risk, lower effort has been a mainstay of the global regulatory approach to risk management of therapeutic products for many years. In 2006, ICH Q9 Quality Risk Management was published and included the statement: The level of effort, formality and documentation of…

Why do Pharmaceutical Warehouses require a controlled environment?
| |

Why do Pharmaceutical Warehouses require a controlled environment?

Pharmaceutical warehouses are critical components of the pharmaceutical supply chain. A warehouse associated with a pharmaceutical manufacturing facility will typically be used for the storage of: Storage Condition Requirements for Pharmaceutical Warehouses Most of the pharmaceutical raw materials and finished products will have specified storage conditions requirements such as temperature, humidity, and light exposure. The…