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Key Challenges and Solutions in Cryogenic Product Management

Cryogenics products contain cryogenic liquids that turn into gases under ambient temperatures. The word cryo- means “cold” and –genic means “producing”. Although cryogenic science is under the faculty of physics, it has wide applications in the field of medicine, materials science and electronics. Due to the changes in the state of matter with temperature change, the operations…

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ICH Multidisciplinary Guidelines

Drug development is primarily driven by three factors: quality, efficacy, and safety. The essential quality, nonclinical safety, and efficacy standards that are established by the assessment of the new drug's clinical efficacy and safety for its intended therapeutic indications in accordance with the ICH guidelines were covered in the previous few blogs. We'll concentrate on…

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Comprehensive Overview of ICH Safety Guidelines

To identify potential safety concerns such as unpleasant adverse effects of the medicines, ICH provides comprehensive guidelines that can be considered for therapeutic safety monitoring within the community. These safety guidelines are applicable during the non-clinical development of the new medicines. Safety assessment during the clinical trials and for the marketed medicines is considered under…

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Drug approval process in China

The People’s Republic of China is a huge pharmaceutical market and big pharma companies have been trying to get into the Chinese market for past few years. Recognising the need for new drugs for the people of China with an opportunity to develop indigenous industry, Chinese government over the years have made several policy changes to accelerate…

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ICH Quality Guidelines: What Every Pharmaceutical Professional Needs to Know

A global initiative called the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together powerful regulatory agencies from Europe, Japan, USA, and pharmaceutical companies to create guidelines and discuss the scientific and technical facets of developing pharmaceutical products and registering them. The goal of the ICH is to advance…

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What is Third-Party Manufacturing in Pharma and Its Benefits?

The manufacturing of pharmaceutical products by a third party is referred to as third-party pharmaceutical manufacturing, often known as contract manufacturing. A pharmaceutical company enters a contract with a specialised manufacturing facility to manufacture pharmaceuticals, medical devices, or other pharmaceutical items on their behalf. This production plan is available for large scale industrial batch sized…

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