It is vital that product safety information is collected, reviewed, assessed and reported to the highest standards
Failure to ensure product safety can ultimately result into:
• Affecting the well-being of patients
• Jeopardizing the key relationship between a company and regulators
• Jeopardizing reputation and share price of a company.
Quality by Design Program
The intention of Quality by design Program is to build the quality into a pharma product while it is still in the research and development phase to make sure that final product is going to meet with established standards long before it enters the production phase. One particular industry that has begun to invest heavily in the quality by design program is the pharmaceutical industry where many problems have been occurring with alarming frequency in recent years.
Quality by Design Training
The FDA has been quick to acknowledge the concept and recommend QbD training for all pharmaceutical manufacturers where so many quality issues have plagued the industry for years. Implementation of QbD training will result in far less need for heavy regulatory oversight and will help to streamline the development and manufacturing process.
Any biopharmaceutical products derived from animal or human tissues are needed to be tested to examine their ability to produce safe products to be used in human beings. Ensuring the inactiveness or absence of viruses is made mandatory by the regulators. However, the process of ensuring safety of the medicine and meeting regulatory expectations is expensive and at the same time complex too.
Radiopharmaceutical is a radioactive pharmaceutical or chemical component required for diagnostic or remedial purposes. Radiopharmaceuticals for injection require complying with the radiation protection regulations and also apposite regulations for working in aseptic condition. All these regulations have been covered in the Good Radiopharmacy Practice guidelines. Working with radiopharmaceuticals involves a great amount of risks and the risks depend on the types of emission and the half-lives of the radioactive isotopes.
Toxicology in Drug Development
A branch of medicine and biology studying the negative impact of chemicals on living organisms is known as Toxicology. Moreover, Toxicology is the study of symptoms, investigation, and cure of poisoning of human beings.
Not only for medical and biology, but often the concept of toxicology is used for other areas such as Aquatic toxicology, Chemical toxicology, Environmental toxicology and so on.