Good documentation practices (GDP) describe best practices for creating and maintaining documentation in both paper and electronic format. These practices are used in pharmaceutical industry, medical device industry, and laboratories. It is basically a set of good...
Good clinical practice (GCP) provides guidelines for designing, conducting, recording, and reporting clinical trials that involve human participants. GCP sets standards that need to be followed by conducting clinical trials. It ensures that the rights, safety, and...
Outsourcing is becoming increasingly common in pharmaceutical, medical device, and biotechnology, industries, especially in regulatory affairs and pharmacovigilance domains. Large and small companies alike are now turning to outsourcing vendors to manage...
Snus is a cleaner alternative to cigarettes. It is an excellent choice for individuals who want to enjoy tobacco without smoking. Starting a snus manufacturing business can be profitable, owing to the increasing demand for the product. However, setting up a snus...
Performance qualification focuses on the practical application of the pharma equipment and system during manufacturing processes. Certain minor issues do not show up during the operational qualification phase. However, they can cause serious setbacks when the...