What is Regulatory Affairs in pharma PPT?
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
What are pharma Regulatory Affairs?
Pharmaceutical Regulatory Affairs is a department in a pharmaceutical company that ensures that its organization complies with all of the regulations and laws pertaining to drug research.
What are the goals of Regulatory Affairs?
The goal of the regulatory affairs professional is the protection of human health, ensuring safety, efficacy, and quality of drugs, ensuring appropriateness and accuracy of product information.
What is DMF Slideshare?
DRUG MASTER FILES A Drug Master File (DMF) is a submission to the FDA of information, usually concerning the confidential detailed information about Chemistry, Manufacturing and Controls (CMC) of a drug product or a component of a drug Product.
What is QMS in pharma Slideshare?
QMS) – Quality management system – QMS helps in pharmaceutical to improve the product quality and minimize the risk of product recall – Quality management system a set of interacting elements based on procedures , policies ,resources and objectives that are established collectively to guide an organization.
What is regulatory work?
What is regulatory affairs? Regulatory affairs is an industry that oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use.
What is RA in pharma?
The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.
What is CPP in pharma?
A Critical Process Parameter (CPP) is a term used in pharmaceutical production for process variables which have an impact on a critical quality attribute (CQA) and, therefore, should be monitored or controlled to ensure the drug product obtains the desired quality.
What is CTD format dossier?
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States and beyond.