Regulatory Affairs Officer Interview Questions and Answers for Freshers

The manufacturing process of solids involves several steps with in-process controls to ensure quality and consistency.

• Raw material selection and testing

• Granulation or compression

• Drying or curing

• Milling or sieving

• Blending and packaging

• In-process controls at each step to ensure quality and consistency

• Final product testing before release

Regulatory affairs involves ensuring compliance with regulations and guidelines in various industries.

• Regulatory affairs is a field that deals with the development, implementation, and compliance of regulations and guidelines in industries such as pharmaceuticals, medical devices, cosmetics, and food products.

• Professionals in regulatory affairs work to ensure that products and processes meet the necessary legal and quality standards set by regulatory authorities.

• They are resp...read more

ICH guidelines are a set of international standards for the development, registration, and post-approval of pharmaceuticals.

• ICH stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

• Guidelines cover topics such as clinical trials, quality control, and safety reporting

• Examples include ICH E6 for Good Clinical Practice and ICH Q9 for Quality Risk Management

ICH guidelines are a set of international guidelines for the pharmaceutical industry.

• ICH guidelines are developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

• There are several types of ICH guidelines, including safety, efficacy, quality, and multidisciplinary guidelines

• Examples of ICH guidelines include the Common Technical Document (CTD), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) gu...read more