To get FDA approval for your company, you’ll need to ensure compliance with the FDA’s regulations and guidelines. The FDA doesn’t approve facilities, but rather the products they manufacture ¹. Here’s a step-by-step guide to help you through the process: Registration and Listing Product Approval Compliance with Regulations Inspections and Audits Additional Resources Remember, FDA…
Q. Why is cleaning validation important? Cleaning validation ensures: Q. Is cleaning validation required for dedicated equipment? Yes, as long as any piece of equipment or manufacturing system is used in the production, processing, packing, or holding of drug products, cleaning validation is required. Q. When is cleaning validation required? Q. What is the difference…
Biochemistry is the study of chemical processes in living organisms. It combines biology with chemistry, physics, mathematics, microbiology, and genetics to understand how life works at the molecular level. Here we design a quiz test containing 50 MCQs on biochemistry. It will help you to prepare for competitive exams or interviews. Related:
Q. Do we need to initiate an OOS investigation if OOS results are found during API Method Transfer? Ans: Yes, if it happens at the originating lab. If it happens at the receiving lab, handle it through a lab incident or deviation to identify the root cause as per in-house SOP; no OOS is needed….
Q. What is computer system validation and why is it important in regulated industries? Computer system validation is the process of ensuring that a computer system meets the requirements of a specific regulatory standard. It is important in regulated industries because it helps ensure data integrity, product quality, and patient safety. Q. What regulatory requirements…
Pharmaceutical Supply Chain Management is a core part of pharmaceutical industry. They maintain the inventory up-to-date as per company requirements. A list of common interview questions and answers on supply chain management are mentioned below: Q. What is supply chain planning? Supply chain planning involves the processes and strategies used to optimize the delivery of…
Nowadays project management is a crucial sector in pharma industries. A project manager can guide a project right way and can track all the activities from initiation to closing of the project. Here we mention few common interview questions for the candidates who are interested to get project manager role in a pharma industry: Q….
Q. What do you mean by Active Ingredient? Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, or to affect the structure or any function of the body of man or other animal, 21 CFR 210.3 (b)(7). Q. What do you mean by Inactive ingredient (Excipient)?…
Pharmaceutical marketing team play a vital role in the pharma sector. They need to identify new business opportunity for driving the company from frontline. Here we list out few common interview questions and answers for pharmaceutical marketing job seekers to take a preparation. Q. What are the sources of drug information? Th ere are three…
Q. What do you mean by pre-formulation study? A study conducted before the formulation development begins and aim to gather primary information about the physical and chemical properties of the drug substance, drug product and reference product (RLD). Q. What do you mean by RLD? RLD stands for Reference Listed Drug approved by regulatory authority…