A New Drug Application is submitted to the FDA when any company wants to bring a new drug in the market. The purpose of the submission of the NDA is to get approval for the marketing of the new drug in the US market. There are many benefits of submitting a new drug application for FDA approval, some ...

I. Introduction II. Organization and Personnel A. Responsibilities of the Quality Control Unit B. Personnel Qualifications C. Personnel Responsibilities D. Consultants III. Buildings and Facilities A. Design and Construction Features B. Lighting C. Ventilation, Air Filtration, Air Heating and Cooling D. ...

Chapter 1: Quality Management – Principles – Quality Assurance – Good Manufacturing Practice – Quality Control – Audits – Quality Evaluation Audits – Critical Procedures Chapter 2: Organisation and Personnel – Principles – Responsibilities of Key ...

Contamination is a very serious issue in pharmaceutical manufacturing especially in sterile manufacturing. It is important to control the contamination in the pharmaceutical manufacturing area to protect the product. There are many ways of contamination so there are different strategies to control it. ...

1. Meaning of a Drug Master File DMF stands for Drug Master File which is a voluntarily submission at the holder’s discretion to help the customers. 2. Drug Master Files’ Regulatory Basis It is not a necessity by law to submit DMF, on the other hand, it is submitted at the holder discretion. Upon ...

This is a list of International Organization for Standardization (ISO) standards. ISO 1–ISO 999 * ISO 1 Geometrical Product Specifications (GPS) — Standard reference temperature for geometrical product specification and verification * ISO 2 Textiles — Designation of the direction of twist in yarns ...

New Drug Application (NDA) are the documents about the product you want to manufacture and those are submitted to the government to detail the product and its usage. This document may take months to years to be approved, so it is important to submit the correct NDA for approval. What is NDA? If you ...

The URS includes all the requirements that the process or system must meet. Either developed by the user alone or with the help of the vendor with approval from Quality. The various requirements mentioned in this document include: – Automation Requirements such as alarms, interlocks, and process control – ...

ALCOA principle to maintain data integrity: The ALCOA stands for A Attributable : Date should clearly state who performed the action and when? Data should be imputable implies that all collected information must-have info on WHO collected the info, who acted, and once the action was performed. This ...