Skip to main content

Drug Master File

Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.
The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.

Source: Wikipedia

Labels:

Comments

Post a Comment

Popular posts from this blog

The scientific method is a systematic and logical approach to understanding the natural world through empirical observation, experimentation, and the formulation and testing of hypotheses and theories. The scientific method is a step-by-step approach in studying natural phenomena and establishing laws which govern these phenomena. Any scientific method involves the following general features. (i) Systematic observation (ii) Controlled experimentation (iii) Qualitative and quantitative reasoning (iv) Mathematical modeling (v) Prediction and verification or falsification of theories (i) Systematic observation: Scientific inquiry begins with careful and methodical observation of natural phenomena. This involves gathering data through various means, such as direct observation, measurement, or using specialized instruments, to collect qualitative and quantitative information about the phenomenon under study. (ii) Controlled experimentation: After making observations, scientists design and c...
Post a Comment
Read more

The duty of every citizen of India to develop scientific temper

According to part IV Article 51A (h) of Indian Constitution “It shall be the duty of every citizen of India to develop scientific temper, humanism and spirit of inquiry and reform’’. This is the aim of our Science Education. The directive principle mentioned in Article 51A(h) of the Indian Constitution, which states that " It shall be the duty of every citizen of India to develop scientific temper, humanism and spirit of inquiry and reform ," is indeed a guiding principle for the aim of science education in India. This constitutional provision highlights the importance of inculcating certain values and attitudes among the citizens of India, which are crucial for the progress and development of the nation. Let's break down the key elements of this directive and how they relate to the aims of science education: 1. Develop scientific temper:    - Science education should foster a scientific temper, which involves cultivating a rational, objective, and evidence-based approac...
Post a Comment
Read more