Steps for Getting CE Marking

DMF (Drug Master file) word is common to all in pharmaceutical field. This phenomena of DMF is origin of US FDA. DMF’s are submissions to US FDA which contains, confidential detailed information about facilities, processes, material used in manufacturing, processing, packaging and storing of human drug products. Advantage of DMF process is, Allow parties to use as reference material without disclosing confidential material content. They are not required by statue organization FDA neither approves or disapproves, FDA uses as review material in the application submissions of NDA’s, ANDA’s, IND’s, and BLAs. DMF is systematic structured document and its structure is guide for people who prepares and submits the same. Various information is available of web pages for, List of DMF’s, Types of DMFs, Submission resources, Templates and related information. US FDA is also preparing FAQ also on DMF. Contact email is dmfquestion@fds.hhs.gov Physical media submission is only accepted if volume is...

Alcohol does not need explanation but drug needs clarification in our subject what we are talking of drugs are nothing but prohibitive drugs used for so called mental enjoyment which is nothing but abuse. These people if drive on the road can be dangerous to other people and they can injure or kill others on road under the influence of alcohol or drugs. There are some other prescribed Drunk (Alcohol influence) driving or driving under influence (DUI) of drug is a criminal offence in India and several countries. There are various other terms like DUI. Driving while intoxicated (DWI), Operating while intoxicated (OWI). There are age limit for drunk driving between 18-25 years by different states but even alcohol limits are prescribed in blood (30 mg per 100 ml) anything beyond is treated as DUI case. Some states have totally banned alcohol while driving. The same also applies to drug so any person under influence of drug to such an extent that he/she is incapable of exercising any co...

  This is especially important subject in medical device world. Understand strategic transition, one needs to go in detail as what is MDD with respect to MDR, why transition? And what transition? MDD was labelled as directive, has quite relevant content but was not sufficient in view of rapidly changing technology which could deliver much advanced medical devices but also could have risk if it were regulated just by MDD. Objective of new MDR in broad category was to bring, improved consistency, better traceability, and transparency in regulatory process. Post market performance became particularly important aspect to judge newly designed advanced medical devices with modern technology. It is especially important to note that MDR is regulation as ‘R’ of MDR stands for regulation and it is must to adopt. New deadline for MDR compliance was 26 th May 2021. Now it is on and all those who are doing business of medical device in Europe has to see its compliance or else there will be...

  Validation has become very common word for those who are associated with pharmaceutical industry and now it has been adopted under main quality system and become one of the regulatory requirements. There are several challenges in pharmaceutical processes, validation is one of that. This is merely due to its scope and complexity. Mere testing of product, even doing several times and in detail does not provide assurance batch after batch and variations are likely. To ensure the variation within narrow range, control on the process is very essential and to know what to control also sometime emerges from processvalidation data. So let us start with official definition of process validation by FDA, “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product” The three-line definition states a lot because it starts from process desi...