The Pharma Journal

                                               The Pharmacist job in India is still not in mainstream even though its considered as one of the respectful job and highest paying job in world. The salary of a pharmacist depends on various reasons which are mentioned below. 1. The Pharmacist job evolves under tagline of experience. Of course, the students who just completed their graduation wouldn't get a high pay at the start. for a few example, many break stereotypes and bags a high package more than engineers in India. 2. The establishment of Pharma companies require more funds than establishing an engineer firm. The maintenance cost of Pharma companies are much higher than IT sector firms. for instance, an IT firm needs one time investment and minimal charges for maintenance. Where as the Pharma company has to spend on raw material,inspection,sterilization. The Pharma...

Pharmaceuticals and Medial Device Agency is the is the regulating Authority for Pharmaceuticals in Japan. This Agency came to force on 1/04/2014. The various registration Application are as follows: 1.Clinical Trial Notification for New drug development (IND). 2.New Drug Approval Application. 3.Generic Drug Approval Application. 4.Orphan Drug Application. 5.Priority review. 1. Clinical Trial Notification for New drug development (IND): Ø   This Application is important if the company intends to conduct clinical trial for a drug and to collect data for applying for manufacturing/marketing. Ø   The Clinical trial should be conducted as per Good Clinical Practice. Ø   If the Clinical trial is conducted for drugs with new APIs, Drugs with new route of administration, or if the drug is a new combination product, the clinical trial protocol has to be submitted. Ø   The review of application till takes 30 days after start of clinical trial. Ø   The ...

Introduction: The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.  It is the duty of the physician to promote and safeguard the health of the people. The physician’s knowledge and conscience are dedicated to the fulfillment of this duty.  The Declaration of Geneva of the World Medical Association binds the physician with the words, ‘‘The health of my patient will be my first consideration,’’ and the International Code of Medical Ethics declares that, ‘‘A physician shall act only in the patient’s interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient.’’ Medical progress is based on research which ultimately must rest in part on experiment...

 ICH Q9 guidelines are known as Quality Risk Management issued by International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. This guidelines gives description on how the Quality Risk Management can be applied to uphold the quality of medicines in Pharmaceutical Industry. This guideline also covers development, Manufacturing and Distribution including whole life cycle of medicinal products. Quality Risk Management can be defined as a systematic assessment of risks and a approach to control and communicate such risk to enhance Quality of product. Principle of Quality Risk Management: The principle includes Evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient and the level of effort, formality and documentation of the quality risk management process should be in correspondence with the level of risk. Process of Quality Risk Management: The Quality Risk Management f...