The United States Food and Drug Administration (FDA) defines a Warning Letter as “…a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be […]
Here we are providing the information that what are the precaution you need to be taken during giving any pharmacy registration and how to take relieving from medical shop. It is myself experience. Do’s Prepare an agreement that how many year (minimum 5 to maximum 10 year) you want to engage with medical shop (shop […]
Among the health care professionals, pharmacists are considered as major pillars in design, development and supply of quality medicines to the patients. The development of pharmaceuticals/formulations is an outcome of interplay between pharmaceutical and medicinal chemistry (especially synthetic and phytochemistry), pharmaceutics and pharmaceutical technologies, analytical techniques and quality assurance at each and every level. Along […]
Selection of Glass compatibility with drug product is major issue in Sterile Pharmaceutical practice. Physical and & Chemical stability is the major issue. Wrong selection of glass type caused breakages during Lyophilization, washing, DHS etc activity. “ As per 21CFR211.94 Drug product containers and closures: (a) Drug product containers and closures shall not be reactive, […]
Safety is our main aim. Don’t think life is a game. Be alert open your mind- Don’t be fool and act as blind. Use proper tool by keep your mind cool, Never being hurry and never being worry, Prepare & prevent instead of repair & repent. Remember!! Accident Big or Small- Let them avoid all. […]
1 Get the facility design right from the start 2 Validate processes 3 Write good procedures and follow them 4 Identify who does what 5 Keep good records 6 Train and develop staff 7 Practice good hygiene 8 Maintain facilities and equipment 9 Build quality into the whole product lifecycle 10 Perform self audits
Risk assessment is a systematic examination of a task, job or process that you carry out at work for the purpose of; Identifying the significant hazards that are present (a hazard is something that has the potential to cause someone harm or ill health). Now a day’s it’s a very popular approach in pharmaceutical industry, […]
Manufacture of sterile pharmaceutical preparations, four grades of clean areas are distinguished as follows: Grade A: The local zone for high-risk operations, e.g. filling and making aseptic connections. Normally such conditions are achieved by using a unidirectional airflow workstation. Unidirectional air flow systems should provide a homogeneous air speed of 0.36–0.54 m/s (guidance value) at […]
SMS service for awareness on cheaper drugs: Sep 1, 2012, 12.59PM IST, The writer has posted comments on this article PTI NEW DELHI: The Department of Pharmaceuticals in the Ministry of Chemicals and Fertilisers is planning to launch a SMS service providing information about affordable alternatives to medicines prescribed by doctors.The Short Message Service (SMS) […]
Interview questions mostly asked during technical round in Production : 01. Q. Which type of tablets are exempted from Disintegration testing? A. Chewable Tablets 02. Q.What are the common variables in the manufacturing of tablets?A.· Particle size of the drug substance· Bulk density of drug substance/excipients· Powder load in granulator· Amount & concentration of binder· […]
