Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System

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  • First autoimmun antibody diagnostic test for type 1 diabetes.

    ELISA Immunoassay test in detection of ZnT8Ab antibodies (zinc transporter 8 autoantibody) for diagnosis of Type 1 Diabetes. Type 1 diabetes is a form of diabetes which is one of very severe form of diabetes, wherein patients body do not produce insulin, or if at all it do is in very low amount. Insulin is…

  • Monoclonal Antibodies found to be reducing occurrence of migraine

    There is very little treatment options available for migraine and often those are not so effective in all patients unlike like other disease treatment involves lot of change overs in medications. A protein called calcitonin gene–related peptide (CGRP)is responsible for migraine. Hence to prevent the occurrence of migrane monoclonal antibodies which target this peptide was…

  • Validation in Pharmaceutical Industry Types of Pharma Validation

    Pharmaceutical validation In pharmaceutical manufacturing industryPharma Validation regulatory requirements.Validation in Pharma Industry is very important part of Pharmaceutical Quality Management System which in turn constitute quality assurance systems and intern Good manufacturing Practice guidelines. US FDA have given special emphasis on validation and it is prim requirement of US FDA pre-qualification, as well as all…

  • Pharmaceutical Area classification with respect to filters used as per WHO guidelines

    Pharmaceutical Area classification with respect to filters used as per WHO guidelines WHO gmp guidelines describes area in a pharmaceutical Manufacturing facility, as Level 1 level 2 and level 3 areas. Level 1 Area is a place where there is no possibility of contamination of product. Level 2 Area is an area where the raw…

  • New Options for HIV positive patients treatment will be available soon for daily dose of ART in HIV positive patients treatment

    Treatment of HIV positive patients requires daily dose of ART (Antiretroviral Therapy) medicines which are a combination of many anti-retroviral drugs combined together. Combination ART drugs prescribed to HIV positive patients to keep their viral load under control and are very effective in providing protection against HIV to patients. Daily dose of antiretroviral medicines also has some…

  • Betalactam Antibiotics require separate manufacturing area in pharmaceutical manufacturing company

    Why Betalactam Antibiotics require a separate manufacturing aria in a pharmaceutical manufacturing company?Chemistry behind the allergic reactions and mode of action of betalactum antibiotics: Answer:To avoid cross contamination of other products with betalactam antibiotics because A.The betalactum antibiotics may cause anaphylactic shock and anaphylaxis or may cause life threatening allergic reactions. B.The betalactum antibiotics molecules…

  • Automatic Insulin Pump that work in conjugation with blood glucose level sensor for children above 7 years age

    Type 1 Diabetes patients are required to take Insulin through regular injections in hypodermic Insulin syringes since type 1 diabetes patients body do not produce or produce insufficient amount of Insulin hence blood glucose level remains higher,  therefore type 1 diabetes patients are required to take dose of insulin through injections in daily repeated dosages.…

  • Sterilization Various methods of Sterilization Pharma

    Sterilization Various methods of Sterilization in Pharmaceutical manufacturingSterilization is a process of rendering an object or articles or substance free from all viable microorganisms, (bacteria , fungi , virus) here term viable is used because there might not be a living organism present after sterilization but its spores might germinate and give raise to microbial…

  • USFDA Guidelines quality audits 21 CFR Sec.820.22 Medical devises

     USFDA in its guidelines on Quality System, it has mentioned guidelines regulations, means it’s mandatory for pharmaceutical manufacturing units to follow the Guidelines. US FDA in its guidelines on Quality audists mention that Pharma Manufacturer must have a Procedure for quality audits, these must ensure and establish that Quality systems are followed and are in…

  • What is FAT SAT for Pharmaceutical

    What is FAT SAT for Pharmaceutical Manufacturing Equipment, machinery. Equipments in Pharmaceutical Manufacturing are required to of very good quality and Good Standards, by GMP guidelines, FDA regulations. Pharma Equipment’s Machineries are required to produce accurate results throughout the life span or predefined usage life span of that equipment for which it is going to…

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