Paracetamol and It Mechanisms of action Acetaminophen is an analgesic drug used alone or in combination with opioids for pain management, and as an antipyretic agent. Acetaminophen (paracetamol), is also used for its antipyretic effects, helping to reduce fever. This drug was initially approved by the U.S. FDA in 1951 and is available in a … Read more
Ceftriaxone injection CEFTRIAXONE is a cephalosporin antibiotic and Ceftriaxone injection is used to treat certain infections caused by bacteria such as gonorrhea (a sexually transmitted disease), pelvic inflammatory disease (infection of the female reproductive organs that may cause infertility), meningitis (infection of the membranes that surround the brain and spinal cord), and infections of the … Read more
Fluconazole Tablet Fluconazole is an antifungal medicine that is used to treat infections caused by fungus, which can invade any part of the body including the mouth, throat, esophagus, lungs, bladder, genital area, and the blood. Fluconazole is also used to prevent fungal infection in people who have a weak immune system caused by cancer treatment, … Read more
Manufacture of the finished Dosage Form – QbD: New EMA Guideline The European Medicines Agency (EMA) published its new guideline on Manufacture of the finished dosage form on August 14, 2017. The guideline replaces the “Note for Guidance on Manufacture of the Finished Dosage Form” (dated April 1996) and will enter into effect on February 14, 2018. … Read more
Cephalosporins Drugs Cephalosporins are beta-lactam antimicrobials used to manage a wide range of infections from gram-positive and gram-negative bacteria. The five generations of cephalosporins are useful against skin infection, resistant bacteria, meningitis, and other infections. This activity describes the indications, contraindication, and possible adverse effects of cephalosporins and will highlight the mechanism of action, adverse … Read more
SOP for QMS Tools Document Management –Review batch records, stability reports, validation reports, and associated documents required to comply with respective regulatory country GMP. Site Deviations – initiation, investigation, review, closeout, and maintenance for internal and external issues. Change Controls – initiation, review, closeout, and maintenance of all internal and external change controls. CAPA Management – manages … Read more
VALIDATION OF FREEZE DRYER “In freeze-drying, water is removed from the frozen state by sublimation, i.e., direct change of water from solid into vapor without conversion to a liquid phase”. Used for drying of a no. of products. Especially, Blood plasma and its fractionated products. Bacterial and viral cultures. Human tissues. Antibiotics and plant extracts. … Read more
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Retesting of Primary Packing Material (PPM) Objective: To lay down the procedure for retesting of primary packaging material (PPM). Scope: This SOP is applicable for retesting of primary packaging material in Quality control Responsibility: Chemist or above of QC Department for retesting of PPM. Officer or above of Warehouse Department for giving request for retesting … Read more
SOP on Intermediate and finished product Analysis and Approval To lay down the procedure for testing Intermediate samples and finished product. Procedure: Quality Assurance personnel shall collect the sample of finished and intermediate products and affix the “sample for analysis” label along with a Sample Intimation Slip filled with all details. The finished product shall … Read more