Pharmacovigilance Pharmacovigilance: Pharmacovigilance WHO defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of marketed medicines or those under trial. The drug regulatory agencies have the responsibility of having a well-established pharmacovigilance system to monitor adverse reactions of drugs, during the drug development phase and later…
Levels of Cleaning in Cleaning Validation The manufacturing process of an Active Pharmaceutical Ingredient (API) typically consists of various chemical reactions and purification steps followed by physical changes. In general, early steps undergo further processing and purification so potential carryover of the previous product would be removed. The level of cleaning required to ensure that…
EU and US GMP/GDP: Similarities and Differences Reference: McGee Pharma International-Nov. 2016 Thank you for visit and for more pharma updates click here – https://pharmaguidances.com
Procedure for operation of Autotitrator (METTLER TOLEDO). Quality assurance OBJECTIVE To lay down the procedure for operation of AUTO TITRATOR (METTLER TOLEDO DL50) SCOPE This procedure is applicable to Autotitrator (METTLER TOLEDO DL50). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘…
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USFDA Generic Drugs: Questions & Answers What are generic drugs? A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the…
PROCEDURE FOR OPERATION OF HUMIDITY CONTROL OVEN (NEWTRONIC). Quality assurance OBJECTIVE To lay down the procedure for operation of Humidity control oven. Model : NEC 228R 10S SCOPE This SOP shall be applicable for the operation of Newtronic make Humidity control oven (30°C/65%RH) &. (40°C/75%RH) RESPONSIBILITY QA Officer / Executive ACCOUNTABILITY Assistant Manager Quality Assurance…
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USFDA – INTRODUCTION TO DRUG REGULATION Basic Mission Safety Efficacy Drugs Medical Devices Truthful Labeling Adulteration Misbranding FDA’s Structure and Organization The Commissioner President Appoints, Senate Confirms 4th Tier in HHS Not an Independent Agency Insulation From Politics (Old Days) Few Political Appointees Scientific Basis of Its Decisions Visibility Protects It From Presidential Pressure Does…
