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Top 15 Reasons for receiving Form 483 observation in Pharmaceutical Companies A FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgement may constitute violations of Food Drug and Cosmetic Act and Related Acts. Folowing are top reasons for issuance of 483 FORM-   Scientifically Sound Laboratory Controls: Laboratory controls do not includes the establisment of scientifically sound and appropriate specification, standards, sampling plans and test procedure designed to assure that components, drug product containers, closures and in-process materials. Calibration/Inspection/Checking Not Done: Routine calibration, inspection, checking of automatic mechanical or electronic equipment is not performed according to a written program designed to assure proper performance. Cleaning /Sanitizing/Maintenance: Equipment and utensils are not Cleaned, Maintained, and Sanitized...

Temperature Mapping: Basic Requirement for Storage Area  Why Temperature Mapping   Storage areas need to be environmentally mapped to protect product quality and customer safety A comprehensive temperature mapping study will ensure that storage area is accurately monitored, properly maintained and in compliance with all the applicable regulations To Demonstrate by way of documented evidence that the chosen storage area is suitable for the storage of temperature sensitive medicinal products A mapping exercise of proposed storage area will ensure that the company will understand their storage area and identify any potential areas therein that may be unsuitable to storage medicines . A mapping exercise will also inform as to where permanent thermometers should be located.  What regulations and requirement must you comply with Before beginning to temperature mapping plan ensure that following requirements and constraints Calibration: T he ...