A well developed cleaning method is a primary requirement of the cleaning validation. Cleaning procedure should be developed before starting the cleaning validation. Following things should be considered during development of good cleaning procedure.
Jun 19, 2016
Sufficient light is necessary at work place to get better work output. Less lighting in working area can result errors in different ways. None should experience eye-strain during his work.
Jun 12, 2016
483 is a FDA form that is issued to report the GMP inspection observation by FDA officials. It contains all objectionable activities found by the FDA inspector during the inspection of a manufacturing facility.
Jun 5, 2016
May 29, 2016
Human errors have critical effects on pharmaceutical product quality. About 80% of the product quality issues occur due to the human errors. Human errors are traced by the occurrence of the deviations in the process. Most of the root causes of deviations are human errors due to improper communication or failure to follow the written procedure.
May 22, 2016
May 15, 2016
May 9, 2016
Pressure differential is difference between atmospheric pressure between production area and its surroundings. It is measured in pascal using magnehelic pressure gauge.
May 2, 2016
Apr 25, 2016
The general function of an alarm is to warn about any critical condition as life threatening danger or any critical environmental condition like building fire alarm etc. But in pharmaceutical manufacturing facility the requirement of audible alarm in critical equipments has its great importance because the change in temperature can affect the pharmaceutical product quality or it can alter the analysis results.
Apr 17, 2016
A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and approval.
Apr 10, 2016
Proper execution of protocol is an important part of the validation process. Execution of validation protocol affects the validation results. There should be minimum deviations during the validation process.
Apr 3, 2016
Maintenance of sterile area is a critical task because air as well as the personnel working in the sterile classified area are the main source of the contamination. Following are the some good manufacturing practice points those shall help in maintenance of sterile area.
Mar 28, 2016
ISO 14644 Part 1 is a useful guideline to maintain the good manufacturing practices in sterile pharmaceutical manufacturing as well as the oral dosage forms. This document provides the standards for the clean room classification. Revision of the guidance was started since 2007 and its drafts are already published in 2011, 2012, 2014 and 2015 but none was finalized and 1999 version was applicable and expecting a new version.
Mar 13, 2016
Depyrogenation is the removal of pyrogen (endotoxins) from the pharmaceutical materials or equipments. Endotoxins are the lipopolysaccharides found in the cell walls of the gram negative bacteria. Pyrogen causes fever when enter in bloodstream.