Sampling plays a major role in achieving the accurate results of analysis. Sampling plan and procedure must be defined in validation protocols and training should be provided to the concerned staff before the validation activity starts.
Jul 17, 2016
Master formula record (MFR) is a master document for any pharmaceutical product. It contains all information about the manufacturing process for the product. MFR is prepared by the research and development team of the company and all other documents like BMR and BPR are prepared using MFR by the manufacturing units.
Jul 10, 2016
Jul 3, 2016
Maintenance of clean room area is very expensive. It is a common question that everyone wants to ask that can we switch off our HVAC systems in night to save the power consumption?
Jun 26, 2016
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.