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Pharmaceutical Guidelines


Jun 26, 2016

Tips to Develop Equipment Cleaning Procedure


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

Lux and Light Intensity for Pharmaceutical Areas


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

4 Tips to Reduce 483 Observations


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

Is Fungal Count Acceptable in Pharmaceutical Classified Area?


Classified area is monitored for viable and non-viable particles in pharmaceutical manufacturing. Fungus and bacteria both are found in the environment. Both are determined by the air sampling using the growth medium by settle plate and active air sampling methods.
May 29, 2016

6 Ways to Reduce Human Errors in Pharmaceuticals


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

Role and Calculation of Air Changes per Hour in Clean Room Area


Air changes in pharmaceutical clean room play an important role in maintenance of HVAC clean room quality. Air changes per hour are the number of total replacements of any room’s air in one hour.

May 15, 2016

Validation of Fumigation in Cleanroom Area


Fumigation is the process to disinfect the sterile manufacturing and microbiology testing area. Generally fumigation is not required when AHU runs continuously but when the microbial load increases in the controlled area it is controlled and minimized by fumigation of the area.
May 9, 2016

Importance and Maintenance of Pressure Differential in Manufacturing Area


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

Terminal Sterilization of Sterile Pharmaceutical Preparations


Sterile pharmaceutical products, large volume parenterals and small volume parenterals are sterilized after the packing of the final products is known as terminal sterilization. Process is important to assure the sterility of the product.
Apr 25, 2016

Requirement of Alarm System in Critical Equipments


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

How to Write a Validation Protocol?


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

How Effectively Execute a Validation Protocol?


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

GMP for Sterile Pharmaceutical Manufacturing


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

New Changes in ISO 14644-1:Classification of Air Cleanliness


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 in Injection Manufacturing


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.
Mar 6, 2016

Containers for Pharmaceutical Packaging


Plastics in packaging have proved to be useful for the ease with which they are formed, high quality and the freedom to design. For pharmaceutical products they are primarily made of polymers one of them being polyethylene.