Sterility is a critical test in sterile pharmaceutical manufacturing. there are a lot of chances of errors in this test due to the requirement of highly aseptic conditions during the process. The analyst must be careful about the contamination during the handling of the sample and sterile equipment…
Possible Causes of Out of Specification
Out of specification is the deviation of the product from the pre-determined specification. It means when a product is unable to meet the predefined limits for that particular product. There are various possibilities that may be responsible for these deviations.
How to Eliminate Microbial Contamination from Classified Area
We are receiving a lot of queries from pharmaceutical professionals that they have a lot of contamination in the classified areas. Contamination exceeds grade limits and they have tried everything but unable to get rid of it. Here we shall discuss the effective ways to remove the contamination from…
How to Prepare for a FDA Inspection
Facing FDA inspection is being critical day by day because FDA is inspecting pharmaceutical units at very short notice period. This makes it critical because of having a short period of preparation. FDA is doing this because they want to develop a quality culture in pharmaceutical firms instead of…
Top 5 Tips for a FDA Inspection
It is being difficult to handle an FDA audit these days because a lot of warning letters are being issued to different pharmaceutical companies. Following are some tips to handle the FDA inspection properly.
5 Most Common 483s in FDA Inspections
Most of 483 observations in FDA inspections are repeated frequently in different pharmaceutical companies. The same observation is reported many times in a year but companies are not focusing on the elimination of these issues. These common issues/ mistakes could be easily eliminated before any ins…
Mechanism of Separation of Components by HPLC
HPLC stands for High Performance Liquid Chromatography system. This is an analytical chemistry technique that is used to separate, quantify and identify every component that is in a mixture. The technique depends on pumps to push some constrain liquid solvent which contains a mixture of the sample …
Why Data Integrity is More Important Than Ever?
Data integrity is an old concept that was first given in 1938 in Federal Food, Drug, and Cosmetic (FDC) Act but now in the digital age, it has become even more important. Every employee working in pharmaceutical industries must aware of the significance of data integrity including analyst, pharmaci…
Problems Associated with Pharmaceutical Cleanroom Areas
Pharmaceutical cleanroom areas are used to protect pharmaceutical products from pollutants that cause undesired contamination in pharmaceutical products to be produced. These contaminants can occur due to several reasons. Human being plays a significant role in producing this contamination through …
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 communicat…
Critical Mistakes during Root Cause Investigation
Root cause analysis is a very frequently used tool in pharmaceutical industries to identify the cause of any deviation and determine the CAPA for GMP violations. Improper root cause investigation is commonly found in observations of regulatory inspections.
Fault Tree Analysis for Investigation
The fault tree is an investigation tool to identify and resolve the defects in any system or process. It is also helpful to find the root cause of any event. An organization or company may have more than one fault trees based on their defects, errors or problems.
Regulatory Expectations for Cleaning Validation
Cleaning validation is an integral part of the pharmaceutical manufacturing process. A piece of equipment itself can contaminate the product if it is not cleaned properly. Improperly cleaned manufacturing equipment is a major source of cross-contamination. Regulatory agencies are more concerned abo…
Number of Temperature Probes for Autoclave Validation
Autoclave validation has a very important role in pharmaceutical sterile manufacturing and also in the microbiology laboratory. Whole sterile manufacturing process depends on proper sterilization of equipments used in manufacturing.
Less than 1 CFU/Plate in ISO 5 Class - How is it Possible?
There are different cleanliness classes in pharmaceuticals. Class 100 or ISO 5 is the highest cleanliness class found on pharmaceutical industries and used in LAF and sterile filling area. this area is monitored for viable and non-viable particle counts. Some people have confusions about the limits…
