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What does Inspector Look for during FDA Inspection?

FDA inspections in pharmaceutical manufacturing units is being critical these days and it seems that it will be more critical in future because FDA is focusing more on product quality as well as its documentation.

Steps for HPLC Method Development

Analytical method development is considered as a critical process in pharmaceuticals. Availability of the different types of columns, operating parameters, mobile phase composition, diluent and pH values make it critical to develop an analytical method. A good analytical method should be simple, u…

10 Tips for HPLC Analysis In Pharmaceuticals

HPLC, also known as High-Performance Liquid Chromatography system, is one of the most crucial analytical methods in pharmaceuticals. The purpose of HPLC is the separation of each compound that make up a mixture.

It passes pressurized liquid solvent with the use of pumps which holds the sample mixtu…

Steps for HPLC Method Validation

In the pharmaceutical industry, validation is an essential part of quality control and quality assurance. Various regulatory authorities give particular emphasis on the validation of all the processes used in the industry. Validation is a formal and systematic way to demonstrate the suitability of …

FDA’s Top Data Integrity Issues Found During Inspections

Data integrity is the common issue that is found during the FDA inspections. When FDA finds any invalid or unreliable data during the inspection, it is considered by FDA that the quality of the products manufactured in such a manufacturing facility cannot be good. FDA issues warning letter when the…

Top 10 Tips for Sterility Test

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…

About the Author

Ankur Choudhary is experienced in pharmaceutical, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.

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