Pharmaguideline

The two main types of air filters employed in biosafety cabinets, pharmaceutical manufacturing, electronic goods manufacturing, room air pur...

Data integrity is highly important in any industry, but especially so in the pharmaceutical industry where any data error could mean serious...

In pharmaceuticals, quality inspection involves a complete assessment and testing of medicinal products to ensure that they meet the require...

Most of the 483s and warning letters are issued because of common GMP errors. Below I have described common mistakes (and ways to avoid t...

Purified water is commonly used in the pharmaceutical industry, science laboratories, laser cutting and automotive use. Purified water finds...

One of the most pronounced ingredients in any pharmaceutical engineering is water. Water serves as a solvent and ingredient for formulation ...

Factory Acceptance Test (FAT) is done at the equipment manufacturing site of the vendor before the shipping. A proper FAT can help to min...

The goal of a barrier system is to segregate people from the product so that certain pharmaceuticals are not exposed to certain organisms a...

The main ingredient in most of the pharmaceutical products used by people is water. Given the ever-increasing concerns about the ingredie...

HVAC system provides a safe and controlled environment for pharmaceutical manufacturing because most of the pharmaceutical drugs are temp...

Cleaning Method validation is the process in which documentation of how the cleaning process of manufacturing equipment is done. Most times ...

It is being difficult to handle an FDA audit these days because a lot of warning letters are being issued to different pharmaceutical comp...

A clean room in the pharmaceutical industry is a specialized place that has very limited contaminants such as air particulates and chemicals...

Water treatment, storage and distribution system for preparation and distribution of purified water should have the properties to control ...

Any equipment that is being intended to be used in producing various products has to meet certain specifications before it is delivered to a...

Temperature and humidity are important factors in the stability of the pharmaceutical ingredients. Temperature sensitive materials can d...

Good Automated Manufacturing Practice denoted as GAMP, are guidelines provided for both users of automated pharmaceutical products and manu...

Media fill test assures the sterility of the sterile manufacturing process . When any media fill test fails, it shows the contamination ...

It is necessary to use recovery factor for accurate results in cleaning validation of pharmaceutical manufacturing equipment. Recovery f...

The Cleaning validation is performed to demonstrate the effectiveness of procedures for cleaning to remove the residue of the previous pr...

The traditional pharmaceutical validation process in the pharmaceutical industry is time-consuming and not very cost effective. There are va...

FDA has the mandate of ensuring the safety of the public by assuring the safety of drugs and medical devices among others. To this end, FDA...

Pharmaceutical companies are an important part of the medical field. They play a significant role for everyone involved, such as the produce...

Quality System in Pharmaceuticals or other words quality assurance is a dynamic process of understanding the regulations in this industry. T...

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 ca...

Maintenance of pharmaceutical clean area has its importance in sterile manufacturing. Sterility of the sterile products is the most imp...

Root cause analysis is done to determine the main cause of the error or problem caused during the process. The root cause for the out of ...

The term ALCOA is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. ALCOA was then expanded to ALC...

High Performance Liquid Chromatography system (HPLC) refers to a technique in analytical chemistry that is used to identify, separate and qu...

Analytical method development is considered as a critical process in pharmaceuticals. Availability of the different types of columns, opera...