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Pharmaceutical Guidelines

Jan 15, 2017

Principle of Bacterial Endotoxin Test (BET)

The Bacterial Endotoxins Test is an invitro test that is usually carried out when one is keen to identify whether there are endotoxins. Endotoxins are also commonly known as pyrogens and they are mainly produced by gram negative bacteria. The principle of Bacterial Endotoxin Test makes it the most sensitive test that one can use to detect and quantify endotoxins, toxins that are famously known for causing fever in humans. Pharmaceutical products can be contaminated during purification, production or packaging stages, and the Bacterial Endotoxin Test is used to confirm that the products are not contaminated before they are administered for use in humans.
Jan 8, 2017

Concept of GXP in Pharmaceuticals

One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GXP is a collection of regulations that aim to resolve this matter in a systematic and wholesome manner. The concept of GXP in Pharmaceuticals was established by the United States Food and Drug Administration.The term itself encircles many different regulations in many different fields. The G stands for "Good" and the P stands for "Practice". The 'X' in the middle is a variable that can be substituted with any word that appropriately completes the acronym. For example, 'X' is replaced by 'M' to make it GMP which represents 'Good Manufacturing Practice'. GXP extends to many regulated industries such as cosmetics and food as well besides pharmaceuticals. Regulators for GXP are spread out throughout the World. Some of the popular regulators include FDA in the US, TGA in Australia and HS-SC in Canada.
Jan 1, 2017

Different Types of Titrations

Titrimetry, or in more general terms titration is a process which is carried out to analyze an unknown compound in order to determine the concentrations of various substances present in it. It is a well-known method used in laboratories for the sole purpose of quantitative and qualitative estimation of a particular chemical substance.
Dec 25, 2016

Epoxy Flooring and Its Benefits in Pharmaceuticals

The floor coatings of companies manufacturing medicinal drugs should manage to resist most oils, acids, and solvents. Also, the coating must be resistant to abrasion and impact since the plant’s floors could easily be exposed to heavy traffic from hefty tools and machinery. A type of floor coating that can surely offer durable and hard wearing solutions is the epoxy flooring. This type of floor coating can be applied over concrete floors to ensure a high performance as well as an attractive surface.
Dec 18, 2016

Difference between Fumigation and Fogging

To keep the controlled area from being contaminated in pharmaceuticals, two processes namely fumigation and fogging are used. Both the processes are used for the same purpose, but the difference between fumigation and fogging in pharmaceuticals is great. Moreover, fumigation is banned in few pharmaceuticals because of its negative effects while fogging is a safer option than the former.
Dec 11, 2016

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 for preparation. FDA is doing this because they want to develop a quality culture in pharmaceutical firms instead of a culture where quality is maintained before inspection.
Dec 4, 2016

Process Analytical Technology (PAT) in Pharmaceuticals

Process Analytical Technology is a system for designing, analyzing and controlling manufacturing processes through timely measurement during processing. With the goal of ensuring final product quality, it analyzes raw and in- process materials. The PAT is now being deployed in the pharmaceutical industry, where it is seen as a technology that can help companies to improve their conformity with manufacturing regulations. The emphasis in PAT is in the manufacturing process to increase the basic premise of the current drug quality system because quality can’t be tested into products, it should be built-in or should be by design.
Nov 27, 2016

Difference between Sterilization and Depyrogenation

To understand the difference between sterilization and depyrogenation, we have to discus both of them separately, in length to really know the line that separates them. Basically, sterilization is a method that can remove, kill and deactivate microorganisms on a surface like for example the stainless equipments, media etc. On the other hand, due to the high variability of their molecular weight, pyrogens are hard to sterilize. Depyrogenation refers to removing pyrogen from a solution or pharmaceutical vials. Endotoxins are bacterial byproducts that become pyrogenic (active) when released to the blood stream.
Nov 20, 2016

Determination of Hot and Cold Spot in Stability Chamber

Everything from pharmaceutical products to personal consumer products are tested in stability chambers to get an accurate reading of conditions to be stored in. This process is absolutely foremost to be considered for FDA approval, the FDA requires proper testing and evidence of tests performed to monitor how products react, taking temperature, humidity and various other conditions into account.
Nov 14, 2016

Quality by Design (QbD) in Pharmaceuticals

The term quality means the appropriateness for the intended use. In the field of pharmacy, quality refers to the state of being free from any contamination and ability to treat the disease intended for. The Quality of the pharmaceutical commodity can be assessed by in vivo or in vitro execution tests. Quality by plan guarantees in vitro item execution and In vitro item execution gives affirmation of in vivo item execution. "Henceforth Quality by outline identify with Product Performance".
Nov 6, 2016

Forced Degradation Study in Pharmaceutical Stability

Forced degradation is also known as stress testing and drug is degraded forcefully by applying artificial methods. It is a useful tool to predict the stability of any Active Pharmaceutical Ingredient (API) or formulation product. It helps to know about the impurities developed during the storage of drug products in various environmental conditions.
Oct 30, 2016

Quality Management System (QMS)

Organizations engaged in the distribution as well as the storage of materials along with products should monitor, establish, maintain and implement the aspects of quality management system that allows the delivery of resources, product and services, and materials with the requisite quality and safety.
Oct 23, 2016

Mean Kinetic Temperature (MKT) in Stability Studies

Mean Kinetic Temperature is a useful tool used in pharmaceutical stability studies. It helps to calculate the degradation of stability sample.
Oct 16, 2016

Importance and Method of De-gassing in Purified Water System

In pharmaceutical industries bore-well is the principle source of the raw water. Raw water is purified by water purification systems to use in pharmaceutical manufacturing. Cation and anion beds are used to remove the hardness of raw water.
Oct 9, 2016

Importance of Validation in Pharmaceuticals

Validation is a documented evidence of the consistency of any process or system. It was firstly appeared in 1978 in United States by the Food and Drug Administration (FDA) to investigate the failure of the product in sterility and now it is very common concept in the pharmaceutical industries throughout the world.
Oct 2, 2016

Calibration Frequency of Instruments and Other Measuring Devices

Calibration of instruments and other measuring devices is done to verify its performance. It is comparison of the reading found from the instrument or measuring device and the known value or reference standard. The difference between the measured value and standard value helps to determine the instrument performance.