Compliance in the pharmaceuticals is key to success, not only because it is required by law, but because the pharmaceuticals industry is considered one that doesn't allow mistakes. That is, if you make a faulty cell phone, your customers will ultimately get angry at you, but nobody gets hurt. W…
Prevention of Microbial Contamination in Manufacturing
The quality and safety of pharmaceutical products should be a key concern to any manufacturer in order to take care of clients consuming the product as well as maintaining their brand name in the market. Therefore to prevent microbial contamination in pharmaceutical products, there are some key mea…
Reduce Validation Cost in Pharmaceuticals
The traditional validation process in the pharmaceutical industry is time-consuming and not very cost effective. There are various factors that can lead to increased costs and unnecessary delay in the validation. Some of these factors include inefficient analytical testing methods, an excessive num…
Requirements and Implementation of Continuous Training in Pharmaceuticals
Training is crucial in almost every field. In pharmaceutical industry it is of great importance as a slight difference in the composition of a drug can cause huge effects on a person or even cause death. It takes years of hard work to develop a drug formula. Getting the drug approved by FDA and oth…
Criteria for Selection of Clean Room Garments in Pharmaceuticals
A clean room in the pharmaceutical industry is a specialized place that has very limited contaminants such as air particulates and chemicals so as to ensure the quality of the products produced is not only achieved but also maintained. In order to achieve such a sterile environment, the products, a…
Planning and Execution of Internal Audits in Pharmaceuticals
In any type of audit, the first and most important part is making a plan. In order to make the execution of audit of pharmaceutical effective and efficient, a good audit plan is compulsory. Internal Audits can be a valuable tool for any company for information collection and assessment of daily per…
Requirements and Maintenance of HVAC System in Manufacturing Facilities
Installation of a working and well-maintained heating, ventilation, and air conditioning system (HVAC) is a fundamental requirement in any pharmaceutical facility that value quality, and conducive working environment. Many pharmaceutical and biopharmaceutical products fail due to the improper envir…
Difference between GC and HPLC Techniques
Gas Chromatography and the High Performance Liquid Chromatography are separation techniques used in obtaining specific eluents from an analyte basing on the compounds in the analyte distribution between the two phases (Mobile phase and Stationary phase). The mobile phase is the part in chromatograp…
C18 HPLC Columns and Their Properties
Standards and success of any pharmaceutical company is determined by how professional chemical analysis are being undertaken. Chromatography remains the most important technique for identifying and analyzing a wide variety of chemical samples within pharmaceutical industries. The technique does not…
Mechanism of Separation of Components by HPLC
HPLC stands for High Performance Liquid Chromatography. 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 through…
Difference between C8 and C18 Columns Used in HPLC System
High Performance Liquid Chromatography (HPLC) refers to a technique in analytical chemistry that is used to identify, separate and quantify each component in a mixture. C8 and C18 both refer to the alkyl chain of a bonded face of a column. They are both used in the high performance liquid chromatog…
Differences between HPLC and UPLC
Liquid chromatography is a technique that is utilized to separate any sample into its individual components. In this case, the chromatographic procedure involves a liquid as the moving phase. HPLC and UPLC stand for High Performance Liquid Chromatography and Ultra Performance Liquid Chromatography …
Karl Fischer Reagent and Its Reactions
You are given a sample with a trace amount of water and you need to determine the amount of water in the sample, what do you do? The method to use is the Karl Fischer (KF) moisture analysis. Karl Fischer method uses the Karl Fischer Reagents to determine the moisture content of a sample and it is a…
Electronic Batch Records in Pharmaceuticals
Traditionally, most pharmaceutical companies used hard copy records to keep production batch records commonly known as master production batch records. However, this documentation method has numerous shortcomings. In 1997, Electronic Batch records in Pharmaceuticals were accepted by FDA after EBR …
Validation of Clean Room Pass Boxes
A pass box which is also called a hatch is an equipment which is used to transfer pharmaceutical material from an area of lower cleanliness to an area of higher cleanliness and vise-versa. They, therefore, work as a barrier between areas with different levels of cleanliness.
Occupational Exposure Bands (OEBs) for Chemicals
Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. They are usually classified on th…
