The traditional pharmaceutical 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 number of approvals and personnel required to validate documents, repetition and rework ..read more

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 officials occasionally visit manufacturing establishments for the purpose of carrying out an inspection to find out whether or not the establishment is in compliance ..read more

Pharmaceutical companies are an important part of the medical field. They play a significant role for everyone involved, such as the producer, the doctor who prescribes and the consumer who is the patient. The pharmaceutical industry has been in existence for several years now and is considered to be a key industry in the medical field ..read more

Quality System in Pharmaceuticals or other words quality assurance is a dynamic process of understanding the regulations in this industry. The drugs that are taken to the consumers need to be safe and not cause long term effects on the one taking them ..read more

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 ..read more

Maintenance of pharmaceutical clean area has its importance in sterile manufacturing. Sterility of the sterile products is the most important factor for the product quality and it can be achieved only by the proper maintenance of the manufacturing area ..read more

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 specification, deviations during manufacturing and market complaints must be determined. Different methods are used for root cause analysis in pharmaceuticals ..read more

High Performance Liquid Chromatography system (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 chromatography system. The two columns have some similarities, but they are also different in some way. Some of the differences between C18 and C8 are discussed here ..read more

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, used column, mobile phase and buffer should be common. It can be done easily step by step ..read more

Any equipment that is being intended to be used in producing various products has to meet certain specifications before it is delivered to a purchaser and installed. The equipment has to undergo what is called the Factory Acceptance Test (FAT) so as to ensure its proven quality and compliance. These tests play a vital role in ensuring guaranteed quality product ..read more