The purpose of this article is to supplement the guidance provided in this document with information on products regulated by CBER or CDER that are subject to aseptic processing from early in the manufacturing process, or that require aseptic processing through the entire manu...

Lyophilization is a process by which water is removed from biological material for long term stability. More specifically, Lyophilization occurs when a biological material is frozen and subsequently the pressure around the material is lowered below the triple point of the subs...

Care should be taken in the performance of the sterility test to preclude any activity that allows for possible sample contamination. When microbial growth is observed, the lot should be considered to be non-sterile. It is inappropriate to attribute a positive result to labora...

Wastewater treatment is closely related to the standards and/or expectations set for the effluent quality. Wastewater treatment processes are designed to achieve improvements in the quality of the wastewater. The various treatment processes may reduce: Suspended solids (physic...

High performance liquid chromatography is a powerful tool in analysis. This page looks at how it is carried out and shows how it uses the same principles as in thin layer chromatography and column chromatography. Introduction High performance liquid chromatography is basically...

An essential element in ensuring aseptic conditions is the maintenance of HEPA filter integrity. Integrity testing should be performed at installation to detect leaks around the sealing gaskets, through the frames or through various points on the filter media. Thereafter, inte...

There are some significant concerns as to the need for Growth Promotion testing of standard media. It can be argued that since all preparation conditions are under control and the physical parameters of the finished media are checked, there is little additional information gat...

Food-grade lubricants must perform the same technical functions as any other lubricant: provide protection against wear, friction, corrosion and oxidation, dissipate heat and transfer power, be compatible with rubber and other sealing materials, as well as provide a sealing ef...

Drinking Water - It is not covered by a compendial monograph but must comply with the quality attributes comparable regulations of the European Union or Japan. It may be derived from a variety of sources, including a public water utility, a private water supply (e.g., a well),...

As with all powerful ideas, 3-sigma is simple, yet difficult to get your head around. Although there is no short explanation, here's the shortest answer I can provide. First of all, 3-sigma isn't the stuff of slogans and marketing literature. There are no black-belts in 3-Sigm...

Facts About Current Good Manufacturing Practices (cGMPs) Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. M...

A critical area is one in which the sterilized drug product, containers, and closures are exposed to environmental conditions designed to preserve sterility. Activities conducted in this area include manipulations (e.g., aseptic connections, sterile ingredient additions) of st...

CAPA is a fundamental management tool that should be used in every quality system. Corrective ActionsA corrective action is a term that encompasses the process of reacting to product problems, customer complaints or other nonconformities and fixing them. The process includes:1...

Chlorine is one of the most widely used disinfectants. It is very applicable and very effective for the deactivation of pathogenic microorganisms. Chlorine can be easily applied, measured and controlled. It is fairly persistent and relatively cheap. Chlorine has been used for...

Blow-fill-seal (BFS) technology is an automated process by which containers are formed, filled, and sealed in a continuous operation. This manufacturing technology includes economies in container-closure processing and reduced human intervention, and is often used for filling...

Product quality review is an annual evaluation of a pharmaceutical preparation, which looks back at production and quality control data to assess changes, trends and weaknesses.In other words it is a structured procedure in which all information, changes and dependencies that...