Requalification, also known as ongoing performance qualification, is when the initial testing of a clean room is repeated to ensure that it continues to meet the same requirements as the facility ages. Water is a vital component in the pharmaceutical industry’s manufacturing process. Purified ...

The suitable packaging, labeling, and storage of all dosage forms are essential for product stability and safe use. The following are some main properties of packaging: – Packed content should be enclosed within the packaging material. – Flavor of the packed content should be intact. – It should ...

There are four main types of pas boxes used in pharma Clean Room. 1. Dynamic Passbox, (known as the active passbox). – Dynamic pass box are used to transfer materials from uncontrolled to controlled environments while Static pas boxes are used to transfer materials between two rooms of equal cleanliness ...

A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to guarantee that stable quality is transferred. ...

A written plan stating, how validation will be conducted and defining acceptance criteria e.g: The protocol for manufacturing process identifies process equipments, critical process parameters, and / or operating range, product characteristics, sampling, test data to be collected, number of validations ...

In the Pharmaceutical Industry there is some possibility of contamination and cross-contamination of products due to inadequate washing of shared facilities. This can lead to severe hazards for the patient, therefore any contamination as well as cross-contamination cannot be afforded in (imagine, for ...

Cleaning Validation is typically performed according to a master validation plan (Cleaning Validation Plan) that will guide the cleaning validation approach and dedicated Cleaning Validation Protocols in which all the relevant cleaning procedures, equipment, areas, analytical methods, sampling plan and ...

When compared to a traceable reference, calibration ensures that the value provided by a measuring device is precise and repeatable. However, it cannot be assumed that the instrument will always deliver precise and repeatable readings after it has been calibrated. Therefore, instrument recalibration ...

Media plates are exposed in the main areas of activity and positioned to capture the maximum amount of particles. Large particles tend to settle faster on the plates due to gravitational force. Smaller particles, however, take some time in settling due to factors such as air currents which drive them ...

Drug discovery crystal ball gazing for the year ahead. And the hottest new prospects are discussed below. We have 1 CDER (FDA) approval this year, an interesting start – Zelsuvmi (berdazimer), a nitric oxide (NO) releasing agent for the treatment of molluscum contagiosum. Berdazimer is a polymeric ...