This article looks at one of these aspects: determining the locations for monitoring and here a risk assessment tool can be applied for this purpose: Hazard Analysis and Critical Control Point (HACCP).
The announcement of a FDA inspection can trigger fear emotions to many in the company. If you have not been through an inspection, it can be difficult to know how to prepare for the inspection. This paper discusses some of the inspectional concerns of FDA and expands on the guidance to describe how it may be interpreted.
An important aspect of the selection and evaluation of disinfectants is the disinfectant qualification programme. After a disinfectant has been chosen based on its chemical properties and expected performance/effectiveness, each disinfectant should be assessed to ensure its efficacy.
In order to prepare for a successful FDA inspection, QC management and analysts must know and understand the types of FDA inspections and their purpose, the Good Manufacturing Practice (GMP) regulations, FDA guidance documents and compliance manuals, and current expectations and inspection trends.
In the pharmaceutical, medical devices and the healthcare industry, sampling is an important quality control activity to ensure product quality through testing. Sampling activity performed at the end of a manufacturing process provides a check on the adequacy of the quality control procedures of the manufacturing department.
Rapid Microbial Methods (RMM) have been available in the pharmaceutical industry for many years. The implementation of RMMs is becoming more accepted in the Pharmaceutical industry, the introduction of these alternative technologies have allowed for faster time to results, reduction in subjectivity in results, and higher output which helps with...
There are some gaps in the regulatory guidelines which lead to some misconceptions among stakeholders or even direct misuse. One of such cases is the manufacturing date for drug substance.