Process Validation of Pharmaceutical Dosages Form: A Review by Priyambada Pandey in BJSTR
Abstract
Quality is always an imperative prerequisite when consider any
product. Therefore, drugs must be manufactured to the highest quality
levels. Validation is a part of the quality assurance program and is
fundamental to an efficient production operation for building quality
into
the products. Validation of the individual steps of the processes is
called the process validation. Process validation involves the
collection
and evaluation of data, from the process design stage throughout
production, that establish scientific evidence that a process is capable
of
consistently delivering a quality drug substance. The goal of the
validation is to ensure that quality is built into the system at every
step, and not
just tested for at the end. It involves the collection and evaluation of
data, from the process design stage throughout production, that
establish
scientific evidence that a process is capable of consistently delivering
a quality drug substance. Process validation is an integral part of
Quality
Assurance as per cGMP. Validation and quality assurance will go hand in
hand, ensuring the thorough quality for the products. Hence, an
emphasis made on to review that gives a detailed, overview of
validation. According to GMP, validation studies are required to be done
as per
predefined protocols. Different dosage forms have different validation
protocols. The purpose of this work is to present an introduction and
general overview on process validation of pharmaceutical manufacturing
process with special reference to the requirements stipulated by the
US Food and Drug Administration (FDA) of Solids (tablets and capsules),
liquids and semisolids.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.