Saint Mary’s University

School of Health and Natural Sciences

BAYOMBONG, NUEVA VIZCAYA 3700
Analytical Chemistry 2 (Lecture)

Name: Camille M. Donato Date: January 23, 2020

Rating: ____________

ASSIGNMENT 1:
Introduction to
Pharmaceutical Analysis
 1. Define the following terms:
Quality - the standard of something as measured against other things of a similar kind; the degree
of excellence of something.
Quality assurance – the maintenance of a desired level of quality in a service or product, especially
by means of attention to every stage of the process of delivery or production.
Quality control – a system of maintaining standards in manufactured products by testing a sample
of the output against the specification.
Monograph – a detailed written study of a single specialized subject or an aspect of it.
Compendium – a collection of concise but detailed information about a particular subject,
especially in a book or other publication.
Pharmacopeia – a book, especially an official publication, containing a list of medicinal drugs with
their effects and directions for their use. A stock of medicinal drugs.
NF – The National Formulary (NF), established in 1888 by the
American Pharmaceutical Association, includes standards for excipients, botanicals, and other
similar products.
Certificate of analysis – a document issued by Quality Assurance that confirms that a regulated
product meets its product specification. They commonly contain the actual results obtained from
testing performed as part of quality control of an individual batch of a product.
Good Manufacturing Practices – is a system for ensuring that products are consistently produced
and controlled according to quality standards. It is designed to minimize the risks involved in any
pharmaceutical production that cannot be eliminated through testing the final product.
2. Explain comprehensively the role of Pharmacist in quality control and assurance:
This role is responsible for maintaining and improving Quality Standards of the business,
by coordinating and conducting audits as well as evaluating audit reports to ensure corrective and
preventive actions are implemented. You will be required to identify and resolves quality problems
to actively contribute to the quality improvement of existing products. You will assist with
performing final product release and Annual Product Quality Reviews on all required products in
compliance with regulatory requirements.

Reference:
 www.medicinenet.com › script › main › art
 https://www.sigmaaldrich.com/united-kingdom/technical-services/c-of-a.html
 https://ispe.org/initiatives/regulatory-resources/gmp
 Oxford dictionary