SEATWORK #1

1. Pharmaceutical Analysis
The pharmaceutical analysis is a branch of chemistry, which involves the series of process for
the identification, determination, quantitation, and purification. This is mainly used for the
separation of the components from the mixture and for the determination of the structure of
the compounds.
Pharmaceutical analysis in drug development mainly focuses on methods to identify and
quantify potential new drug candidates, determine purity, identify by – products and
degradation products in compatibility and stability studies, and to determine the drug
substance’s fate in the organism. Challenging tasks like these require sophisticated techniques,
dedicated equipment and methods operated by highly skilled staff, often with a good academic
background.
2. Quality Control
The term “quality control” refers to the sum of all procedures undertaken to ensure the identity
and purity of a particular pharmaceutical. Quality control in the pharmaceutical industry aims to
verify and test the medicine at various stages of production to ensure every product is of the
highest quality. Quality control also involves identifying product defects and fixing these
problems with corrective techniques and measures.
Quality control (QC) is a process through which a business seeks to ensure that product quality
is maintained or improved. Quality control involves testing units and determining if they are
within the specifications for the final product.
A Quality Control (QC) Analyst checks or tests the product of a manufacturing process to make
sure that it meets predefined quality or safety standards.
The key aspects of quality control in pharmaceuticals include all steps taken by a corporation to
ensure that medicines are pure, safe, and in compliance with regulations. It is critical to address
the policies that regulate the sterility, functioning, and production of pharmaceutical items.
Quality Control (QC) may be defined as a system that is used to maintain a desired level of
quality in a product or service. It is a systematic control of various factors that affect the quality
of the product. It depends on materials, tools, machines, type of labour, working conditions.
QC is a broad term, it involves inspection at particular stage but mere inspection does not mean
QC. As opposed to inspection, in quality control activity emphasis is placed on the quality future
production. Quality control aims at prevention of defects at the source, relies on effective
feedback system and corrective action procedure. Quality control uses inspection as a valuable
tool. According to Juran “Quality control is the regulatory process through which we measure
actual quality performance, compare it with standards, and act on the difference”. Another
definition of quality control is from ANSI/ASQC standard (1978) quality control is defined as
“The operational techniques and the activities which sustain a quality of product or service that
will satisfy given needs; also the use of such techniques and activities”. Alford and Beatty define
QC as “In the broad sense, quality control is the mechanism by which products are made to
measure up to specifications determined from customers, demands and transformed into sales
engineering and manufacturing requirements, it is concerned with making things right rather
than discovering and rejecting those made wrong”.
Quality control can be defined as "part of quality management focused on fulfilling quality
requirements." While quality assurance relates to how a process is performed or how a product
is made, quality control is more the inspection aspect of quality management. An alternate
definition is "the operational techniques and activities used to fulfill requirements for quality."
3. Quality Assurance
Pharmaceutical Quality Assurance is the assurance of quality requirements for a product or
service in the pharmaceutical industry. Quality assurance aims to create and maintain customer
confidence in the product, and the goal is to detect defects early or to prevent them. Quality
assurance in the pharmaceutical industry is a continuous process that focuses on the constant
review of customer requirements. A variety of methods can support this process, but it is also
important to note that quality assurance shall not result in any high additional costs for the
company. The pharmaceutical quality assurance focus is also to reduce costs through quality,
and every action taken to assure quality must follow the applicable standards and laws.
Quality assurance can be defined as "part of quality management focused on providing
confidence that quality requirements will be fulfilled." The confidence provided by quality
assurance is twofold—internally to management and externally to customers, government
agencies, regulators, certifiers, and third parties.
Quality assurance can be defined as "part of quality management focused on providing
confidence that quality requirements will be fulfilled." The confidence provided by quality
assurance is twofold—internally to management and externally to customers, government
agencies, regulators, certifiers, and third parties. An alternate definition is "all the planned and
systematic activities implemented within the quality system that can be demonstrated to
provide confidence that a product or service will fulfill requirements for quality."
4. Percentage Error
A percent error measures the difference between an observed value and a theoretical value as a
percentage of that theoretical value. In other words, a percent error measures just how close a
measured or estimated value of some quantity is to the true and correct value.
Percent error is how large the difference is between an approximate figure and an exact value.
The greater the percent error, the farther away your estimated number is from the known
value, and the lower your percent error, the closer your approximate value is to the actual
value.
5. Analytical Method
Analytical method means a technique used qualitatively or quantitatively to determine the
composition of a sample or a microbial contamination of a sample. Analytical method
development is the creation of a set of experimental conditions to perform analytical
procedures in chemical samples. Developed analytical methods can be used to identify,
separate, quantify, and learn more about the chemical components in drug products intended
for commercial manufacturing.
6. Accuracy
Accuracy refers to the closeness of a measured value to a standard or known value. In numerical
analysis, accuracy is also the nearness of a calculation to the true value; while precision is the
resolution of the representation, typically defined by the number of decimal or binary digits.
7. Precision
Precision is the closeness of agreement between individual results obtained from a repeatedly
applied procedure in a homogeneous sample, comprising repeatability and IP. 5 It is expressed
as the standard deviation or coefficient of variation.
In chemistry, precision refers to the reproducibility of a result or measurement. In other words,
precision refers to the closeness of two or more measurements to each other.
8. Linearity
Linearity is the ability of obtaining results that are directly proportional to the analyte
concentration in the sample, across the specified range, i.e., the interval between the upper and
lower levels of analyte. Linearity studies are important because they define the range of the
method within which the results are obtained accurately and precisely.
9. Robustness
The robustness of an analytical procedure is a measure of its capacity to remain unaffected by
small, but deliberate variations in method parameters and provides an indication of its reliability
during normal usage.
Robustness Analysis is the process of analyzing a design's performance in the presence of
variation effects such as voltage, process, and temperature. Robustness is ability of system to
resist change without adapting its initial stable configuration.
10. Pharmacopoeia
A pharmacopoeia is an official book that lists all the drugs that can be used to treat people in a
particular country, and describes how to use them. A book describing drugs, chemicals, and
preparations used in medicine.
The core purpose of a pharmacopoeia is to help ensure that medicines and their ingredients are
safe, effective, and of appropriate quality. The standards define the specifications that
pharmaceutical ingredients and products on the market must fulfill throughout their shelf life.
Pharmacopoeia a book containing directions for the identification of sample and the
preparation of compound medicines and published by the authority of a government or a
medical or a pharmaceutical society. Legally recognized compendium of standards for drugs,
revised periodically.

11. Limit of Detection

The detection limit of an individual analytical procedure is the lowest amount of analyte in a
sample which can be detected but not necessarily quantitated as an exact value.
The limit of detection LOD (or detection limit, DL) is the lowest possible concentration at which
the method can detect (but not quantify!) the analyte within the matrix with certain degree of
confidence. It is also defined as the lowest concentration that can be separated from a
background noise with some reliability.
The Limit of Detection (LOD) for an analytical procedure is the concentration of an analyte,
which results from the smallest measure that can be detected with reasonable certainty. The
LOD for a method is determined during method validation after taking into account the
capabilities of the instrumentation used, the nature of the samples being tested, any
interferents which they may contain and the way in which the samples are prepared for the
analysis.
12. Limit of Quantification
The Limit of Quantification (LOQ) is the lowest analyte concentration that can be quantitatively
detected with a stated accuracy and precision [24]. However, the determination of LOQ
depends on the predefined acceptance criteria and performance requirements set by the IA
developers.
The LOQ is the limit at which we can reasonably tell the difference between two different
values.
13. Pharmacopoeia
A pharmacopoeia is an official book that lists all the drugs that can be used to treat people in a
particular country, and describes how to use them. A book describing drugs, chemicals, and
preparations used in medicine.
14. Monograph
Monographs articulate the quality expectations for a medicine including for its identity,
strength, purity, and performance. They also describe the tests to validate that a medicine and
its ingredients meet these criteria.
A pharmacopeial monograph provides detailed parameters that are used to determine whether
a medicine meets key quality attributes and can be marketed legally in any given country.
15. Validation
Method validation is a critical activity in the pharmaceutical industry. Validation data are used to
confirm that the analytical procedure employed for a specific test is suitable for its intended
purposes. These results demonstrate the performance, consistency, and reliability of the
analytical method.

ASSIGNMENT #1
USP MONOGRAPH
I. Illustrate the parts of a monograph

Title Page

Every thesis must have a title page. Include on the title page the:

 title of the thesis

 author of the thesis
 academic unit (or department, faculty, etc.) of the University
 “University of Ottawa” (or “Saint Paul University”)
 phrase “A Thesis Submitted in Partial Fulfillment of the Requirements for the Degree
of ...”
 degree sought, and
 copyright symbol followed by the author’s name and the current year.
o Template - Cover page (.doc)

Table of Contents

The Table of Contents should be detailed and include:

 everything that comes after, including the Abstract and Acknowledgements, and;
 not just chapter titles but various levels of headings within chapters and sections.

Take a look at various tables of contents to become familiar with what’s expected in your
program.

List of Tables

Provide a separate page with a list of tables used in the text. Include the:

 table number
 full title of the table, and
 page number where the table appears in the text.
 tables in the text must be numbered in order of appearance.
List of Figures

Provide a separate list of figures. The same conventions that apply to the list of tables apply
to the list of figures.

Formatting and placement requirements for tables, figures, and other graphics vary by
department and discipline. Check your academic unit’s specific requirements.

Legend

List and explain all acronyms or symbols used frequently in your text.

Abstract

A thesis is preceded by an abstract or summary which may include the following:

 a statement of the problem or a thesis statement

 a summary of the methodology: a description of the approach taken in the thesis, the
research, and/or the methods of investigation
 the main points made in the thesis or a summary of the main findings, and
 general conclusions.

Abstracts should be provided both in English and in French (except for thesis in English
Literature and Lettres françaises). They should be:

 150 words for a master’s thesis, or

 300 words for a doctoral thesis.

The Acknowledgements or Preface

The two terms “acknowledgements” and “preface” are used interchangeably. In an

acknowledgements section or incorporated into a preface or foreword, you may want to
mention who helped you intellectually.

Who funded your research? Who directly helped you along the way? You might have had
assistance with your research, or some experiments or data analysis. All these contributions
must be fully acknowledged.

A preface or a similar statement of the contributions of co-contributors must be included in

a thesis where ethics approval was required, where any material used in the thesis was the
result of a collaboration with co-authors, and/or where the thesis includes any material
previously published.
In a thesis that is an article or a series of articles, the student is obliged to describe his or her
own contribution to any articles that have been co-authored. In considerable detail, with
references to page numbers and chapters, the preface must clearly describe, summarize and
distinguish the contributions of the student from those of all other collaborators or co-
authors. All these other contributors must be clearly identified.

As well as being summarized in the acknowledgements or preface, this same information

should, of course, also be stated plainly in footnotes/endnotes in the text.

Many students include acknowledgements of help of a personal nature in this section,

something that is entirely at their discretion, as distinct from the obligatory
acknowledgements mentioned above.

Copyrighted Contents

If published material—your own or that of other authors—has been used, you must obtain
written permissions to use these materials. This written permission usually comes from the
publisher.

Introduction

Introductions can take many forms, but in general the introduction presents the hypothesis
or thesis statement and a brief overview of the thesis.

Body of the Thesis

The main part of the thesis usually consists of chapters and sections within these chapters.

Conclusion

The conclusion sums up the content and findings of the thesis and ideally goes a step
further, suggesting areas for further research and investigation.

Appendices

Materials considered useful but not central to the argument of the thesis are best placed in
appendices. In addition, the actual documents confirming ethical approvals, are often placed
here rather than in the body of the thesis.

Footnotes/Endnotes

These must be prepared using the appropriate scholarly conventions of your academic unit
and your discipline. Find out what the proper conventions are for your discipline and follow
them right from the first draft. Ask your supervisor to recommend a style guide, and refer to
it often.

Bibliography

Bibliographic entries must also be prepared using the appropriate scholarly conventions of
your academic unit and discipline. Refer to your style guide.
II. Enumerate the parts of a monograph
 Title Page
 Table of Contents
 List of Tables
 List of Figures
 Legend
 Abstract
 The Acknowledgements or Preface
 Copyrighted Contents
 Introduction
 Body of the Thesis
 Conclusion
 Appendices
 Footnotes/Endnotes
 Bibliography
III. Define/ Give a brief description of the parts of a monograph