Pharmaceutics – Assignment #1

Do either A or B, not both

Interpret the information and write the
assignment in your own words
Marks will be deducted for plagarism
Due February 5
 Pharmaceutics – Assignment A
cGMP:

- Choose 5 topic headings from within the cGMP

regulations ( e.g. personnel, sanitation, equipment,
finished product testing, etc) IN YOUR OWN WORDS,
explain basically what they are and the rationale
behind them, why are they important and how they
might relate to each other and how they help to
ensure product quality
 Pharmaceutics – Assignment B
Principles of GLP

- List the 5 components of GLP and IN YOUR OWN

WORDS, explain basically what they are and the
rationale behind them, why are they important,
specific points within each heading, how they might
relate to each other and how they help to ensure
product quality
 Pharmaceutics – Assignments
Write the assignments as you would for
someone who knows nothing about GMP or
GLP. (This is the way most reports should
basically be written)

Remember, the purpose of the assignment is to

educate the reader in GMP and GLP so don’t
assume the reader knows what you mean
 Pharmaceutics – Assignments
All activities performed at work should contain
an element of added value. If not, are we
working to a high standard of quality?
What does this mean?
1. Going beyond the minimum required (bare
minimum)
2. Improving on exisiting ways
3. Making the other persons job easier
 Pharmaceutics – Assignments

4. Being resourceful and creative (innovative)

5. Providing what co-workers need and what they
don’t know they need
6. Putting yourself in their shoes

• People that add value are generally more

successful
• In this way, quality is continuous (on going) and
improvement is inherent – what is morale?
 Pharmaceutics – Assignments
These six points of added value apply to report
writing as well ( ie assignments, projects, etc)

These are what separate average reports from

good ones

Marks will be given for value added attributes

 Pharmaceutics – Assignments
Resources:
• Pharmaceutics Lecture Handouts Pg’s 32 – 49:
HPFB (TPD) Regulations and GMP
• Pg’s 50 – 63: Principles and Fundamentals of
GLP
• Ch 3 of text, pg 67-74,table 3.1 and other
reference texts
• Power point class notes
• Internet information – include references