Pharmaceutical

Manufacturing and
CGMP
SESSION 3
 11. Which of the following is not an example of physical contamination?

I. Fiber material II. Particles III. Moisture IV. Gases V. Chips from pill
press tooling

A. I and II B. II and III C. III and IV D. IV and V E. III, IV

and V
Answer: C
Physical contamination. Examples: fiber material, particles, chips from your pill press tooling.
Chemical contamination. Examples: vapor, gasses, moisture, molecules.
Biological contamination. Examples: fungus, bacteria, virus.
12. A leak in the holding containment would contaminate the product inside it is an example of:
A. Physical contamination B. Chemical contamination
C. Biological contamination D. Both A and B E. All of the above
Answer: A
Physical contamination would be physical objects that contaminate the food. An example of this is dirt or debris
that falls into the product after it has been manufactured or while it is being packaged.
13. Which of the following are sources of contamination?
I. Foot wear
II. People
III. Design of building
IV. Air-conditioning services
V. Equipment

A. I and II B. I, II and III C. I, II and IV D. I, II and IV E. All of the above

Answer: E
Premises and design of building, equipment, people, heating ventilation and air conditioning system, clothing,
processing
operations, and utilities and services are sources of contamination.

14. Contact surfaces of equipment should be inert, additive and absorptive.

A. True B. False
Answer: B
The equipment contact surfaces should be inert, not be additive or absorptive.
15. Self-contained facilities should be available for antibiotics.
A. True B. False

Answer: A
To minimize the risk of medical hazard due to cross-contamination, dedicated and self-contained
facilities should be available for particular medicinal such as beta lactam products, antibiotics,
hormones, cytotoxic, drugs manufacturedfrom live microorganisms.
 SESSION 4
1. As part of Good Documentation Practices, the records should be written legibly and be understandable.
A. True
B. False
C. I don’t know
ANSWER: A
A document is unusable if it cannot be read, so care must be taken to ensure that handwriting is legible. All
entries must be made at the time the tasks are performed and should be legibly signed and dated.

2. As part of Good Documentation Practices, putting the dates is not required unless stated by the supervisor.
Backdating is also okay.
A. True
B. False
C. I’m not sure
ANSWER: B
Always record the entries at the time of activity simultaneously.
Always record date with the signature in GMP records.
Never backdate GMP records
Time should be entered in 24:00-hour cycle. Record the time in HH: MM format. For Example 11:05 AM
should be written as 11:05 and 11:05 PM should be written as 23:05.
 SESSION 4

3. In Good Documentation Practices, it’s okay to use pencil for writing so you won’t
cross out writings when mistakes are made.
A. True
B. False
C. I’m not quite sure

ANSWER: B
All records must be filled out in indelible BLACK or BLUE ballpoint pen for long-term
legibility. Do not use pencil or ink that can be erased.
 SESSION 4

4. This refers to the organizational process and conditions under which laboratory
studies are planned, performed,
monitored, recorded, and reported.
A. Good Manufacturing Process
B. Good Laboratory Practices
C. Good Documentation Practices
D. cGMP
E. None of the above
ANSWER: B
Good Laboratory Practices (GLP) refer to the organizational process and conditions
under which laboratory studies are planned, performed, monitored, recorded, and
reported. This involves a system of protocols that should be followed in order to
avoid the production of unreliable or erroneous data.
 SESSION 4

5. Good Laboratory Practices include:

A. Smelling and tasting chemicals
B. Not washing your hands before entering the laboratory
C. Confining loose hair and loose clothing
D. Using damaged equipment and glassware
E. Not wearing safety goggles when working

ANSWER: C
The laboratory should have sufficient personnel with the necessary education,
training, technical knowledge and experience for their assigned functions. The
personnel should be provided with appropriate clothing suiting to their needs and
the clothing should be of nature, which will prevent microbiologically chemical
contamination.