Topic 1 ECH4204

GMP (Goods Manufacturing Practices) outlines a quality approach to the following:

Select all that apply

a) Labelling

b) Packaging

c) Manufacturing

d) Storage and Distribution (Shipping of Drugs)

• All of the above

• a, b and c

• b,c and d

• a and c

The Quality Mindset involves Accountability, and as a Roche employee that means:

Select all that apply

a) Always checking my work

b) Never make a mistake

c) Following valid processes

• All of the above

• a and b

• a and c

• b and c

Several tragedies in the early 20th century lead to which change(s) in how drugs are made available to the public?

Select all that apply

a) Requirement to provide expiry dates

b) Requirement for proof of effectiveness

c) Requirement for regulatory approval / authorization

d) Requirement for safety studies

• All of the above

• a, b and c

• b,c and d

• a and c

Good Manufacturing Practices were first formalized in the…

• 1890s

• 1920s

• 1960s

• 1990s

cGMP Prohibits false therapeutic claims

• True
• False
• Not Sure
• May be

PIC/S stands for Pharmaceutical Inspection Co-operation Scheme

• True
• False
• Maybe
• Not Sure

Training is not a GMP requirement

• True
• False
• Maybe
• Not Sure

Protect materials and product from contamination and restricted access are the GMP requirement 

• True
• False
• Maybe
• Not sure

Which of the following statements are correct?

• Processes should be Validated, Robust, Produce uniform product, Protect  product from contamination, Controlled, Cleanable and kept clean
• There should be procedures for all pieces of equipment that explain how to disassemble, how to clean, how to reassemble, how to operate, and where necessary, how to trouble shoot
• Quality needs to be designed into the product from the very beginning of its lifecycle
•  All the above

5P’s covers People, Premises, Product, Processes and Procedures

• True
• False
• Maybe
• Notsure