Good manufacturing process

Question 1

What is large-scale manufacturing?

Answer 1

Pharmaceutical industry -
quality control takes place
licensed products made
mass production - no consideration of individual patients needs

Question 2

What is small-scale manufacturing?

Answer 2

Extemporaneous preparations in a Pharmacy

Question 3

Why is there a need for extemporaneously preparing some products?

Answer 3

When there is no licensed product available
When a product is discontinued
When an individualised dose is required
When an individualised formulation is required

Question 4

Does the law allow Pharmacists to prepare and supply medicines in a pharmacy without the need for the product to be licensed?

Answer 4

Yes

Question 5

What is specials manufacturing?

Answer 5

Companies that make bespoke products

Usually for toxic or complex preparations

Question 6

What are the two reference sources for standard formulas?

Answer 6

British Pharmacopeia (BP)
Pharmaceutical Codex

Question 7

Records of prepared products need to be kept for a minimum of how many years?

Answer 7

2

Question 8

How is the expiry date for a product that is manufactured large scale determined?

Answer 8

Accelerated stability testing

Question 9

How is the expiry date for a product that is manufactured extemporaneously determined?

Answer 9

Monograph - if not available then the shortest possible date

Question 10

Freshly prepared liquids expire after how long?

Answer 10

2 weeks

Question 11

Stable preparations i.e. solid external and internal products expire after how long?

Answer 11

3 months

Question 12

Unstable preparations i.e. liquids, semi-solids expire after how long?

Answer 12

4 weeks