GMP

Question 1

What are three objectives of GMP

Answer 1

-Guarantee high quality products
-Ensure product efficacy and stability
-Ensure product safety and free of contaminations.

Question 2

State five things which determine quality of a pharmaceutical product

Answer 2

-Identity of active ingredient should he known
-Purity assured
-Stability, where it works effectively for as long as stated on the label.
-Potency of about 90-110% of the labelled amount
-Good bioavailability
-Uniformity; consistent in color, shape and size

Question 3

State the five components of cGMP

Answer 3

-GMP is a part of QA
-GMPs main function is to produce good quality products consistently
-GMP must meet the legal requirements of the country
-GMP must meet the needs of production and QC related issues
-WHO further comments that the main function of GMP is to avoid mix-ups and contamination risks.

Question 4

Name the key concepts of GMP

Answer 4

Validation
Qualification
Calibration

Question 5

In a production site, equipements should be:

Answer 5

Calibrated
Sterilized
Labelled
Checked
Accompanied with

Question 6

SOPs are written for which procedures? Give five examples

Answer 6

For equipment
For sampling
For for testing
For process
For packaging

Question 7

Draw a schematic to represent quality management

Answer 7

1. Quality management (determine the overall policy of the organization towards quality)
2. Quality assurance (assures that the quality is achieved)
3. GMP (part of QA, deals with reducing risks and builds quality into the product)
4. Production and quality control (focused on testing of the environment, the facility and the materials)

Question 8

State four reasons for compounding practices

Answer 8

1. Drug dose or strength isn’t commercially available
2. Drug isn’t stable and require preparation and dispensing every few days.
3. Patient may be allergic to an excipient found in the commercially available drug
4. The dosage form isn’t commercially available

Question 9

State five functions of BoMRA

Answer 9

-Clinical trial authorization
-Authorization of imports
-Pharmacovigilance/post marketing surveillance
-Registration of medicines and medicines related substances
-Licensing and inspection of pharmaceutical operations
-Testing of medicines and medicines related substances