BPS 4102 BIOPHARMACEUTICAL GUIDELINES AND
REGULATIONS QUESTIONS AND ANSWERS | BPS 4102 STUDY
GUIDE & PRACTICE TEST 2026/2027
What is a Biologic? - Correct answer ✔✔ A drug product derived from a living organism: animal,
plant or microbe.
List Differences between Biologics and Conventional Pharmaceuticals. - Correct answer ✔✔ 1.
Quality can not be established entirely by tests on the material in the final container.
2. Test methods are variable in nature. Bioassays have a high degree of variability/invalidity.
3. Products are heat sensitive and are stored at 2-8C. Certain operations may need to be
performed under controlled temperatures (below 10C sometimes).
4. Highly susceptible to microbial growth. Microbial contamination must be considered at every
step.
Provide a brief history for a Regulation of Drugs - Correct answer ✔✔ 1. Inland Revenue Act of
1876: Control Adulteration in alcohol.
2. Adulteration Act of 1884: Adulterated food and drugs.
3. Proprietary or Patent Medicine Act [PPM] 1909: Passed over concerns over safety of "secret
ingredient" of drugs.
4. Opium and Narcotic Control Act of 1920: Controls narcotic drugs.
5. Food and Drug Act 1920: Replaces Adulteration Act of 1884.
- Defines Drug
- Gives Governor in Council power to make regulations and prescribe the duties of the inspector.
6. Food and Drug Amendment 1927: Minister has power to license biological products.
REGULATIONS QUESTIONS AND ANSWERS | BPS 4102 STUDY
GUIDE & PRACTICE TEST 2026/2027
What is a Biologic? - Correct answer ✔✔ A drug product derived from a living organism: animal,
plant or microbe.
List Differences between Biologics and Conventional Pharmaceuticals. - Correct answer ✔✔ 1.
Quality can not be established entirely by tests on the material in the final container.
2. Test methods are variable in nature. Bioassays have a high degree of variability/invalidity.
3. Products are heat sensitive and are stored at 2-8C. Certain operations may need to be
performed under controlled temperatures (below 10C sometimes).
4. Highly susceptible to microbial growth. Microbial contamination must be considered at every
step.
Provide a brief history for a Regulation of Drugs - Correct answer ✔✔ 1. Inland Revenue Act of
1876: Control Adulteration in alcohol.
2. Adulteration Act of 1884: Adulterated food and drugs.
3. Proprietary or Patent Medicine Act [PPM] 1909: Passed over concerns over safety of "secret
ingredient" of drugs.
4. Opium and Narcotic Control Act of 1920: Controls narcotic drugs.
5. Food and Drug Act 1920: Replaces Adulteration Act of 1884.
- Defines Drug
- Gives Governor in Council power to make regulations and prescribe the duties of the inspector.
6. Food and Drug Amendment 1927: Minister has power to license biological products.
