Regulatory Affairs

Question 1

What is meant by regulatory affairs?

Answer 1

A profession developed by the governments desire to protect public health by controlling the safety & efficacy of products in areas such as pharmaceuticals.

Question 2

List the 8 responsibilities of regulatory affairs for pharmaceuticals.

Answer 2

1. Documentation for regulatory bodies
2. Advice on legal & scientific requirements
3. Collect, coordinate & evaluate scientific data from R&D
4. Support clinical trials
5. Provide regulatory strategic direction to clinical teams for phase 1
6. Prepare & review technical reports for regulatory adequacy & compliance.
7. Submitting clinical trial reports to bodies
8. Obtaining approvals, permissions & licenses.

Question 3

List the 4 main regulatory bodies.

Answer 3

1. MHRA - Medicines & Health Regulatory Agency (UK)
2. WHO - World Health Organisation (UN - Geneva)
3. FDA - Food & Drug Administration (US)
4. EMA - European Medicines Agency (Europe)

Question 4

Define GMP with respect to regulatory affairs.

Answer 4

Good Manufacturing Affairs - quality assurance of medicinal products are of consistent quality & control as required by marketing authorisation & product specification.

Question 5

List some of the things that the FDA regulate.

Answer 5

• Organisation & personnel
• Production & process control
• Equipment
• Quality Control unit
• Laboratory control

Question 6

What are the 4 stages of regulatory affairs?

Answer 6

1. CMC - Chemical, Manufacturing & Control
2. Clinical
3. Operations
4. Strategy

Question 7

What is involved in regulatory CMC?

Answer 7

Provides documentation and approvals from scientific understanding & ability to interpret raw data concerning APIs. Provide leadership & strategy from development to manufacturing, licensing & market.

Question 8

What is involved in regulatory clinical affairs?

Answer 8

Getting a drug from research through clinical trials to market inc data, statistics & documentation.

Question 9

What is involved in regulatory operations?

Answer 9

Publishing & submission to FDA.

Question 10

What is involved in regulatory strategy?

Answer 10

Develop strategy for; market, submissions, initiating clinical trials, location from start to final publishing.

Question 11

What is a pharmaceutical dossier?

Answer 11

A document containing all the necessary information as required by a respective countries drug regulation authority. Without one, a drug cannot market or be traded.

Question 12

Why is regulatory affairs essential for a pharmaceutical company?

Answer 12

The environment is competitive so the time taken to market will effect the company’s success. Therefore, it is important the regulatory affairs is conducted properly to avoid disruption.

Question 13

Describe the 3 FDA guidelines for laboratory control?

Answer 13

• Establish specs, sampling, tests & documentation
• Conformance to specs with raw materials & samples
• Testing of drug products against conformance of final spec inc strength of API.

Question 14

Describe the 3 FDA guidelines for production & process control.

Answer 14

• Written procedures followed showing drug strength, quality & purity
• Documentation at time of performance
• Batch formulated with no less than 100% of API.

Question 15

Describe the 3 FDA guidelines for equipment.

Answer 15

• Appropriate design, size& location
• Equipment & utensils, cleaned maintained & sanitised.
• No surfaces reactive, additive or absorptive.

Question 16

Describe the 3 FDA guidelines for personnel.

Answer 16

• Clean clothing & PPE
• Good sanitation & health
• Authorised personnel only in limited designated areas.

Question 17

Describe the 3 FDA guidelines for the quality control unit

Answer 17

• Adequate lab facilities inc. containers, materials, packaging &labelling
• Approving or rejecting all procedures that impact strength, quality & purity
• Responsibilities for quality control should be written & followed.