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INTRO TO BIOPHARM ENG > Regulatory Affairs > Flashcards

Flashcards in Regulatory Affairs Deck (17)
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1
Q

What is meant by regulatory affairs?

A

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

2
Q

List the 8 responsibilities of regulatory affairs for pharmaceuticals.

A
  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.
3
Q

List the 4 main regulatory bodies.

A
  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)
4
Q

Define GMP with respect to regulatory affairs.

A

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

5
Q

List some of the things that the FDA regulate.

A
  • Organisation & personnel
  • Production & process control
  • Equipment
  • Quality Control unit
  • Laboratory control
6
Q

What are the 4 stages of regulatory affairs?

A
  1. CMC - Chemical, Manufacturing & Control
  2. Clinical
  3. Operations
  4. Strategy
7
Q

What is involved in regulatory CMC?

A

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

8
Q

What is involved in regulatory clinical affairs?

A

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

9
Q

What is involved in regulatory operations?

A

Publishing & submission to FDA.

10
Q

What is involved in regulatory strategy?

A

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

11
Q

What is a pharmaceutical dossier?

A

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.

12
Q

Why is regulatory affairs essential for a pharmaceutical company?

A

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.

13
Q

Describe the 3 FDA guidelines for laboratory control?

A
  • 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.
14
Q

Describe the 3 FDA guidelines for production & process control.

A
  • Written procedures followed showing drug strength, quality & purity
  • Documentation at time of performance
  • Batch formulated with no less than 100% of API.
15
Q

Describe the 3 FDA guidelines for equipment.

A
  • Appropriate design, size& location
  • Equipment & utensils, cleaned maintained & sanitised.
  • No surfaces reactive, additive or absorptive.
16
Q

Describe the 3 FDA guidelines for personnel.

A
  • Clean clothing & PPE
  • Good sanitation & health
  • Authorised personnel only in limited designated areas.
17
Q

Describe the 3 FDA guidelines for the quality control unit

A
  • 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.