Byrn Lecture 3

Question 1

Personnel of a Drug Company

Answer 1

Quality Control Unit

Employees

Consultants

Question 2

Buildings and Facilities

Answer 2

• structure, space, design, and placement of equipment must be good enough to enable cleaning, inspection, and safe use
• must be inspected by a supervisor and signed off

Question 3

Equipment

Answer 3

• appropriate designs and sizes
• facility must be kept clean, use intended, and maintained

Question 4

Control of Components, Containers, and Closures

Answer 4

• contains written procedures of a receipt, identification, storage, handling, sampling, and approval/rejection of drug product components

Question 5

Production and Process Controls

Answer 5

• ensure correct identify, strength, quality, and purity
• any deviation must be recorded
• all product ingredients, equipment, and containers must be indentified

Question 6

Packaging and Labeling Control

Answer 6

• expiration dating

Tamper-Evident Packaging
- containing more than one indicator or barrier to entry with
- once was replaced with cyanide tablets to kill people and poison (Tylenol Killer)

Question 7

Holding and Distribution

Answer 7

• stored and shipped under appropriate conditions
• written procedures of holding and distribution of products

Question 8

Laboratory Controls

Answer 8

• written specifications, standards, sampling plans, test procedures, and other mechanisms

Question 9

Records and Reports

Answer 9

complete production, control, and distribution records

Question 10

Returned and Salvaged Products

Answer 10

• must be identified by lot number
• product quality will be determined through testing
• salvaging and reprocessing are only allowed if specifications are met

Question 11

Information Technology and Automation

Answer 11

• scanners to ensure correct drugs are being used
• robotic devices

ADVANTAGE: time saving and effective

Question 12

FDA Inspection

Answer 12

• 50 people died by injections at this specific center
• two pharmacists were indicted for murder and lawsuits
• this compounding centers did not insert preservatives, only the drug

Question 13

NECC FDA Inspection

Answer 13

• 83/321 vials contained a greenish-black foreign matter
• 25% of the vials produced were faulty and contaminated
• a tarnished discoloration on the interior surface of autoclave
• large equipment produced airborne particulates causing rooftop units to serve approximately 100 ft from recycling facility –> located near a dump

Question 14

Results of NECC Inspection

Answer 14

• raw materials included API that were non-sterile

PURCHASING PROBLEMS
EQUIPMENT AND FACILITIES

• surface samples of facility contained mold and bacteria
• air samples from many sites contained bacteria and mold due to turning off air conditioner

IMPROPER FACILITIES

• found bacteria in clean room sampling
• no evidence of Corrective Action

INEFFECTIVE QUALITY SYSTEM

Question 15

Wheel Of Drug Product

Answer 15

1. Product Design (10,000 new drugs entering)
2. Process Design (crystallization, formulation, controls)
3. Process Performance (design space and control)
4. Product Performance (blood levels and pharmacokinetics to be tested)
5. Product Quality Attributes (melting point)
6. Process parameters (stirring rate, temperature)
7. Process Controls
8. Product Specifications (binding quality standards)
9. Product Knowledge (what exactly it is doing)
10. Process Understanding (understand how we are making it and more efficient)