Quality Systems in Pharmaceutical Industry

Question 1

What do Regulatory Agencies control?

What are they controlled by?

Answer 1

• Control
  
  • Human pharmaceuticals, veterinary products, costmetics and food
  • Control imports into the country and some control exports
• Each country has their own agency, controlled by the Government

Question 2

Are there any international Regulatory Agencies?

Answer 2

• The scope of legislation is restricted to the country
• There are no international agencies

Question 3

What are the activities of Regulatory Agencies?

Answer 3

• Approval of clinical trials applications
• Guidance and advice to industry
• Approval for marketing
• Post-marketing surveillance
• Monitoring of GMP and GLP compliance

Question 4

What is the overall purpose of the TGA?

Answer 4

• Protect public health and safety by regulating therapeutic goods that are supplied either imported or manufactured or exported from Australia

Question 5

What does the TGA control?

Answer 5

• Medical devices, blood and tissues
• Clinical Trial Notifications
• Vaccines
• Sunscreens
• Antibacterial hand washes
• Medicines (incl. pregnancy database)
• Recalls and alerts
• Registry of drug and device related problems

Question 6

What is the Major Objective of Quality Assurance?

What does QA primarily involve?

Answer 6

• The major objective is to ensure that pharmaceutical products are of required quality, to provide desired safety and efficacy
• Primarily involves:
  
  • Review and approval of all procedures related to production and quality control
  • Review of associated records
  • Auditing
  • Trend analyses

Question 7

What are the Roles of Quality Control?

What does QC cover?

Answer 7

• The roles of QC include:
  
  • Development of release specifications and test procedures
  • Sampling and testing
  • Documentation
  • Releasing the batch only if found to be satisfactory i.e. within specifications
• QC usually covers:
  
  • Checking raw materials, in-process materials, finished products and packaging components for compliance with the specifications
  • Evaluating the manufacturing process in line with the specifications and limits
  • Release control and recalls if any

Question 8

GMP covers all aspects of the manufacturing process including:

Answer 8

• Acceptance of raw materials
• Processing including in process quality control
• QC pass of finished product
• Storage and distribution of the finished product

Question 9

What does GMP cover?

Answer 9

• Quality Management
• Premises and Equipment
• People
• Documentation
• Production
• Contract manufacturing and analysis
• Complaints and products recalls
• Audits and inspections

Question 10

What is GLP?

Answer 10

• Applicable to analytical and toxicological laboratories
• Refers to a set of principles and procedures to be followed in compliant laboratories, to ensure reliability, traceability and reproducibility of the data generated