QA- lec 6

Question 1

Validation

Answer 1

• Is the action of proving, in accordance with the principles of GMP, that any procedure, proves, equipment, material, activity or system actually leads to the expected results

Question 2

Qualification

Answer 2

• is the action of proving that any equipment works correctly and actually leads to the expected results
• The word validation is sometimes widened to incorporate the conveptof qualification

Question 3

Validation-2

Answer 3

• It is the conceptually quite simple, but that the emphasis terminology and definition has enabled a few individuals to build empires within their firms or create lucrative side of business
• It is not going to go way and in basicessence the concept of validation is a simple and valuable one

Question 4

What needs validation

Hospital aseptic practice

Answer 4

• Isolators
• Clean rooms
• Computers
• Automated filling equipment
• Production process
• Packaging
  
  • Syringe, hubs, infusion device, bags

Question 5

What needs validation

Answer 5

• Cleaning process
  
  • Does it clean effectively, deposits of product and or deposits of cleaning agents
• Sterlility test
• QC instruments
  
  • Active air samples
• Change
  
  • Facilities, equipment and processes

Question 6

Where to start

Answer 6

• Risk analysis
  
  • What needs doing
  • In what order
  • How much work needs doing
• Validation Master plan
  
  • How are you going to do the work

Question 7

Validation master plan

Answer 7

• Important document or booklet
• Defines the company policy on validation
• describes the general process to validation
• Lists the equipment and process to be validation
• Defines the priority order

Question 8

Qualification (equipment) terms

Answer 8

• Design Qualification (DQ)
  
  • Design is suitable for use
• Installation Qualification (IQ)
  
  • As installed or modified, complies with design
• Operational Qualification (OQ)
  
  • Performs through-out the operational range
• performance Qualification (PQ)
  
  • Continues to perform during operational life

Question 9

Validation workbook

Answer 9

• Important document or booklet second to the VMP
• One booklet for each instrument or process to be validated
• Four main sections DQ, IQ, OQ and PV

Question 10

Validation workbook sactions

Answer 10

• Each of the four main sections divided into
  
  • Method statement (how you are going to do it- including specification or expected results)
  • Sign off of method statement
  • Results
  • Out of specification results
  • Sign of and move to next section

Question 11

Process validation (production)

Answer 11

• Mixing, filling, cleaning
  
  • Sample top, middle, bottom of tank
  • 50%, 100%, 150% of mixing
• Filling
  
  • Number, volume, container, quality
• Cleaning
  
  • Swabs and final rinse solutions

Question 12

Process validation (options)

Answer 12

• Prospective Validation
  
  • Before you market your product
• Concurrent Validation
  
  • During routine production
• Retrospective validation
  
  • Based on accumulated manufacturing, testing and control batch data
• Perform the laast two following a retrospective gap analysis