QA lec 3

Question 1

Documentation and records

Answer 1

• If it is not written down it is a rumour
• GMP stands for Great Mounds of paper
• It is the backbone of any Quality Assurance systems

Question 2

Objectives of documentation

Answer 2

• State in advamce what has to be done
• Do it in accordance with the instructions
• Make record of what has been done

Question 3

Reason of documentation

Answer 3

• Approved instructions
  
  • Reproducible products
  • Training
• Defined standards
• Confirmation that steps have been carried out
• Records
• Investigation of complaints
• Help necessary corrective actions

Question 4

Types of documentation

Answer 4

• Specifications
• Manufacturing and packaging instructions
• Standard operating procedures (SOP’s)
• Records

Question 5

Specification

Answer 5

• State standards which materials and products should meet
• Describe the tests for the standards
• Include
  
  • Starting materials
  • Packahing materials
  • Intermediate and bulk products
  • Finished products

Question 6

Manufacturing and packaging instructions

Answer 6

• State all the starting materials
• Detail all processing and manufacturing details
• Describe packaging processes

Question 7

Standard operating procedures

Answer 7

• SOP’s
• Directions or information on performing operating
• Examples
  
  • Cleaning
  • Changing
  • Equipment operation
  • Environment monitoring

Question 8

Records

Answer 8

• Product batch history
• Include
  
  • Issue and receipt of starting materials
  • Production and packaging records
  • Distribution records
  • Complaint records
  • Exception and out-of-spec records
  • Training records
  • Plant and Equipment records

Question 9

Orange guide

Answer 9

• Chapter 4 is a general list of all documents required and what should be in then
• E.g. specification for finished product should include
  
  • Name
  • Formula
  • Pharmaceutical form and packaging
  • Sampling and testing methods
  • Test limits
  • Storage, handling and shelf-life

Question 10

Documentation control

Answer 10

• All documents are available to those that need them
• Kept up to date staff aware of updates
• Revisions formal and authorised
• Copy numbers
• Records who is issued with copies
  
  • Use a table on the reverse of the master sheet
• Removal of all superseded copies

Question 11

The NPA helps

Question 12

NB- do the exercise on the PP once you have gone through the material