Basic Principles of GMP

1
Basic Principles of GMP
Contract Production and Analysis
Section 7
2
Contract Production and Analysis

• Objectives
• To review general issues
• To understand the responsibilities of
• Contract giver
• Contract acceptor
• To understand the contract

3
Contract Production and Analysis

• Principle
• Contract production and analysis must be
  correctly defined, agreed, and controlled
• To avoid misunderstandings that could result in
  unsatisfactory products, work or analysis
• A written contract should clearly describe
• Each party's duties and responsibilities
  including audits
• Clearly state how the authorized person, when
  exercising his or her full responsibility,
  releases each batch or issues certificate of
  analysis

7.1