change management/control

Question 1

Explain the Change Control/ Change Management system

Answer 1

• Unplanned change – unexpected and requires immediate action
• Planned change – exceuted with proper planning and a scheduled time.

Minor – impacts part of the process without affecting the characrteristics of the final product.
Major – affects the cGMP characteristics of the product, process, facility
Critical – can seriously impact the product causing its to fail In delivering the characteristic to the end-use

Question 2

importance of change control/management

Answer 2

• (pac)
  To prevent unwanted changes to validated processes, procedures, methods, equipment, documents, and facilities.
• › To create a structured procedure to assure changes will not adversely impact product quality, safety, identity, or purity of drug products.
• › To prevent unauthorized changes
• › To assure changes are correctly implemented and compliant with GMP requirements
• › Change control is not department-specific, rather the task of the whole company.