Calibration and Qualification in Analytical Laboratories

Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.

For easy implementation, attendees will receive:

• 4 SOPs
  • User Requirement Specifications (URS) for analytical equipment
  • Change control for analytical equipment
  • Qualification of equipment
  • Allocating Analytical Instruments to USP <1058> Categories
• 20+ Examples for Instrument OQ Testing

• Lab equipment requirements for calibration and qualification
• Most common inspection problems
• USP Chapter <1058>: Analytical Instrument Qualification
• Development of an effective equipment qualification master plan
• Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
• Allocating equipment to qualification categories A, B and C
• Qualification and documentation requirements for each category
• Going through the category example list
• Approach for existing systems
• Approach for automated systems (incl. firmware/computer systems)
• Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
• Documentation requirements

• QA managers and personnel
• Analysts and lab managers
• Analysts
• QA managers and personnel
• Regulatory affairs
• Training departments
• Documentation department
• Consultans