CQV Process Validation

Keep Your Standards High with Process Validation Services from Transcat

Your manufacturing organization not only faces the challenges of moving quickly and maintaining uptime; it’s also highly regulated. Your processes must be consistent, reliable, and capable of unfailingly producing products that meet your high standard of quality. Process Validation Services from Transcat can help ensure that happens - and that you’re prepared to meet industry standards and overcome challenges as they arise

What is Manufacturing Process Validation?

Process validation is a systematic approach to ensuring a manufacturing process consistently produces a product of predetermined quality, and it’s a critical element of regulatory compliance.  

Proper process validation requires thoughtful planning and a comprehensive, detailed execution strategy encompassing process design, qualification, and continued verification. (FDA Guidance for Industry Process Validation: General Principles and Practices)

The Role of Process Validation in Driving Quality and Efficiency

Process Validation ensures manufacturing processes maintain high standards of quality and efficiency by:
  • Reducing the risk of product defects 
  • Minimizing deviations 
  • Preventing costly recalls 
  • Ensuring product safety by identifying potential risks and deviations  
  • Ensuring compliance with regulatory requirements such as the Food and Drug
  • Administration (FDA) and the European Medicines Agency (EMA). 
  • Proving that the manufacturing process is well-controlled and capable of
  • consistently producing high-quality products. 
  • Process validation also analyzes process data to identifying opportunities to increase efficiency, reduce waste, and improve overall performance. 

Working with Transcat: Inside Our Process Validation Services

Process Validation ensures manufacturing processes maintain high standards of quality and efficiency by:
  • Reducing the risk of product defects 
  • Minimizing deviations 
  • Preventing costly recalls 
  • Ensuring product safety by identifying potential risks and deviations  
  • Ensuring compliance with regulatory requirements such as the Food and Drug
  • Administration (FDA) and the European Medicines Agency (EMA). 
  • Proving that the manufacturing process is well-controlled and capable of
  • consistently producing high-quality products. 
  • Process validation also analyzes process data to identifying opportunities to increase efficiency, reduce waste, and improve overall performance. 
Process DesignProcess Design

Process Design 

Validation begins by designing and documenting the process in detail. Critical process parameters and the corresponding operating ranges are identified, while factors such as equipment, facilities, and personnel, are also considered. The process is then evaluated using risk assessment tools to identify potential areas of concern.

The Transcat team gains a thorough understanding of not only the technical specifications but also the potential impact of environmental and external factors on process performance. By carefully designing the process, the team will identify potential risks and challenges identified early on and implement mitigation strategies ahead of need.

Process design also involves selecting suitable equipment and facilities, and ensuring the personnel involved in the process have proper training and qualifications and the necessary skills and knowledge.

Process QualificationProcess Qualification

Process Qualification

Process Qualification involves executing validation protocols to verify the process performance and collecting data to support the validation.
During this stage, the team will ensure that the process meets the required standards through: 
  • Installation qualification (IQ): verifying that the equipment is installed correctly and according to the manufacturer's specifications and is in the proper condition to perform its intended functions. 
  • Operational qualification (OQ): ensuring that the equipment operates as intended and meets the predefined operating parameters. 
  • Performance qualification (PQ): the final step in the process qualification stage, this involves verifying that the process consistently produces products conforming to their predetermined specifications by collecting and analyzing data from multiple production runs to ensure that the process is stable and capable of meeting the required quality attributes. 
The process qualification stage is critical in establishing confidence and providing evidence that the process is capable of consistently producing high-quality products as designed.
Continued Process Verification Continued Process Verification

Continued Process Verification 

Process Verification focuses on ongoing monitoring and evaluation of process performance to ensure that it remains in control by collecting and analyzing data from routine production runs and making necessary adjustments to maintain its validated state. 

This provides valuable insights into the process's performance over time and identifies trends or deviations from the validated state so you can address risks proactively. 

How Process Validations Helps Companies Meet Regulatory Requirements for Process Validation

Meeting regulatory requirements is a critical step in process validation. The team at Transcat will work to ensure your products and processes meet the standards and requirements of regulatory bodies such as the FDA and the EMA, the EMA (European Medicines Agency.)

Discover how working with Transcat can help you meet industry requirements, maintain high standards of quality, and prevent challenges before they arise. 

Partnering with Transcat unlocks the potential to optimize efficiencies in your operations. Contact us today for a tailored solution for your unique needs.