Engineering is the backbone of successful design, installation, and maintenance of manufacturing. Commissioning, Qualification, and Validation (CQV) in pharmaceutical and medical device industries define a detailed and science-based process for the specification, design, and verification of new equipment or systems into a production pipeline. CQV engineers are necessary to launch a new or significantly modified project, as well as discrete instances of equipment qualification through installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ). In a large, highly-regulated industry operation, CQV can be a daunting task. The FDA has shifted its focus to emphasize risk-based approaches to meet regulatory standards. PSC Biotech® CQV engineers with over 20 years of experience have put together this series of blogs to prioritize risk management in CQV operations.
In this article, we focus on an overall CQV instance involving the launch of a new or significantly modified product rather than focusing on a discrete instance of equipment qualification (IQ/OQ/PQ). We outline the chief regulatory guidelines in the pharmaceutical and medical device industries and the assessments you need at hand to develop the Validation Master Plan.
How do you apply risk management to the commissioning and qualification of quality systems at a manufacturing site? This blog offers the steps you need to take for each system involved with the change and how to tackle a multi-system project.
Risk assessment is a crucial competency for modern pharmaceutical and biomedical manufacturing organizations. The objective of any risk assessment is to identify, analyze and evaluate potential risk. The ICH Q9 “Quality Risk Management” guideline defines the risk assessment principle as, “The evaluation of the risk to quality should be based on scientific knowledge and ultimately linked to the protection of the patient”. This PSC Biotech® post lists the standard formal risk assessment methods and their appropriate use.
This blog article discusses the identification and verification of “Critical Aspects” (as referred to by ASTM E2500) of pharmaceutical and biopharmaceutical manufacturing systems and facilities. What are critical aspects? How are the critical aspects of manufacturing systems identified? This blog answers these questions and outlines the design, verification, and validation of critical aspects of pharmaceutical facilities and equipment.
The FDA 2011 Guidance for Industry – Process Validation: General Principles and Practices established a three-stage “lifecycle” approach to achieving and maintaining a validated state. Specification, design, delivery, and installation are part of the lifecycle, as is verification, or Commissioning and Qualification (C&Q). What is the order of CQV that you need to follow? This blog discusses where C&Q fits into the validation lifecycle and what that means for quality risk management.
In the final installment of this series, we detail how to apply these principles and best practices on the floor and at the bench. This White Paper applies QRM principles to facility operations in the pharmaceutical industry. Update your Commissioning, Qualification and Validation principles to a science- and risk-based management. Download this whitepaper today!
Table of Contents
- QRM: Beyond Qualification and Validation
- Applicability of QRM Concepts to a Site PQS
- Evaluating the Quality Impact of Legacy Systems/Functions
- Identification of Critical Aspects
- Change Control According to Quality Impact
- Calibration of Instruments
- Preventative Maintenance
- Periodic Review and Requalification of Legacy Systems
- About the Author
- CQV Outsourcing
PSC Biotech® provides engineering support and CQV services.
PSC Biotech® is one of the largest providers for Commissioning, Qualification, and Validation services for the life science industry, with emphasis on Quality Risk Management. Our team consists of seasoned experts in the validation of facilities, utilities, equipment, computer systems, processes, cleaning, and test methods. We provide end to end solutions with expertise in Project Planning, CQV Master Planning, Requirement Specifications, Risk Assessments, Commissioning, Decommissioning, FATs, SATs, Installation Qualifications, Operational Qualifications, Performance Qualifications, Summary Reports, Traceability Matrixes, Calibration, Temperature/Humidity Mapping Services and more.
Our team of engineers efficiently completed the tasks of performing qualifications for the AQUATHERM SWS sterilizer (Syntegon). These tasks included writing and executing a Cycle Development Plan, an Installation and Operation Qualification (IOQ), and a Performance Qualification (PQ). PSC Biotech® continues to remain engaged with the client for continued support, as well as any future equipment qualifications to establish GMP regulations throughout the entire manufacturing facility.
PSC® has been providing engineering and validation services at the San Dimas facility since 2014. When the La Verne facility startup projects began, PSC® has been providing validation support to keep the facility operational. PSC® covers all aspects of facilities, utilities and process equipment qualification and validation across the entire facility.
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