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Biacore G × P Services
Laboratories involved in pharmaceutical drug development
and manufacturing must satisfy the G × P (GLP, GCP, GMP)
regulations. Computer-controlled analytical systems
used in G × P applications must be validated and properly
maintained. Failure to comply with regulatory demands
is not a viable option from either a safety or economic
standpoint.
Validation is the process of establishing documented
evidence of control and is absolutely necessary for gaining
product approval. Computer system validation ensures
that:
• Hardware and software function as designed
• The process is controlled at all stages
• Data are processed as intended
Security of electronic records
21 CFR Part 11 from the U.S. FDA applies to all new and
existing systems. Protecting the security and integrity of
electronic records is essential for compliance with the Rule.
This includes ensuring the reliability and trustworthiness of
electronic records used to support critical decisions, such
as:
• Release of a production batch
• Pre-clinical and clinical trials
Validation lifecycle model
Key issues in complying with Part 11 are:
• Validation of system
• Accurate, complete copies
• Protection of records
• Limiting system access
• Audit trails
• Authority checks
A validation life cycle model is applied to keep a system in
a validated state during the entire product life cycle.
Qualification in the G × P laboratory
User
Requirements
Performance
Qualification
Functional
Requirements
Operational
Qualification
Detailed
Design
Installation
Qualification
The validation life cycle ensures adequate validation of computerized
systems.
Qualifications should only be conducted by GMP trained
and experienced personnel. To ensure that the system is
maintained in a validated state, periodic maintenance,
calibrations, and re-qualifications are mandatory
requirements.
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Label-free interaction analysis
Develop
System
Equipment Qualification is the overall process of ensuring
that a system performs according to specifications agreed
by the user and vendor. It is commonly broken down into:
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
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