Lesson 5: BRITE Seminar: GMP II Jenae Williams Biogen Learning Consultant

Quality Control Function and Roles After today you should be able to: Explain the Function of Quality Control (QC) in a cGMP environment and the various roles within QC Discuss the impact of non compliance in various areas within a cGMP environment

Manufacturing Function and Roles Support Roles: Quality Assurance Function and Roles Corporate Quality Assurance Function and Roles Quality Control Function and Roles FUME Function and Roles Technology Development Function and Roles Regulatory Function and Roles Supply Chain Function and Roles Research and Development Function and Roles Medical and Clinical Research Function and Roles

QC Basic Regulatory Requirements: Quality Control Quality Control - is the Quality Units (laboratories) that perform all testing of the products (Chemistry, Microbiology, Virology, Bioassay etc) QC Basic Regulatory Requirements: Adequate laboratory facilities Trained personnel Approved procedures for: Sample management and sampling Inspecting and testing starting materials Packaging materials, intermediate, drug substance and drug product and finished goods Monitoring of environmental conditions

A functional Quality Control unit ensures GMP’s regarding Sampling Specifications and testing Documentation and release procedures

Quality Control Functional Components Sample Management Testing Contract Testing Laboratory Management Analytical Methods and Validation All Components of Quality Control Analytical Instruments and Validation Environmental and Utility Monitoring NEXT

Sample Management There must be a system of control for all samples which include: Sample Identification Receipt Chain of Custody Storage Destruction and Raw Data Management

Testing All sample testing is performed by Quality Control Analysts according to procedures Relevant test metods are performed according to procedure to ensures that material are not released for use, nor product released for sale until their quality has been judged to be satisfactory

Analytical Methods and Validation A system for validation of analytical methods is required Ensure that processes and methods consistently meet predetermined specifications and are suitable for intended use Periodically evaluate and revalidate systems, as necessary to provide assurance that the validated state is maintained

Analytical Instruments and Validation Maintain a system for the installation, validation, change control and implementation of Analytical Instruments Ensure that instruments consistently meet predetermined specifications and are suitable for intended use Periodically evaluate and revalidate systems for assurance that validated state is maintained

Environmental and Utility Monitoring An Environmental and Utility program verifies the suitability of environments and clean utilities for their intended use Alert/Action Levels are established for controlled environments and clean utilities Environmental Data is tracked, trended and reported

Contract Testing Lab Management Subject to External Audits An approved Quality Agreement is required for contract labs

Quality Control Unit Examples Examples of QC unit Areas: Sample Control Microbiology Virology Bioassay Chemistry Raw Materials Stability All responsible for performing testing to prove product SISPQ

QC Analyst Responsibilities Coordinate and preforms testing and review for analytical data to support release and stability of drug substance, drug product, and validation activities Authors or reviews controlled documentation, investigational protocols , reports, change control requests, validation protocols, validation reports, and exceptions reports per procedure May Lead the execution of method transfer, method development, method qualification, analytical improvement projects and validation of analytical methods

Quiz 1 Results

Next Week: FUME Function and Roles Debrief Attendance