Cleaning and Disinfection Program for Manufacturing Facilities

Description

Understand the critical steps to developing and validating a complete contamination control program within controlled and non-controlled environments! This training course will also identify and describe systematic elements essential to assuring an appropriate and compliant contamination control program for aseptic manufacturing facilities, classified and non-classified environments. With the Health Canada’s risk-based regulatory initiatives focusing new attention on the risks of cross-contamination understanding lifecycle management techniques for an effective cleaning validation program is paramount. Cleaning of equipment is an essential GMP activity in avoiding and reducing the risk of contamination and cross-contamination. The cleaning and its validation approach have evolved over time with the implementation of Quality Risk Management principles. Residues of products and excipients, as well as of detergents, are increasingly an issue in inspections and audits. This training course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including  FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.

Training Objectives

• Identify and characterize potential residues including product, processing aids, cleaning agents, and adventitious agents
• Apply appropriate analytical methodology for selected residues
• Determine suitable sampling techniques and the selection of sampling locations that present a challenge for the cleaning process
• Calculate residue limits that meet all necessary regulatory requirements
• Create scientifically sound rationales, validation protocols, and reports
• Manage the challenges of multi-product facilities in the establishment of limits, determination of validation strategies, and maintaining the validated state
• Understand campaign-based production strategies for effective and scientifically sound validation
• Differentiate the requirements for cleaning validation when using manual, semi-automatic, and automatic cleaning technologies
• Determine scientific grouping or bracketing approaches
• Comprehend the pitfalls inherent in cleaning after the production of biopharmaceutical and pharmaceutical products
• Accomplish analytical method validation and recovery study requirements in cost-effective studies that provide the necessary assurance of an analytical system
• Evaluate cleaning practices, limit calculations, scientific rationales, and validation documents through internal self-audits to ensure compliance with ever-changing regulatory needs
• Practice hands-on exercises designed to reinforce core competencies and job-focused skills

Why Should you attend

• Elements of a cleaning validation program from start to finish
• Exploring such concepts as the determination of residues to be targeted
• Selection of analytical and sampling methods
• Determination of appropriate limits in various pharmaceutical and biotechnology processes
• Establishment of scientific rationales acceptable to regulatory inspectors
• For mature cleaning validation programs, concepts such as understanding process control, capability
• Learning to effectively self-audit a cleaning validation program and documentation

Training Content

• Regulatory Requirements for Cleaning Validation
• Goals of Cleaning: Risk and Science
• Basic Microbiology and Environmental Monitoring
• Cleaning design and processes.
• Type and selection of cleaners, Soil residue evaluations. Determination of the critical parameter
• Designing Disinfectant Validation
• In Situation Testing and Start Up
• Contamination Control Strategy (CCS)
• Acceptance criteria (based on PDE (Permitted Daily Exposure)
• Equipment grouping
• Product grouping
• Cleaning methods: CIP, manual cleaning
• Design/Commissioning CIP aspects: Coverage test, dismantling
• Sampling selection based on a risk-based assessment, type of sampling (rinse vs swabs)
• Hold time studies: DHT, CHT
• CV execution and CV Revalidation
• Method Validation and Recovery Studies
• Documentation for Cleaning Validation
• Risk Review and Risk Communication

Who Should Attend

• Professionals responsible for all aspects of cleaning validation programs, including development, deployment, and maintenance
• Quality assurance specialists, quality control technicians, regulatory affairs professionals, pharmacologists and toxicologists, validation scientists, and validation service personnel
• Manufacturing supervisors, technical support personnel, and engineers responsible for evaluating cleaning systems, reviewing equipment, and supporting the cleaning validation program on the plant floor
• All levels of management who need to understand the science of cleaning and cleaning validation including the aspects of residue selection, sampling method and analytical detection method validation, limits determination, and strategies for managing multi-product facilities

Education approach

• Lecture sessions are illustrated with examples based on case studies
• Practical exercises include examples and discussions

Speaker

Kossi Molley, Chemist, LSSBB, PMP, Certified Trainer