One of the fundamental concepts of “current Good Manufacturing Practices” (cGMP) is that companies that manufacture and/or test medicines should be in a constant “State of Control”; in other words the medicines produced should have pure raw materials, appropriate equipment, cleanliness, trained personnel, accurate testing and everything documented from first to last.
This “State of Control” is achieved by having a set of Quality Systems that provide a documented context within which to manufacture and test drugs. In the late 1990’s the US FDA, the European Agencies and Japan began an effort to standardize regulator expectations for cGMP manufacturing. This culminated in a series of Quality Guidances under the banner of the International Conference on Harmonization (ICH). The ICH guidances that cover Quality aspects (listed Q1 through Q12) define the high level expectation for maintaining a State of Control.
This course will cover those ICH Guidances related to the Quality Systems for manufacturing:
- ICH-Q7: cGMPs for Active Pharmaceutical Ingredients
- ICH-Q8: Quality by Design for introducing new or generic products into manufacturing
- ICH-Q9: Risk Assessment and the role of assessing Risk in the development, manufacturing, testing and supply chain of drugs.
- ICH-Q10: Quality Management
- ICH-Q11: Development and Manufacture of Drug Substances
In addition certain aspects of the USFDA’s and EMA’s laws will also be covered:
- 21CFR210/211/820: US Code of Federal Regulations relating to drugs
- Eudralex & Annexes: EMA’s Rules for Governing Medicinal Products
As data integrity has become a “hot” topic and a frequent observation by regulators, one session will be devoted to Data Integrity in both manual and automated systems.
- 21CFR Part 11: Electronic Records & Electronic Signatures
- Annex 11: Computerized Systems
- MHRA Guidance on Data Integrity
US FDA, MHRA, EMA, Japan all have an extremely high expectation that manufacturers and testing labs who sell and/or test products for their markets will conform to the requirements for having a “State of Control”. This state will be evaluated by inspectors to determine that the Quality Systems are in place and that the Quality Management is able to maintain discipline and provide documentary evidence that a State of Control exists.
Inadequate Quality Systems and/or Quality Management are a guaranteed path to receiving an Import Alert, Warning Letter and/or EU Non-compliance Report.
A small investment to ensure the GMP workforce, especially Quality Unit Management, is fully in control of the Quality Systems is excellent insurance to avoid regulatory action that can have a negative market impact on the company and potentially huge cost for remediation.
In this two day workshop conference you will learn what global regulators expect for Quality Systems, Quality Management and a State of Control. During the workshop we will analyze case studies and perform class activities to better understand both theory and some practical approaches to Quality Management.
Learning Objectives:
Upon completing this course participants should:
- Understand the history and expectations for global regulators for Quality Management and a State of Control
- Understand the vocabulary Quality Management including expectations for a “Quality Culture”
- Understand aspects related to Quality Management from the following sources:
- ICH-Q7 GMPs
- ICH-Q8 Quality by Design for new and generic drugs
- ICH-Q9 Risk Management
- ICH-Q10 Pharmaceutical Quality System
- ICH-Q11 Development & Manufacture of Drug Substance
- 21CFR 210/211/820 for GMPs
- 21CFR 314 for Post Market Surveillance
- 21CFR Part 11 & Annex 11
- MHRA’s Guidance on Data Integrity
- Understand the role and importance of Documentation
- Understand the interaction and integration required for successful GMP operations
- How to prepare and present the State of Control to investigators during an inspection
Who will Benefit:
This course is designed for people throughout the GMP Operations with a focused emphasis on the Plant & Global Quality Units; Departmental Heads, Managers & Supervisors; and Plant Management. In addition, all GMP operations personnel could benefit, especially those selected SMEs within the organization who will face the inspectors.
Following personnel will benefit from the course:
- Executive Management
- Plant and Global Senior Quality Managers
- Plant and Global Quality Professionals
- Plant and Global Regulatory Professionals
- Plant and Global Compliance Professionals
- Production Managers, Supervisors and Operators
- Manufacturing Managers & Supervisors
- Warehouse Managers and Supervisors
- Calibration, Preventive Maintenance and Production Supervising Engineers
- Process and Department Owners
- Quality Engineers
- Quality Auditors
- Deviation & CAPA System Personnel
- Plant and Global Designated Investigators and Process Improvement Personnel
- Registration Process: 8:30 AM – 9:00 AM
- Introduction to a State of Control and Quality Systems
- What is a State of Control?
- Short History of Compliance, GMPs and Quality Systems
- Overview of ICH-Q7: GMP Quality Systems in conjunction with typical FDA inspection plan
- GMP Awareness Exercise
- Documentation & Record Keeping
- Why do we document?
- Difference between Documents and Records
- The Document Lifecycle
- Electronic Records
- Importance of Data Integrity and Good Documentation Practices (GDPs)
- Group Discussion Regarding Data Integrity
- Functional Documents
- SOPs & Work Instructions
- Batch Records
- Specifications
- Methods
- Other Key Functional Documents
- Quality Management
- Quality Review Board
- Training & Qualification of Personnel
- Annual Product Review
- Quality Metrics Reporting
- The Plant & Infrastructure
- Facilities and GMP Construction
- Water Systems
- Gas Systems
- HVAC
- Contamination Control
- Materials, Storage & the Supply Chain
- Specifications, Sampling & Testing
- Vendor / Supplier Qualification
- Material Handling
- Warehouse Segregation & Rejected/Returned Materials
- Shipping
- Manufacturing & Packaging Operations
- ICH-Q8: Process Parameters & Process Description
- ICH-Q11: Development and Manufacture of Drug Substances
- Equipment Selection & Use
- Calibration & Preventative Maintenance
- Contamination / Cross Contamination Control
- Material, Packaging & Label Controls
- Automation on the Shop Floor
- In Process Controls & CPPs
- The GMP Lab
- Lab Controls
- Lab Personnel Qualification
- Lab Instrumentation Controls & Qualification
- Test Methods and Method Qualification
- Data Management & the Certificate of Analysis (CoA)
- Chemicals, Reagents & Standards
- Environmental Monitoring & Media Fills
- Stability Program
- Maintaining the State of Control
- Risk Analysis and Impact Assessment
- Change Control
- Deviation & CAPA
- Internal Audits
- IPQA & Shop Floor Compliance
- Document Review
- Humans and Automated Systems
- Electronic System Compliance
- Warehouse Controls
- Pest Controls
- Post Market Surveillance: Complaints, Agency Alerts & Recalls
- Questions
Warford Reaney
Consultant and Mentor
Mr. Reaney has over twenty-five years’ experience in building, developing and managing teams to solve complex technical, regulatory, compliance and business challenges. His broad knowledge includes serving in Executive and Quality Management for multi-national corporations, biopharma start-ups and established pharmaceutical enterprises. Years of direct hands on involvement provide specific abilities to assist life science companies who serve or are entering the US/EU markets to achieve their technical, quality, product and financial goals within a context of good science and FDA / EU compliance. His frequent interaction with the USFDA enables him to assist manufacturers to meet the most current regulatory expectations.
Mr. Reaney has spent many years in India immersed in the diverse cultures and unique ways of business: As a teenager, he lived for several years with his parents in Hyderabad when his father worked for UNDP introducing technology for the nascent Indian Sponge Iron industry; after his university studies, he returned to India on a Fulbright Scholarship for two years; then in 2007, he and his wife moved to Indian and have been working with and mentoring Indian, US & EU companies who have operations in India and abroad for GMP manufacturing of API, OSD and Parenteral Formulations and for Biotech manufacturing.
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