In-house Compliance Workshop

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Compliance Workshop 104

(Current) Good Manufacturing Practices

Introduction, Requirements and Tools for Implementation

Course objectives

• Get a thorough understanding of FDA and international GMP regulations
• Learn how to effectively implement GMP in their groups and departments
• Understand consequences of non-compliance

Contents Overview

• FDA and International GMP regulations
• Difference between GMP and non-GMP work
• Organizational requirements
• Requirements for building and facilities
• Requirements for equipment and computer systems
• Requirements for packaging and labeling
• Responsibilities: Management, QA, all employees
  Required standard operating procedures
• Data generation and evaluation: raw data, intermediate results, final results
• Records keeping: format, length of time, archiving and reprocessing
  Preparing for GMP inspections

Detailed Agenda

FDA and International GMP Regulations

• FDA 21 CFR 210 and 211: history, objectives, scope
• International GMP regulations and guidelines: EU, WHO, PIC/S
• The increasing roles of ICH for APIs (Q7A) and finished drugs
• Who has to comply with which regulation and guideline
• GMP vs. GLP and Good Clinical Practices
• Inspection practices and enforcement
• Examples of FDA warning letters
• Key contents of GMP regulations
  

Organizational requirements

• Organizational structure
• Responsibilities: Management, QA, staff
• The unique roles of the QCU and the 'Responsible person'
• Requirement for the 'Responsible Person' in Europe
• Involvement of personnel in QC laboratories, production, IT/IS, documentation
• The role and certification of consultants
• Responsibilities and management of subcontractors
  

People, Equipment, Facilities, Containers

• People qualification: education, experience, training
• Documenting evidence of successful trainings, certification of employees
• Equipment qualification
• Software and computer system validation
• The validation/qualification lifecycle, steps and documentation
• Facilities: size, access, construction
• Control of components, containers, closures

Process control, packaging and distribution, product recalls

• Procedures for production and process control
• Procedures for receipt, identification, storage, handling, sampling, examination and/or testing of labeling and packaging materials
• Storage: quarantine, environmental conditions
• Product labeling, verification of label accuracy
• Distribution of products
• Product recalls: what, when, how
• Handling returned and salvaged products

Laboratory controls

• Sampling and sample handling
• Validation of analytical methods
• System suitability testing
• Setting test specifications and testing
• Review and approval of test results
• Documenting of sampling and test procedures
• Managing out-out-specification test results, failure investigations, and corrective and preventive action plans
• Stability testing
  

Management of raw data and other records

• Definition of raw data
• Acquisition and recording of raw data
• Maintenance and integrity of raw data
• The importance of 21 CFR Part 11 for electronic records
• Archiving: what, how long, how
• How to choose the archiving format: paper vs. electronic
  

Documentation

• Overview of required documents
• The documentation pyramid
• Which documents need to be reviewed, approved, signed?
• Developing, distribution and maintenance of SOPs
• Developing test scripts and protocols
• Annual product reviews Electronic vs. paper documentation
• The benefit electronic document management systems
  

GMP Inspections and Enforcement

• FDA's GMP inspection program
• 'Routine' vs. 'For Cause' inspections
• FDA's inspections abroad
• The value of FDA's pharmaceutical GMP inspection manual
• Inspections of sub-contractors
• Inspection observations and enforcement: 483s, EIRs, warning lettersPreparing for successful FDA and international GMP inspections through internal audits
  

Workshop Exercises

• Establishing an org. chart for GMP
• Development of a training plan
• List of validation tasks and associated deliverables along the equipment and computer system life. What needs to be done and documented when?
• Review and approval of test results
• Definition of raw data for combined electronic/paper based systems
• From a prepared list of documents attendees will select the ones that need to be be maintained
• Going through example documentation for computer system validation
• Attendees will be presented several FDA GMP Warning letters. Attendees will suggest responses and preventive and corrective actions.

10+ Reference documents for easy Implementation

The documents can be downloaded from a dedicated seminar website.
They include (for examples, see the end of this page):

• Primer: Good Laboratory Practices and Current Good Manufacturing Practices,120 pages
• Gap Analysis/Checklist: Good Laboratory Practice Regulations
• Worksheet: Laboratory audits
• SOP: Recording of GMP Raw Data
• SOP: Archiving GMP Data and Other Documents
• SOP: Generation and Maintenance of SOPs
• SOP: Facilities and Environmental Control
• SOP: FDA inspections - Preparation, Conduct, Follow-up
• SOP: Handling Deviations from Standard Operating Procedures
• SOP: Training for GxP, 21 CFR Part 11 and Computer Validation
• SOP: Retention and Archiving of Electronic Records
• SOP for EMEA GMP Inspections
• FDA Warning Letters and inspectional observations related to GMP
  

Who should attend

• Manufacturing supervisors and personnel
• Lab Supervisors and Managers
• QA managers and personnel
• GMP auditors
• IT managers and personnel
• Regulatory submission groups
• Documentation department
• Training departments
• Consultants
• Teachers

About the speaker: Dr. Ludwig Huber

• Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
• Team and/or review member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Equipment
• Presenter of the Year of the Institute for Validation and Technology
  Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues.
• Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press
• For more information on Ludwig Huber, click here.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.