I. Review Background and History of Good Manufacturing Practices
Evaluate the law and regulations for GMPs
Define GMPs, common terms and acronyms
Comparative overview of different GMPs/QSRs
Exercise: Determine Participants’ Backgrounds and Experiences with GMPs
II. Classify GMP Practice Elements
Define the essential GMP elements
Identify the requirements for each GMP element
Identify targets for noncompliance
Exercise: Create a Comparison Matrix of GMP and QSR Requirements
III. Assess the Design of a GMP-Compliant System
Critique roles and responsibilities
define organizational and functional responsibilities
plant management and manufacturing staff
define QA/QC staff requirements
Author, manage and maintain SOPs
Maintain document control in compliance with Part 11
Assure control of change
Exercise: Review Case Studies and Examples of GMP-Compliant Systems
IV. Evaluate Proven Strategies for Implementing GMPs
Perform a pre-assessment audit and “gap analysis” to determine the state of GMP compliance
Develop a strategic plan/organization based on the pre-assessment
Implement training initiatives to maintain GMP compliance
V. Comply with GMP Requirements for Component Control and Warehousing
Analyze requirements for buildings, facilities and equipment
Establish control of components
develop incoming receipt to ensure total control of components
establish testing and laboratory controls
Implement GMP requirements for warehousing
VII. Maintain GMP Compliance for Storage and Distribution Operations
Determine requirements for holding and distribution
Identify how to handle returned goods
Establish methods and procedures for handling
Put controls in place to prevent mix-ups
Identify which records and reports to maintain and determine for how long
VIII. Apply Fundamentals of Validation to GMPs
Define validation and validation protocols
Perform process validation and test method validation
Determine what to validate
Identify impact on GMP elements
Exercise: Critique GMP Validation Methods
IX. Identify Current Regulatory Enforcement Trends
Determine requirements for efficient CAPA
Determine what triggers an inspection
Analyze the FDA’s new risk-based approach to inspecting drug manufacturers
Understand the inspection process and potential enforcement actions
18(hours)