GMP Laboratory Training - Pack of 7 Courses

Laboratory Controls – Anticipate the Systems Based FDA Inspection

Analytical Method Validation and Transfer

Agenda:

• Defining the Systems Based Inspection
• What are Lab Controls?
• FDA inspection techniques
• Why FDA switched to Systems based Inspections
• Preparing for a Laboratory Audit
• Training of analysts in proper inspection behavior
• Review of materials, equipment, tests and assays
• Inspection Expectations and Results / Real Life citations
• Responsibilities of QC / QA personnel during the audit
• Addressing observations or findings
• Real life citations

Agenda:

• Terminology defined: qualification, validation, revalidation and verification
• FDA, EMA, ICH requirements and guidance

Analytical Method Pre-Validation – Stage 1

• Analytical Target Profile (ATP)
• ICH Q8, Q9 and Q10 adherence – Pre-Validation Requirements

Analytical Method Validation Characteristics – Stage 2

• Specificity, accuracy, precision, linearity, range
• LOD and LOQ

Test Method Validation Protocol

• Elements of a validation protocol
• Pre-planning and planning steps

Test Method Validation Report

• Elements of the validation report
• Elements of the validation protocol and the associated final validation report

Auditing Laboratory Data Systems

Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance

Agenda:

• Categories of laboratory data system (GAMP)
• Lifecycle management, archiving and backup
• What counts as raw data?
• Protecting the integrity of analytical data
• General guidance on assigning user privileges
• Operating system configuration.
• Application configuration
• Controls appropriate for chromatography data systems
• Practices that aid compliance with data integrity requirements
• Examples from recent FDA warning letters

Agenda:

• Eight key FDA/EU requirements for integrity and security of laboratory data.
• How FDA inspectors check integrity and security of data.
• Most frequent security and integrity issues: going through recent 483’s, EIRs and warning letters?
• The importance of limited access to ‘individual users’ rather than to groups.
• FDA compliant definition, acquisition, maintenance and archiving of raw data.
• Critical integrity and security issues during the entire life of laboratory data: from  data acquisition through evaluation to archiving.
• Examples how to ensure and document data integrity.
• Documenting changes of laboratory data: paper, hybrid systems, electronic.
• The importance of electronic audit trail to document data integrity.
• Review of electronic audit trail: who, what, when and how.
• Ensuring timely availability through validated back-up and archiving.
• Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions.

Handling OOS Test Results and Completing Robust Investigations

Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries

Agenda:

• Definition Atypical or Out of Specification Result?
• Review of the FDA Guidance for Industry on Investigating OOS Test Results
  • Phase I: Initial Laboratory Investigation
  • Phase II: Full Scale Investigation
• Root Cause Analysis Methods
  • 5 Whys
  • Flow Charts
  • Checklists
  • Fishbone Diagrams

Session 2: Testing the hypotheses regarding potential root causes

• Retesting
• Considering Other Batches

Session 3: Developing a proper CAPA plan to address any Corrective Actions

• How to properly document findings
• Example of a proper OOS investigation write up

Agenda:

Session 1

• Introduction
• Quality Systems, Paradigm Shift, Global Perspectives
• QA/QC Validation
• Risk Assessment

Session 2

• Measurement, Resolution, Errors, and Uncertainty
• Regulatory and QS Requirements
• The Product Life Cycle Concept
• USP chapter 1058
• Examples of Various Systems

Session 3

• Strategies for Validation
• Documentation /Master Validation Plan

Session 4

• Training Requirements
• Examples of Various Systems

Establishing a Product Stability Testing Program

Agenda Part 1:

• Introduction of a Stability Testing Plan and Program
  • Applicable Regulation and Requirements
• General Stability Considerations Applicable to a New Product (i.e. Potency)
• Storage Conditions
  • Shelf Life Duration of Studies and Expiration Dates
  • Container Closure Requirements
• Sample Size
  • Sampling Plan
  • Handling and Analysis of Samples
• Stability Schedule (Suggested Schedules for Conducting Stability Studies)
  • Pre-approval and Post Approval Studies
  • Stability Tests
  • Reformulated Products
  • Accelerated Temperature Studies
  • Test Schedule Information
    • Suggested Time Points and Expiration Dates Based on Testing Time Points
    • Solid Dosage Forms Suggested Test Schedule
    • Liquid and Semi-solid Types Products Suggested Test Schedule
    • Reconstituted Products Suggested Test Schedule
  • Temperatures of Studies Based on the Product Type
    • Room Temperature Studies
    • Elevated Temperature
    • Refrigeration
    • Freezing Temperature
    • Special Humidity Considerations

Agenda Part 2:

• Analytical Testing Considerations
  • Quality Control Release Assays and Methods
  • Criticality of the Choice of Test that are Stability Indicators
    • Choice of Methods with Meaningful Data or Stability Indicator
  • Method Attributes
• Stability Testing Protocol Design
  • How to Design a Protocol and a Report
• Stability Testing Data Management and Trending
  • Trending Data
  • Expiration Dating Extrapolation Using Data
• Manual versus Automated Data Management
• Advantages and Disadvantages

You will also get answers to the following tough questions:

• For a medical device that has storage label of 15-30°C; Are stability studies at 15°C and 30°C or 25°C study sufficient?
• For a reconstitution study; product has an assigned expiration of 24 months; do I need to do reconstitution at 12 months (6, hours, 12 hours and 24 hours) and at 24 months (6, hours, 12 hours and 24 hours)?
• What is the accelerated storage for a product with real time storage of -20°C±5C?
• Is it an industry’s practice to do study one year past expiration?
• If the regression predicts failure before product expiration, what is the next step to do in stability?