Regulatory Requirements for Sampling Procedures
- API and finished goods sampling
- Regulatory requirements
- EU GMP Part 1, Chapters 4, 5, 6
- EU GMP Part 2, Chapter 7
- EU GMP Chapter 4
- EU GMP Annex 8
- EU GMP Annex 19
- Other regulations
- US / FDA Requirements
- WHO - PIC/S - ISO 2859-1 (former Military Standard)
- Supplier qualification and audits
Design and Qualification of Sampling Areas for Incoming Goods Products
- Sampling area for raw materials, APIs and excipients
- Layout and design of premises and equipment
- “Cleanroom”-like classification?
- What are the appropriate environmental requirements for sampling areas?
- How to qualify and maintain sampling areas?
- Is a change of pallets/removal of cart boxes required?
- Are expectations increasing? - Lessons learned during inspections
Supplier Qualification and Supply Chain Traceability: an important Prerequisite for Reduced Sampling and Reduced Testing
- Qualification of packaging materials
- Qualification of APIs and excipients
- Supplier qualification / Supplier audits
- Quality Agreements
- Specifications / Pharmacopoeial monographs / Supplier CoA
- Complaint Handling
Sampling and Documentation to make the Supplier liable for Defect Products
- Legal and Contractual Liability
- Definition of a Product Defect
- Express Warranty
- Admissible Evidence
Case Study I: How to Define Inspection Procedures for Packaging Materials (Primary and Secondary) in the Incoming Goods Control
- Sampling Plans for printed packaging materials, glass containers, plastic containers, etc.
- AQL (Acceptable Quality Level)
- Tests required according to Ph.Eur. / USP
- Options for reduced sampling
- Options for reduced testing
- Skip lot testing
Case Study II: How to Define and Optimise Sampling and Testing Procedures for APIs and Excipients in the Incoming Goods Control
- Sampling of APIs and excipients
- Risk assessment and rational for different sampling plans and sampling procedures
- Options for reduced ID testing
- Options for reducing analytical costs (economic order size and accepting CoA from suppliers)
- Optimization of ID testing using NIR/RAMAN
How to Deal with Divergent Compendial Method Requirements
- ICH QB4 and the Pharmacopoeial Discussion Group
- Divergent and conflicting pharmacopoeial requirements
- CDER’s MAPP 5310.7 “Acceptability of Standards from Alternative Compendia”
- How to proceed in case of missing harmonization?
- How to proof equivalence?
Parallel Sessions: Working on specific Tasks
1. Strategies/Prerequisites for Reduced Testing /Reduced Sampling
- The aim of this workshop is to evaluate in small discussion groups how the opportunities and requirements of EU GMP Chapter 5, Annex 8 and 21 CFR Parts 211 should be implemented in QA / QC.
2. Reduced Testing / Reduced Sampling for APIs / Excipients
- Participants will discuss and calculate benefits of different measures in small groups. Scenarios of different materials / suppliers / qualification status, use of NIR/RAMAN for identity testing and optimization of the order size to reduce testing effort will be evaluated including their impact on the sampling and testing plans for APIs and excipients.
3. Reduced Testing / Reduced Sampling for Primary and Secondary Packaging Materials
- Participants will discuss in small groups scenarios of different materials / suppliers / qualification status / etc. and their impact on the sampling and testing plans with regard to reduced sampling and reduced testing for packaging.