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Vendor Audites

bulk Pharmaceutical and packaging material vendor audit

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3/27/2018
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3/27/2018 2
INTRODUCTION:
Manufacture of Medicinal Products and the Active
Pharmaceutical Ingredients (APIs) , Bulk Pharmaceutical Ingredients
(BPIs) used as starting materials in the production of these products
is subject to strict good manufacturing practice regulations that are
designed to ensure their quality, safety and efficacy. This ensures
that patients worldwide and at any time can have confidence in the
quality, safety and efficacy of medicines.
3/27/2018 3
The quality system requirements to identify, select, approve and
qualify vendors of all materials used in the manufacture of BPIs
and medicinal products are clearly defined in the GMP Guidelines.
CONTINEUED……
In addition to GMP regulatory the excipient vendor qualification is
particularly Important
To provide adequate assurance of drug product performance.
to avoid the potential risks mentioned below
• Presence of extraneous matter e.g., metal, paper, particles
• Cross contamination with other chemicals (either
excipients or APIs or breakdown products)
• Contamination with melamine risk materials
which is not permitted by legislation
• Inconsistent manufacture such that the quality of final
products cannot be assured
• mislabeling of containers leading to product mix-up
Concept of Quality by Design (QbD) involves understanding
of product variability in which contribution of excipient also needs
special consideration
3/27/2018 4
3/27/2018 5
Registered intermediates usually involve custom synthesis or
process development by the supplier.
The quality system requirements to identify, select, approve and qualify
suppliers of all materials used in the manufacture of APIs and medicinal
products are clearly defined in the GMP Guidelines.
BPI
3/27/2018 6
We are also referring to existing APIC guidance
documents whenever applicable to further clarify
expectations and provide consistency to the processes.
e.g.:
- Quality Agreements
- Auditing Guide,
- APIC Audit Programme
- APIC Quick Guide for BPI Sourcing
- APIC ICH Q7 How to do Document
- APIC Quality Management System Guide for BPI
manufacturers
Ad

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Vendor Audites

  • 2. 3/27/2018 2 INTRODUCTION: Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs) , Bulk Pharmaceutical Ingredients (BPIs) used as starting materials in the production of these products is subject to strict good manufacturing practice regulations that are designed to ensure their quality, safety and efficacy. This ensures that patients worldwide and at any time can have confidence in the quality, safety and efficacy of medicines.
  • 3. 3/27/2018 3 The quality system requirements to identify, select, approve and qualify vendors of all materials used in the manufacture of BPIs and medicinal products are clearly defined in the GMP Guidelines.
  • 4. CONTINEUED…… In addition to GMP regulatory the excipient vendor qualification is particularly Important To provide adequate assurance of drug product performance. to avoid the potential risks mentioned below • Presence of extraneous matter e.g., metal, paper, particles • Cross contamination with other chemicals (either excipients or APIs or breakdown products) • Contamination with melamine risk materials which is not permitted by legislation • Inconsistent manufacture such that the quality of final products cannot be assured • mislabeling of containers leading to product mix-up Concept of Quality by Design (QbD) involves understanding of product variability in which contribution of excipient also needs special consideration 3/27/2018 4
  • 5. 3/27/2018 5 Registered intermediates usually involve custom synthesis or process development by the supplier. The quality system requirements to identify, select, approve and qualify suppliers of all materials used in the manufacture of APIs and medicinal products are clearly defined in the GMP Guidelines. BPI
  • 6. 3/27/2018 6 We are also referring to existing APIC guidance documents whenever applicable to further clarify expectations and provide consistency to the processes. e.g.: - Quality Agreements - Auditing Guide, - APIC Audit Programme - APIC Quick Guide for BPI Sourcing - APIC ICH Q7 How to do Document - APIC Quality Management System Guide for BPI manufacturers
  • 7. 3/27/2018 7 Following different dimensions could be assessed: - Assurance of Supply, - Quality & Regulatory compliance; - Cost/Procurement aspects; - Technical/Innovation; - Communication capabilities & responsiveness
  • 12. 3/27/2018 12 • Perform a packaging component supplier audit. • Understand which worldwide requirements apply to packaging component suppliers. • Use a range of information tools, including the contents of this module, in support of a packaging component supplier audit. • Recognize compliance or non-compliance with regulations pertaining to packaging component supplier’s requirements.
  • 13. 3/27/2018 13 Packaging materials: Any material employed in the packaging of a medicinal product, excluding any other packaging used for transportation or shipment.
  • 15. 3/27/2018 15 Prior to the audit • Develop an understanding of the vendor manufacturing process specific to company requirements • Obtain a list of company components that are manufactured at the site. • Review recent rejections, complaints and issues, of the receiving site(s) and the respective statuses. • Review any Quality Agreements and relevant registration requirements. • Review compliance status of the site by checking for service history, recalls associated with the site, recent regulatory inspections (if applicable) and outcomes. • Review previous audit reports and actions During the audit • Perform a walk through of the manufacturing area. Ensure the production areas are clean and tidy. •Ensure the fabric is in good condition and appropriate design for control of the process.
  • 16. 3/27/2018 16  Line clearance  Contamination control  Validation and Qualification  Sampling  Documentation
  • 18. 3/27/2018 18 Vallabh Vidhyanagar, Gujarat, India Vendor qualification for pharmaceutical excipients – GMP requirements and approach K. T. Patel1, N. P. Chotai Production and Process Controls : Overview of CGMP Regulations and Regulatory Expectations Guidance for industry: supplier management drug office department of health PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE00910:Part I and Part II SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE December 2009 WHO Technical Report Series, No. 902, 2002 :Annex 9 Guidelines on packaging for pharmaceutical products