Audit of vendors and Production department

PUNEET NIRMAL
PUNEET NIRMALAssistant Professor em Lloyd institute of management and technology (Pharm.)
Presented by:- Puneet Nirmal
M.Pharm 1st year
Dept. of QUALITY ASSURANCE
ISF COLLEGE OF PHARMACY
Mobile: 8285841601
Website: - www.isfcp.org
Auditing of Vendors and
Production Department
3/27/2018
Checklist for Tablet Process
2
3
4
Checklist for Capsule
5
6
7
Checklist for Sterile Preparation
8
9
10
11
12
13
Vendor Audit
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.
14
Why Vendor Audit:
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
15
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
16
Terms Which Followed..
We are also referring to existing APIC guidance documents
whenever applicable to further clarify expectations and provide
consistency to the processes. e.g.:
- QualityAgreements
- 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
17
18
Checklist For Auditing of Vendors:
19
Cont..
20
21
1 de 21

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Audit of vendors and Production department

  • 1. Presented by:- Puneet Nirmal M.Pharm 1st year Dept. of QUALITY ASSURANCE ISF COLLEGE OF PHARMACY Mobile: 8285841601 Website: - www.isfcp.org Auditing of Vendors and Production Department
  • 3. 3
  • 4. 4
  • 6. 6
  • 7. 7
  • 8. Checklist for Sterile Preparation 8
  • 9. 9
  • 10. 10
  • 11. 11
  • 12. 12
  • 13. 13
  • 14. Vendor Audit 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. 14
  • 15. Why Vendor Audit: 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 15
  • 16. 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 16
  • 17. Terms Which Followed.. We are also referring to existing APIC guidance documents whenever applicable to further clarify expectations and provide consistency to the processes. e.g.: - QualityAgreements - 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 17
  • 18. 18
  • 19. Checklist For Auditing of Vendors: 19
  • 21. 21