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Audit of vendors and Production department
The document outlines the importance of vendor audits in the pharmaceutical industry, emphasizing adherence to good manufacturing practice (GMP) regulations to ensure quality, safety, and efficacy of medicinal products. It highlights the need for thorough vendor qualification to mitigate risks associated with contamination and inconsistent manufacturing. Additionally, it references existing guidance documents to maintain consistency in quality management processes.
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Introduction to the presenter and the focus on auditing of vendors and production departments.
Details regarding the checklist for tablet processing, likely outlining steps or requirements for quality assurance.
Information related to the checklist for capsule production processes, emphasizing quality and compliance.
Checklist content focusing on sterile preparation processes, stressing the importance of maintaining sterility.
Introduces vendor auditing, highlighting GMP regulations and their role in ensuring product quality and efficacy.
Terms and APIC guidance documents that provide clarity and consistency in vendor auditing and quality management.
Checklist format for vendor auditing, continuing the discussion on requirements and processes involved in audits.
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Audit of vendors and Production department
- 1. Presented by:- PuneetNirmal M.Pharm 1st year Dept. of QUALITY ASSURANCE ISF COLLEGE OF PHARMACY Mobile: 8285841601 Website: - www.isfcp.org Auditing of Vendors and Production Department
- 2. 3/27/2018 Checklist for TabletProcess 2
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- 8. Checklist for SterilePreparation 8
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- 14. Vendor Audit INTRODUCTION: Manufacture ofMedicinal 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: Thequality 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 toGMP 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.. Weare 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
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- 19. Checklist For Auditingof Vendors: 19
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