This document discusses vendor audits for packaging materials. It defines a vendor audit as a way for pharmaceutical companies to inspect and evaluate a vendor's quality management system and practices. The objectives of a vendor audit are to ensure contracts are executed properly and identify risks, cost savings, and process improvements. The document outlines key steps in conducting a vendor audit, including preparing an audit plan, inspecting facilities and documentation, and writing an evaluation report. It also provides details on auditing packaging material vendors, such as checking storage areas, materials, and supplier qualifications.

1. PACKAGING MATERIAL
VENDOR AUDIT
PRESENTER
RAVICHANDRA NADAGOUDA
NH0120008
PHARMACEUTICAL QUALITY ASSURANCE

2. Contents
• Introduction to vendor audit
• Packaging material vendor audit
• Vendor audit checklist
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3. WHAT IS VENDOR AUDIT ?
A vendor audit is a vehicle used by pharmaceutical companies,
and other large companies as well, to inspect and evaluate a
vendor’s quality management system, as well as its practices,
products, and documentation.
The need to conduct vendor audits stems from a higher need
for quality control in an industry that needs to be more
regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve
quality control
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4. Objective of Vendor Audit
• The objective of vendor audit is to develop an audit function
comprising of qualified resources to effectively perform
compliance audits to ensure that the contracts are being
executed in accordance with the intent and address the net
benefit to include cost recoveries, process improvement
savings, fraud improvement and identification of hidden risks.
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5. Vendor Audit
• In order to reduce the cost pharmaceutical companies have
increasingly become dependent on their supplier/ out sourcing
partners for customer success. Though it has drastically reduced the
production cost for companies, there is a heightened supplier risk
and lack of visibility into supplier processes.
• To gain an insight into supplier process and eliminate the risks, FDA
encourages companies to conduct GMP supplier audit at the
manufacturing premises of the supplier.
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6. Vendor Audit
• According to GMP code, it is sole responsibility of pharmaceutical
industry to ensure that the suppliers manufacturing process,
analytical tests and examinations are carried out reliably by the
supplier and are in compliances with the applicable standards and
regulations.
• After the audit supplier must provide an appropriate corrective
action plan with measures that that will be implemented by the
supplier within a defined time frame to the manufacturer.
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7. Benefits of Vendor Audit
• Cost saving
• Process improvement
• Risk reduction
• Relationship building
• Helps management to achieve objectives
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8. Supplier Audit Checklist
1) Quality Policy
Looking into the details of supplier’s quality systems should be
utmost priority during a GMP supplier audit. Focus on
identifying the non-conformances in quality process,
production, packaging process, engineering changes,
shipment and invoicing at the vendor’s site.
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9. Supplier Audit Checklist
2)Training and Accountability
All the high quality machines, processes and tests may well go
down the drain if the vendor’s workforce is not fully prepared to
implement them. Make it mandatory that the supplier has
appropriate training program for new employees to meet the current
GMP quality requirements. Accountability is the key if you want the
supplier to maintain integrity and consistency. If management
comes forward to own the responsibilities for routine issues,
employees will be encouraged to perform their parts in a dedicated
manner.
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10. Supplier Audit Checklist
3)General Organization
A well-organized and clean manufacturing facility reduces the
chances of hazards and contamination. By auditing the
vendor’s workplace, you can have a fair idea of how seriously
the employees take their work. Do they pay attention to
details? Organizational culture in the workplace apprises you of
various facets of the supplier and may improve your confidence
in them.
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11. Supplier Audit Checklist
4)Supply Access
Your suppliers also rely on other suppliers for raw materials to
manufacture goods for you. When conducting a GMP supplier
audit, evaluate your supplier’s access to various supplies.
Because if your vendor fails to get an item from his supplier,
eventually you will not get your product on time.
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12. Steps-by-Step Guide to GMP Supplier Audit
Supplier auditing is a necessary part of quality management system.
Before signing a deal with a new supplier, you should conduct a thorough
GMP supplier audit to ensure that the supplier always delivers high quality
and standard products.
Follow are the steps to successfully perform the GMP supplier audit
1 - Schedule a time for audit by contacting the supplier. Observe how they
respond to your proposal of performing supplier audit. Allow them certain
time for preparation; it would benefit both the parties. Inform the vendor
on who the lead auditor will be and what resources would be required.
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13. 2 - Prepare the outline of your audit plan and review the vendor’s
performance history. Generally, audit plan depends on reason behind
conducting supplier audit. For example, if a discrepancy has been
reported in the production area, you should spend more time evaluating
it.
3 - Conduct the audit as scheduled, at the same time keep the supplier’s
schedule in mind. Their activities shouldn’t be hindered. Take a note of
how the supplier’s team welcomes and greets you because this reflects
the ethics and principles of the vendor.
4 - Take an inspection tour to the manufacturing premises, have a close
look at the equipment's and safety issues, pay attention to the GMP
operations and waste disposal. Do not miss the supplier’s shipping
policies, workforce strength and attitude of managerial as well as non-
managerial staff.
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14. 5 - Check the supplier’s invoices to know if they are charging you
accurately. There should be no inconsistencies in unexplained
miscellaneous charges, shipping and transportation fees. Keep
taking notes throughout the process. It will help you when writing
evaluation report and addressing the issues.
6 - Write down the complete evaluation report and support your
points with evidences. These documents should be accompanied
by your recommendation to resolve the issues. Discuss these
with the supplier’s team because they may also have certain
concerns.
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15. PACKAGING MATERIALS VENDOR AUDIT
Main goals
1. Perform a packaging component supplier audit.
2. Understand which worldwide requirements apply to
packaging component suppliers.
3. Use a range of information tools.
4. Recognize compliance or non-compliance with regulations
pertaining to packaging component supplier’s requirements.
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17. Key Parameters of a Packaging Component
Audit
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.
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18. Key Parameters of a Packaging Component
Audit
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.
STORAGE AREAS & PACKAGING MATERIALS
• Are all chemicals (pesticides, sanitizers, detergents, lubricants, etc.) stored securely, safely and
are they labeled correctly?
• Is packaging stored to prevent cross contamination?
• Are rejected or on hold materials clearly identified and separated from other materials?
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28. PROCEDURE FOR INCLUSION OF VENDOR IN
APPROVED VENDOR LIST (PACKAGING
MATERIAL)
New vendors must be qualified and approved by QA department before regular
supply of packaging materials in following manner :-
(1). Purchase department will locate the new vendor and find out the details of
products manufactured / supplied by them. In case of existing materials, Purchase
department will provide our specification to the new vendor.
(2). For printed and primary packaging materials, vendor audit is performed by
representative of Purchase department, QA department.
(3). Samples of printed packaging materials if necessary will be submitted to QA
department for evaluation.
(4). Purchase department after studying the comments of QA department shall
inform the supplier for the supply of the material manufactured by them.
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29. (5). Purchase department shall carefully study the quality aspect and also the
quantity and financial aspects of the vendor, they are as follows;
• Capability of the vendor to supply the required material within the specified period.
• Delivery schedule in order not to affect the production cycle.
(6). Based on the product compliance and assessment, further procurement of
packaging material should be continued.
(7). All the suppliers evaluated by R&D department on the basis of process / product
development parameters shall be considered as temporary vendors and will be
included in temporary approved vendor list.
Based on the commercial production supply, they will be transferred to approved
vendor list and shall be considered as permanent approved vendors.
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30. REFERENCE
• Review on vendor audit by Gaikwad Priyanka Hireman, Anil
Jadhav, Vasim Pathan, Nayan n.
• Overview of vendor audit by Salman Yasin
• Vallabh Vidhyanagar, Gujarat, India Vendor qualification for pharmaceutical excipients
– GMP requirements and approach K. T. Patel1, N.P. Chotai
• https://www.gmp7.com/blog/gmpsupplier-audit/
• www.civilserviceindia.com/subject/Management/notes/vendor-evaluation-and-audit
• www.expertbriefings.com/tips/what-you-need-to-know-about-vendor-audits
• www.authorstream.com/Presentation/rajeshgoud56-1925078-supplier-audit
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