The pharmaceutical industry establishes product quality from the time raw materials, components and services are provided to the manufacturer by their suppliers. A weakened link in the supply chain will therefore have the potential to negatively impact product safety, regulatory compliance and patient trust.
Regular audits of suppliers is an integral component of a well-developed pharmaceutical quality management system. Audits build confidence that all your suppliers within your supply chain meet Good Manufacturing Practice (GMP) requirements and maintain a high standard of product quality at all times.
This article provides information on how supplier audits help to enhance product quality, mitigate risk and support compliance within the pharmaceutical industry.
A non-compliant supplier can:
- Provide raw materials that are contaminated.
- Create batch failures and resulting expensive recalls.
- Result in regulatory citations/warnings from the FDA.
- Create interruptions in supply chain.
Supplier audits protect the quality of raw material supplied to pharmaceutical companies by ensuring that the materials supplied to manufacturers conform to the same specifications and that the manufacturers’ processes follow good manufacturing practices (GMPs) as set out in ICH Q10 and 21 CFR Part 210/211, respectively. Therefore, supplier audits serve as an additional level of vigilance beyond compliance with GMP and are a means for all of us to protect our business risk and help ensure that the products we purchase are reliable.
Examples of regulatory guidance include 21 CFR Part 211.84 of the U.S. Food and Drug Administration, which requires testing and approval of component parts, container and closure systems, as well as GMP Chapter 7 – Supplier qualification and technical agreement conditions; ICH quality guidelines (ICH Q10); and WHO Good Manufacturing Practice, which all provide guidance for ensuring ongoing supplier qualification, approval and continuous monitoring of supplier performance through audits.
An audit demonstrates that the manufacturer has verified that the supplier complies with all applicable regulations, policies and procedures and is maintained on an ongoing basis.
The following items are included in the qualification process:
Supplier Initial Evaluation: Review the supplier’s financial viability, experience and reputation
Supplier Questionnaire Review: Gather supplier input regarding the supplier’s operations, quality system and regulatory history.
On-Site Audit: Perform an In-Depth GMP and Quality System Audit.
Supplier Approval Decision: Approve supplier based on the outcome of the supplier audit or conditionally approve/reject the supplier.
Ongoing Monitoring of Supplier Performance: Monitor supplier performance with periodic audits and based on supplier performance and quality metric data.
The supplier qualification must be risk based, as critical suppliers (API, sterile packaging manufacturers etc.) require a greater degree of supplier qualification evaluation than non-critical suppliers.
Key steps of the planning process include:
Establishing the scope of the audit: Which aspects will be investigated like production, QC, documentation.
Building an auditor team: Consisting of experts in quality, production and technical fields.
Examining historical performance: In order to analyze complaint patterns, deviations and prior audit findings.
Creation of an inspection checklist: The checklist will be customized for the suppliers’ particular operation and product category.
Planning allows for a focused audit, which is an effective use of resources and determination as to whether the supplier meets both regulatory compliance and the business objectives.
Steps of supplier audit are:
Opening Meeting: Introduction to the audit team, objectives defined, audit schedule agreement and opening meeting are done initially.
Facility Walkthrough: Visit and observe manufacturing warehouse and lab areas of the supplier’s facility.
Audit Documents: Check SOPs, batch records, deviation records and validation records.
Employee Interviews: Through employee interviews know the understanding on GMP and quality.
Closing Meeting: Summarize audit findings and discuss follow-up actions.
Auditor should conduct audit with an objective and professionally. Its important auditors maintain focus on the facts instead of opinions. A risk-based approach to audit allows auditors to evaluate critical findings of the audit that could adversely affect the product quality.
Common findings during Supplier Audits include:
Audit findings are classified as:
Critical – Findings that have a direct impact on product quality or patient safety like potential for contamination.
Major – Findings that may affect compliance or process control like the absence of validation.
Minor – Findings that are isolated in nature and considered to have minimal impact like incomplete logbooks.
An audit report should include:
- Audit scope/date
- Audit team members
- Audit summary
- Audit detailed findings with classification
- Response and corrective action of supplier
Audit reports as well as the suppliers' action plans should be sent within 30 days from the date of the audit.
Effective CAPAs will include;
- a root cause analysis using 5 Whys, fishbone diagrams
- specific corrective actions
- preventative controls
- the final due dates and responsible people
- verification of the effectiveness of the corrective action plan
Manufacturers need to confirm all CAPA responses through review and approval and verify implementation via evidence and follow-up audits.
Continuous Supplier Monitoring includes various types of monitoring:
By maintaining a continual long-term view on supplier performance, we can identify potential problems before they escalate to a level that will require corrective actions.
It is important to encourage suppliers to communicate honestly during an audit process. Suppliers are more likely to make necessary operational improvements when they understand why it's important to be GMP compliant.
Joint training, technical assistance and collaborative activities are other ways to strengthen your partnership with suppliers. It will be a great move toward improving the supplier's products or services. When suppliers think of your audit program as working together, they become strategic partners for helping ensure the quality of your products.
Auditing suppliers has an essential role to play regarding the integrity and safety of the pharmaceutical product. Audits cover the needs of compliance, they also help to ensure a secure supply chain for manufacturers while providing protection from disproportionately expensive recalls and creating consumer confidence in the products they produce.
The methodology of risk-based planning, the proficiency of audit methodology and the follow-up auditing associated with proactive follow-up allow manufacturers to create a supplier network capable of providing a complete and consistent level of standards for both regulatory and quality compliance.
Quality is not achieved by having a single organization do its own. Quality is built collectively through the efforts of several organizations and suppliers to produce a final product that is delivered to patients. The audit process creates a direct link between each supplier and every other supplier to assure quality products delivered to patients through a commitment to excellence.
Regular audits of suppliers is an integral component of a well-developed pharmaceutical quality management system. Audits build confidence that all your suppliers within your supply chain meet Good Manufacturing Practice (GMP) requirements and maintain a high standard of product quality at all times.
1. Why Supplier Audits Matter
Pharmaceutical manufacturers allow suppliers for procurement of materials such as raw materials, excipients and packaging components. This system shows that a manufacturer’s finished product is influenced by each of their suppliers’ product quality.A non-compliant supplier can:
- Provide raw materials that are contaminated.
- Create batch failures and resulting expensive recalls.
- Result in regulatory citations/warnings from the FDA.
- Create interruptions in supply chain.
Supplier audits protect the quality of raw material supplied to pharmaceutical companies by ensuring that the materials supplied to manufacturers conform to the same specifications and that the manufacturers’ processes follow good manufacturing practices (GMPs) as set out in ICH Q10 and 21 CFR Part 210/211, respectively. Therefore, supplier audits serve as an additional level of vigilance beyond compliance with GMP and are a means for all of us to protect our business risk and help ensure that the products we purchase are reliable.
2. Regulatory Expectations for Supplier Audits
The expectation of regulatory bodies worldwide is that pharmaceutical companies are liable for the suppliers they use.Examples of regulatory guidance include 21 CFR Part 211.84 of the U.S. Food and Drug Administration, which requires testing and approval of component parts, container and closure systems, as well as GMP Chapter 7 – Supplier qualification and technical agreement conditions; ICH quality guidelines (ICH Q10); and WHO Good Manufacturing Practice, which all provide guidance for ensuring ongoing supplier qualification, approval and continuous monitoring of supplier performance through audits.
An audit demonstrates that the manufacturer has verified that the supplier complies with all applicable regulations, policies and procedures and is maintained on an ongoing basis.
3. The Supplier Qualification Process
Suppliers must meet certain criteria before being qualified to supply goods or services. A structured qualification process will verify that suppliers can consistently provide quality goods or services.The following items are included in the qualification process:
Supplier Initial Evaluation: Review the supplier’s financial viability, experience and reputation
Supplier Questionnaire Review: Gather supplier input regarding the supplier’s operations, quality system and regulatory history.
On-Site Audit: Perform an In-Depth GMP and Quality System Audit.
Supplier Approval Decision: Approve supplier based on the outcome of the supplier audit or conditionally approve/reject the supplier.
Ongoing Monitoring of Supplier Performance: Monitor supplier performance with periodic audits and based on supplier performance and quality metric data.
The supplier qualification must be risk based, as critical suppliers (API, sterile packaging manufacturers etc.) require a greater degree of supplier qualification evaluation than non-critical suppliers.
4. Planning the Supplier Audit
Planning is essential for success of an audit because it defines the audit's objectives, scope and methodology.Key steps of the planning process include:
Establishing the scope of the audit: Which aspects will be investigated like production, QC, documentation.
Building an auditor team: Consisting of experts in quality, production and technical fields.
Examining historical performance: In order to analyze complaint patterns, deviations and prior audit findings.
Creation of an inspection checklist: The checklist will be customized for the suppliers’ particular operation and product category.
Planning allows for a focused audit, which is an effective use of resources and determination as to whether the supplier meets both regulatory compliance and the business objectives.
5. Conducting the Audit
An audit of a supplier provides an opportunity to assess how that supplier operates by looking at records, talking to people and observing their physical environment. This can be accomplished through a variety of activities including.Steps of supplier audit are:
Opening Meeting: Introduction to the audit team, objectives defined, audit schedule agreement and opening meeting are done initially.
Facility Walkthrough: Visit and observe manufacturing warehouse and lab areas of the supplier’s facility.
Audit Documents: Check SOPs, batch records, deviation records and validation records.
Employee Interviews: Through employee interviews know the understanding on GMP and quality.
Closing Meeting: Summarize audit findings and discuss follow-up actions.
Auditor should conduct audit with an objective and professionally. Its important auditors maintain focus on the facts instead of opinions. A risk-based approach to audit allows auditors to evaluate critical findings of the audit that could adversely affect the product quality.
6. Common Findings During Supplier Audits
Supplier Audits reveal many areas where product quality and product compliance can be negatively affected. By knowing what the common findings are, manufacturers can expect those same types of issues when they audit suppliers and therefore avoid future issues arising from those same problems.Common findings during Supplier Audits include:
- Batch manufacturing record not complete
- Cleaning and analytical methods not validated
- Calibration and equipment maintenance incomplete
- Change control and deviation management incomplete
- Staff training and qualification inadequate
- Inadequate controls on data integrity
7. Evaluating and Reporting Audit Findings
Findings from an audit must be documented, classified and communicated.Audit findings are classified as:
Critical – Findings that have a direct impact on product quality or patient safety like potential for contamination.
Major – Findings that may affect compliance or process control like the absence of validation.
Minor – Findings that are isolated in nature and considered to have minimal impact like incomplete logbooks.
An audit report should include:
- Audit scope/date
- Audit team members
- Audit summary
- Audit detailed findings with classification
- Response and corrective action of supplier
Audit reports as well as the suppliers' action plans should be sent within 30 days from the date of the audit.
8. Corrective and Preventive Actions (CAPA)
To ensure that audits' conclusions bring about enhancements, vendors need to provide CAPA's that address audits' findings;Effective CAPAs will include;
- a root cause analysis using 5 Whys, fishbone diagrams
- specific corrective actions
- preventative controls
- the final due dates and responsible people
- verification of the effectiveness of the corrective action plan
Manufacturers need to confirm all CAPA responses through review and approval and verify implementation via evidence and follow-up audits.
9. Continuous Supplier Monitoring
Continually monitoring suppliers is an important activity in order to maintain supplier compliance and supplier performance after an initial supplier audit.Continuous Supplier Monitoring includes various types of monitoring:
- Regular audits annually or twice a year
- Certificates of analysis (COA) review, deviations and complaints review
- Supplier scorecards to evaluate delivery performance, quality performance and responsiveness.
- Trend data from incoming material inspections.
By maintaining a continual long-term view on supplier performance, we can identify potential problems before they escalate to a level that will require corrective actions.
10. Building Collaborative Supplier Relationships
Instead of looking supplier audits as a tool to find supplier fault, companies should use audits to develop a partnership. The purpose of an audit is to help both parties achieve the same quality objectives.It is important to encourage suppliers to communicate honestly during an audit process. Suppliers are more likely to make necessary operational improvements when they understand why it's important to be GMP compliant.
Joint training, technical assistance and collaborative activities are other ways to strengthen your partnership with suppliers. It will be a great move toward improving the supplier's products or services. When suppliers think of your audit program as working together, they become strategic partners for helping ensure the quality of your products.
Auditing suppliers has an essential role to play regarding the integrity and safety of the pharmaceutical product. Audits cover the needs of compliance, they also help to ensure a secure supply chain for manufacturers while providing protection from disproportionately expensive recalls and creating consumer confidence in the products they produce.
The methodology of risk-based planning, the proficiency of audit methodology and the follow-up auditing associated with proactive follow-up allow manufacturers to create a supplier network capable of providing a complete and consistent level of standards for both regulatory and quality compliance.
Quality is not achieved by having a single organization do its own. Quality is built collectively through the efforts of several organizations and suppliers to produce a final product that is delivered to patients. The audit process creates a direct link between each supplier and every other supplier to assure quality products delivered to patients through a commitment to excellence.
Frequently Asked Questions (FAQs) on Supplier Audits in Pharmaceuticals
Q1. What is the purpose of supplier audits in pharma?
Answer: Verifying compliance with GMP and consistent supply of quality materials & services from suppliers.Q2. When will supplier audits be performed?
Answer: Every one to three years depending on the risk involved with the supplier and performance history.Q3. Who will perform the audits?
Answer: Qualified auditors from the QA or compliance teams at the pharmaceutical company.Q4. What are common findings of a supplier audit?
Answer: Common supplier audit findings are inadequate documentation, lack of validation of processes and inadequate data integrity practices.Q5. Which regulations require supplier audits?
Answer: FDA 21 CFR, EU GMP Chapter 7, ICH Q10 all require that suppliers must be qualified.Q6. How do you manage supplier audit findings?
Answer: There should be a system for corrective actions, preventive actions and for verifying effectiveness of the corrective action plan (CAPA).Q7. Do audits improve relationships between pharma companies and suppliers?
Answer: Yes, audits help to establish commonality of quality expectation and a collaborative environment that fosters improvement.Q8. What is the ultimate intention of auditing suppliers?
Answer: To provide a supply chain for pharmaceuticals that is reliable, compliant and built upon a foundation of quality.
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