Incorporate Domestic and International Regulations for Effective GMP Auditing

Incorporate Domestic and
International Regulations
for Effective GMP Auditing
Janeen Santarosa
Regulatory (Affairs)
Specialist II

Presentation Overview
• Best Practices for harmonization
• Domestic and international guidances,
standards and regulations
• Integrating valuable risk based and
sustainable practices
• Supplier audit practice tools
Copyright Nelson Laboratories
2011
2

Harmonization Objectives
FDA’s goals in participating in international
harmonization include:
• To safeguard U.S. public health
• To assure that consumer protection standards and
requirements are met
• To facilitate the availability of safe and effective
products
• To develop and utilize product standards and other
requirements more effectively
• To minimize or eliminate inconsistent standards
internationally
2011
3

Benefits…
• We are ultimately responsible for assuring the
quality and compliance of our products.
• Aligning goals = reaching high levels of
performance without excessive costs or
redundant or conflicting requirements.
• Avoid the risk of service/product failures.
• Ensure specifications match supplier capabilities
to avoid issues.
• Supplier Benefit: Increased knowledge and better
understanding of customer expectations.
2011
4

Harmonized Requirements
• Comparison Chart outlining supplier qualification
• Similarities but with different applications
include:
• ICH-Manufacturers of intermediates and/or API’s should
have a system(s) in place for evaluating suppliers of
critical material. Materials should be purchased against
an agreed specification from supplier or suppliers
approved by the quality units.
• GHTF-When selecting potential suppliers the
manufacturer should investigate their business and
operational capability. Select potential suppliers
according to predefined criteria and the results of
capability investigations.
2011
5

Best Practices
• Developing a risk based sustainable approach
• Systems for managing and controlling
suppliers include:
• Qualification
• Audits (paper/onsite), third-party certification)
• Assessments (intervals)
• Agreements (quality/change)
• Monitoring (continuous)
2011
6

Audits
• Comparison Chart outlining supplier audits
include:
• GHTF - Depending on the risk of the supplied
product/service, the manufacturer may plan and
perform periodic supplier re-evaluations,
regardless of whether problems have been
identified.
• TGA - Period Review: As part of the qualification
process a program for Periodic Review should be
established.
2011 7

Audits
Base supplier audits on type of risk (e.g. service
provided, supplies purchased, third party
certifications).
Definitions:
• GHTF/SG4/N33 “critical supplier” is a supplier delivering materials,
components, or services that may influence the safety and
performance of the product.
• ICH Q7: “Critical describes a process step, process condition, test
requirement, or other relevant parameter or item that must be
controlled within predetermined criteria to ensure that the API
meets its specification”.
• ICH Q9: “Risk is the combination of the probability of occurrence of
harm and the severity of the harm to the patient or consumer”.
2011
8

Audits
• Rate supplier audits on risk-based process
approach.
• Risk level drives the relation of supply/supplier.
The level of action addresses the supplier
situation individually and provides measureable
controls around the supplier.
• Tailor internal resources: Identify supplier risk
during receipt inspection, QC verification,
in-process inspection and final inspection.
2011
9

Audits
Example of Risk Levels:
• Level 1: The highest risk suppliers that have a
critical impact on the quality or availability of your
product
• Level 2: Significant risk suppliers that have a direct
impact on your product, alternatives are available
• Level 3: Moderate risk suppliers that have an
indirect impact on the product
• Level 4: Low risk suppliers that have no product
impact
10
2011

Audits
Example: Supplier audits based on
risk level – Action
2011
11
Level 1 Action
High risk supplier/service provider On-site audit
Level 3 Action
Moderate risk supplier Written audit
Level 4 Action
Low risk supplier Limited assessment / Audit not
applicable

Audits
Audit Frequency
Audit frequency is established based on risk and
performance (annual, biennial, triennial)
Frequency may change based on detection inputs from
assessment tools.
Increase audit frequency for adverse findings
Dependent on the status of third party certifications
Monitor supplier certifications = ensure
qualification programs are maintained
2011
12

Assessments
2011
13

Assessments
• Comparison Chart outlining supplier assessments
include:
• ICH Q10-Monitor and review the performance of the
contract acceptor or the quality of the material from
the provider
• EU Volume 4 Part II-Have system for evaluating
suppliers of critical materials, monitor
• GHTF-Depending on risk of suppliers may plan and
perform periodic re-evaluations
2011
14

Agreements
• Agreements ensure the quality of purchased
products/services.
• Quality Agreements = Agree to the QMS
expectations, define responsibility
• Change Agreements = Notification requirements
of changes in order to assess impact to your
process/product.
• Service Agreements
• Purchase Order
2011
15

Agreements
• Comparison Chart outlining supplier agreements
include:
• EU Volume 4 Part II-Formal agreement that defines/details
GMP responsibilities, quality measures of each party
• 21 CFR 820.50-Establish and maintain purchasing data with
specified requirements, notification of change agreements
• Health Canada-Written agreement outlining the specific
responsibilities of each party involved. Specify that the raw
material vendor must inform the drug fabricator of any
changes in the processing or specifications of the raw
material.
2011
16

Supplier Rating
• Supplier Scorecard results in improved supplier
performance, minimizes risk and sustains the
supply base.
• Develop scorecards with corporate
goals/objectives in mind.
• Quality, compliance, service, on-time delivery, cost
• “Where performance is measured, performance
improves”.
2011
17

Supplier Rating
• Supplier scorecards are used to measure and
monitor supplier performance.
• Identify attributes, agreements, factors and attribute
ratings
• Ensure the “highest factor” is what is most important
to your business needs
• Establish ratings: 90-100=Excellent,
75-89=Satisfactory, less than
75=Unsatisfactory
• Identify corrective action if applicable
2011
18

Supplier Rating
2011
19

Integrating valuable risk based and
• Ensure process is sustainable with growth of
supplier base and adheres to standards
necessary to support quality and compliance.
• Pre-defined decision tree for consistent
determinations and justifications
• Risk based decision tree helps maintain
consistency and provides justification as to why
the audit type, or lack thereof is chosen.
2011
20

Integrating valuable risk based and
Example: Decision Tree
•EXAMPLE
2011
21
Risk Assessment for Calibration Subcontractor Action
Certified to ISO 17025? Yes= Obtain cert for file
No= Written audit
Risk Assessment for Critical Component Action
Custom Built product? Yes=On-site audit
No= Go to next question
Certified to ISO? (applicable standard) Yes= Obtain cert for file
No= Written audit

Summary of Tools
• Objectives and goals
• Audits, assessments, agreements
• Risk Management: Ongoing supplier monitoring
• Audit selection based on supplier risk profile
• Supplier rating (Scorecard)
• Comparison tables
• Domestic and international reference tool
2011
22

Domestic and International
References
• GHTF/SG3/N17:2008- Control of Suppliers
• GHTF/SG3/N15R8- Risk Management Principles in a QMS
• GHTF/SG4/N84:2010 Guidelines for Regulatory Auditing of Quality Management Systems of
Medical Device Manufacturers Part 5: Audits of Manufacturer Control of Suppliers
• Health Canada - Good Manufacturing Practices (GMP) Guidelines GUI-001
• ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
• ICH Q10 Pharmaceutical Quality System
• EU Guidelines to GMP Part II Basic Requirements for Active Substances used as Starting
Materials
• ISO 13485 (Harmonized quality system standard adopted in Europe for medical devices)
• ISO 9000:2008 Principle 8: Mutually beneficial supplier relationships
• Japan Pharmaceutical Affairs Law (JPAL Ordinance 169)
• 21 CFR Part 210/211 21 CFR 820 Quality System Regulation(QSR)
• FDA’s “Guidance for Industry Quality Systems Approach to Pharmaceutical cGMP Regulations,
• Australian Government- Technical Guidance on the Interpretation of Manufacturing
Standards
• PIC/S Guide to Good Manufacturing Practice for Medicinal Products
2011
23

Questions?
Contact information:
Janeen Santarosa
Nelson Laboratories , Inc.
Phone: (801) 290-7671
jsantarosa@nelsonlabs.com
Thank you!
2011
24

Incorporate Domestic and International Regulations for Effective GMP Auditing

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