Published on IVT Network (http://www.ivtnetwork.
com)
Incorporate Domestic and International Regulations for Effective GMP Auditing
Jul 22, 2013 10:43 am EDT
In this presentation from IVT's 2011 2nd West Coast Forum on Supplier Auditing, Janeen Santorosa discusses how to ensure
suppliers are operating with optimal quality systems. This session reviews and highlights guidelines and important takeaways
to implement into your current supplier management process highlighting:
Domestic and international regulations, guidances, and standards.
Best practices for harmonization:
Quality and compliance improvements for supplier management
Develop common standards which result in safer, more effective, higher quality products
Integrating valuable risk-based and sustainable practices:
Systems for managing and controlling suppliers (supplier assessments, quality agreements, supplier change
control, supplier audits)
Improve effectiveness of supplier activities through supplier rating
Join risk based and sustainable practices with supply chain, contract manufacturer/service provider
Supplier audit practice tools:
Domestic and international reference tools
Comparison table (domestic and international)
Periodic evaluation through supplier rating
Ongoing supplier monitoring
Identify audit selection based on supplier risk profile
Below a spreadsheet given as bonus material that breaks down each internationat regulation that pertains to supplier quality.
Compliance with these publications with guarantee FDA and international compliance!
Topic Scope: Supplier Qualification Comparison Chart
Australian Government - TGA Starting materials should only be purchased from approved suppliers named in the relevant specificatio
Guidance where possible, directly from the producer.
Manufacturers of intermediates and/or API’s should have a system for evaluating the suppliers of critica
EU Volume 4 Part II Materials should be purchased against an agreed specification from supplier or suppliers approved by t
units.
21 CFR 820.50, Purchasing Controls, requires in part: “Evaluate and select potential suppliers, contrac
FDA 21 CFR 820 consultants on the basis of their ability to meet specified requirements, including quality requirements. T
evaluation shall be documented.”
211.84, d (2) Each component shall be tested for conformity with all appropriate written specifications fo
strength, and quality. In lieu of such testing by the manufacturer, a report of analysis may be accepted f
supplier of a component, provided that at least one specific identity test is conducted on such componen
FDA 21 CFR 211 manufacturer, and provided that the manufacturer establishes the reliability of the supplier's analyses th
appropriate validation of the supplier's test results at appropriate intervals.
As part of the planning activities, the manufacturer should identify the risks associated with the product
to be obtained. When selecting potential suppliers the manufacturer should investigate their business an
GHTF/SG3/N17R9:2008
operational capability. The manufacturer should select potential suppliers according to predefined crite
results of capability investigations.
Testing other than identity testing: The testing is performed on a sample taken after receipt of the raw m
Health Canada GMP
the premises of the person who formulates the raw material into dosage form, unless the vendor is certi
Guidelines (GUI-001)
material vendor certification program, if employed, is documented in a standard operating procedure.
Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers of critical
Materials should be purchased against an agreed specification from supplier or suppliers approved by t
ICH Q7A 7.1
units. If the supplier of a critical material is not the manufacturer of that material, the name and address
manufacturer should be known by the intermediate and/or API manufacturer.
Purchasing process: The organisation shall evaluate and select suppliers based on their ability to suppl
ISO 13485
in accordance with organisation’s requirements.
Topic Scope: Supplier Assessments-Comparison Chart
Australian Period Review: As part of the qualification process a program for Periodic Review should be established. This program
Government- include a mechanism for removing the qualified status of a packaging or starting material supplier and should prevent t
TGA Guidance reduced sampling and reduced testing until identified critical issues are satisfactorily resolved.
EU Volume 4
Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials.
Part II
Purchasing Controls, requires in part: “Evaluate and select potential suppliers, contractors, and consultants on the bas
ability to meet specified requirements, including quality requirements. The evaluation shall be documented.” Define th
FDA 21 CFR 820
extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evalu
results.
Depending on the risk of the supplied product/service, the manufacturer may plan and perform periodic supplier re-eva
GHTF/SG3
regardless of whether problems have been identified. The purpose of this re-evaluation is to assess the supplier’s abili
/N17R9:2008
and output) over time to continue to meet specified product/service requirements as agreed.
ICH Q7A Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials.
Monitoring and review the performance of the contract acceptor or the quality of the material from the provider, and the
ICH Q10
identification and implementation of any essential improvements.
Topic Scope: Quality and Change Management Agreements
Australian
Government- Identification of all interactions with the material between leaving the manufacturer’s control and the final delivery
TGA Guidance finished medicinal product manufacturer can be useful. Steps to consider: Whether the supplier has a Technica
Agreement with the manufacturer and the content of the agreement (e.g. changes to the material, such as the me
manufacture or material supply).
Contract Manufacturers (including Laboratories) There should be a written and approved contract or formal agree
between the contract giver and the contract acceptor that defines in detail the GMP responsibilities, including the
EU Volume 4 Part II measures, of each party.
Changes in the process, equipment, test methods, specifications, or other contractual requirements should not be
unless the contract giver is informed and approves the changes.
Establish and maintain purchasing data/documents that describe or reference specified requirements (including n
FDA21 CFR 820.50
of change agreements).
The manufacturer and the supplier should have an agreed upon process for evaluating any changes to a validate
GHTF/SG3
and for determining when re-validation should be performed and documented. This needs to be captured in the a
/N17R9:2008
between the manufacturer and the supplier.
A raw material vendor certification program, if employed, is documented in a standard operating procedure. The p
Health Canada GMP
includes: Written agreement outlining the specific responsibilities of each party involved. The agreement specifies
Guidelines (GUI-001)
raw material vendor must inform the drug fabricator of any changes in the processing or specifications of the raw
General Controls: Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers
materials.
ICH Q7A Materials should be purchased against an agreed specification, from a supplier, or suppliers, approved by the qua
If the supplier of a critical material is not the manufacturer of that material, the name and address of that manufac
should be known by the intermediate and/or API manufacturer.
(ICH)Q10 Pharmaceutical quality systems guideline gives reference with manufacturer’s responsibility to assess s
ICH Q10
and competence of a supplier. Define in writing quality responsibilities.
Organizations purchasing information (including requirement for supplier records) should define appropriate requi
ISO 13485 7.4.2 and communicate them to the supplier to ensure the quality of the purchased product or service. Typically these
requirements are formalized in an agreement between the organization and the supplier.
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effective-gmp-auditing
