1. Purpose
This guideline aims to define the processes for certification of materials provided by suppliers including the requirements for maintaining materials in a “certified“ status for use.
2. Scope and Applicability
This guideline applies to materials procured and/or processed by suppliers for use at any stage in the manufacture of products for sale. The decision to certify and scope of the certification process should take into account the use of the material by the site and the risk to product quality. The principles of certification described in this guideline can also be applied to service providers.
3. Definitions
3.1 De-certification
Is the act of reverting back to full or partially increased testing of a specific material on its receipt from the supplier.
3.2 Lead Audit Team/Site (for Vendors)
The site/function that is accountable for conducting quality audits of suppliers.
3.3 Certification
Is the act of approving (accepting) quality control results provided by the supplier in relation to a specific material, thereby eliminating the need to undertake some or all laboratory tests on receipt of that material at the receiving site unless specifically required to meet regional/local GMP and/or import regulations
3.4 Material
A material is an Active Pharmaceutical Ingredient (API), intermediate, raw material, packaging component, excipients, formulated product, or packaged product.
3.5 Certified materials
A certified material is a material provided by a supplier, that is released by The site or released by a contractor directly into site’s distribution chain, without repeat laboratory testing by the site or an independent laboratory approved by the site, unless such testing is necessary to meet cGMP requirements, e.g. identity testing and/or local import regulations.
A certified material may undergo additional laboratory testing by the site or an independent laboratory approved by the site, if the supplier does not perform all tests required to release the material.
3.6 De-certified material
A de-certified material is a material that has had its ‘certified’ status revoked.
3.7 Vendor
A supplier of commercially available materials and/or services to the site.
3.8 Contractor
A person or entity agreeing to provide the sponsor (the site) with a service or material according to site’s specified requirements and intellectual property.
3.9 Supplier
An umbrella term that covers both Vendors/Contractors.
3.10 Lead Site (for Contractors)
The Lead Site is the site reflected in the Vendor and Contractor Database to be accountable for conducting specified material related QA activities. If no Quality Assurance Agreement Coordination site is assigned, the Lead Site would be responsible for GMP related interactions and issues, conducting audits, and development of the Quality Assurance Agreement.
3.11 Quality Assurance Agreement Coordination (QAAC) Team/Site (for Contractors)
The team/site assigned by Supply and Capability (S&C) to co-ordinate GMP related interactions and issues between an established contractor and the site including auditing and the establishment of the Quality Assurance Agreement, when the contractor supplies different materials assigned to more than one Lead Site.
3.12 Receiving Site
A sponsor site/function receiving materials or services from a supplier.
3.13 Receiving Site Supplier Certification Team
A Site Supplier Certification Team is a team composed typically of the following representatives: Quality Assurance, Quality Control, Purchasing, and Technical.
This team should be lead by a representative of Quality.
3.14 Certification Report
A compilation of all information gathered by the Receiving Site Supplier Certification Team supporting the award/re-assignment of certification status.
3.15 Supplier Status
The status of the supplier is decided by the LAS (vendors) or QAAC (contractors) based on a compilation of quality related information on all materials received from the supplier site and entered in the VA&C Database. The status of a specified supplier in the database may be either:
a. Preferred or acceptable supplier site – no or minor issues only
b. Major issues and concerns with the supplier site that are being addressed.
c. Major issues and concerns with the supplier site that are not being addressed/recommendation to find alternative supply or suspend supply until significant improvements are made.
3.17 Material Status
This is the certification status of a material that is awarded by each Receiving Site and recorded on the VA&C Database. For information, the status of materials/products from a specified supplier in the database may be either:
(i) Certified – the material from a specified supplier site fully meets the site’s requirements and material may be released for use without the need to repeat any tests conducted by the supplier unless specifically required to meet regional/local GMP and/or import regulations, e.g. Identity Testing.
(ii) Pending Certification – the supply is recognized (approved) by the site and the material has been targeted for certification within the current year.
(iii) Not Certified– The supply is recognized (approved) but has not been certified.
(iv) De-certified – the supplier site has failed to satisfactorily maintain the criteria required for Certification (e.g. cGMP compliance etc).
(v) Discontinued – the supplier site no longer provides the material to the site.
4. Responsibilities
Certification is ultimately the responsibility of the Quality Assurance Department of each site receiving the material directly from the supplier site (Receiving Site).
4.1 Lead Audit Site/Lead Site/QAAC Site
The Lead Audit Site for Vendors and the Lead Site for Contractors should make a recommendation to the Receiving Sites on the certification status of materials delivered to receiving site by a Supplier based on the outcome of the audit(s) it has conducted. The appropriate QAAC site co-ordinates GMP related interactions and issues between an established Supplier and the receiving site and is responsible for the preparation and negotiation of the Quality Assurance Agreement (which maybe a stand alone agreement, may be combined with a business contract, or may be called a Certification Agreement).
4.2 Receiving Site Supplier Certification Team
The Receiving Site Supplier Certification Team for each Receiving Site is responsible for deciding/reviewing the certification status of all materials received by the site according to established quality criteria, taking into account the relevant Lead Audit Site/Lead Site/QAAC Site’s recommendations. If multiple sites receive the same material, the receiving sites should share information as to the acceptability of the material/supplier.
5. Guideline
The general process for awarding a certified status to a material from a specified supplier site is based on the following items.
a. Quality Assurance Agreement (or for vendors only, a Supply Agreement containing a section detailing quality related requirements)
b. Periodic Audit
c. Quality Review/Risk Assessment by each Receiving Site considering the following items:
– A review of analytical methods, specifications, etc., used to determine any potential impact upon Regulatory registrations.
– Approved Technology Transfer to the Supplier by receiving site.
– Identification of the supply chain for the material (i.e. how the material will be delivered to the Receiving Sites).
– A review of material quality and supply performance based on data/information generated by the Supplier and receiving site. This can be from other materials received by the receiving site from the supplying site.
NOTE: To maintain a status of ‘certified’, materials should be subject to a documented periodic quality review.
5.1 Material Certification Process
NOTE: This guideline applies to hazardous materials, as well. However, all sections may not apply. It is up to the receiving site to use applicable sections of this guideline to certify hazardous and other materials as applicable.
The existence of an approved Quality Assurance Agreement (or for vendors only, a Supply Agreement containing a section detailing quality related requirements) with the Supplier Site and a recent audit of the Supplier Site are essential prerequisites for the award of a ‘certified status’ to a material supplied to the receiving site.
5.1.1 Material Quality Review and Risk Assessment
The following checks/reviews/assessments should be performed and documented as a basis for the award of ‘certified status’ to material from a specified supplier site.
– The Supplier’s delivery and quality performance
– Audit reports, corrective action plans, and closure reports.
– Test methodology used by the supplier, and its equivalency with any registered methods (including review of any reports on technology transfer of test methods between the receiving site and the supplier site).
– In cases where the test methods are different, their equivalency should be demonstrated based on a review of historical data or parallel testing of no less than 3 batches.
– The format of Certificate of Analysis (CofA)/Certificate of Compliance (CofC) for the material supplied. Details as to the content of the CofA/CofC will be specified in the appropriate Agreement.
– A risk assessment based on the nature of the material and its criticality to product and/or process in which it is used at each Receiving Site.
5.1.2 Application of ‘Certified’ Status at each receiving Site
The Receiving Site Supplier Certification team should document the outcome of the certification assessment in a Certification Report and when appropriate, will upgrade the certification status on the VA&C Database. The certification status of all materials/products will be reviewed periodically.
5.2 Record Retention and Archiving
Certification Reports and accompanying documentation should be filed within each Receiving Site Quality Assurance archive.
5.3 Review of Certification Status
A periodic review of the certification status of each material from a supplier site will be conducted and documented by each Receiving Site that has received deliveries during the time period based upon the following criteria:
* Regulatory Compliance
* Quality Agreement Compliance
* Service Performance
* Non-Conformities/Complaints
* Certificate of Analysis/Conformity
* Last Audit/Questionnaire
* Supplier Analytical Method Review
* Received Batches Analytical and Clearance Status Review
* Recommended Testing Protocol
* Change Control
* Trend Analysis (when applicable)
* Compliance confirmation of full testing (performed at appropriate intervals)
* Progress with audit observation closure
* Compliance Status of Supplier (RAG)
* Periodic testing of the certified material. (This is only performed when required by the local GMPs of the receiving site).
If appropriate, the certification status of the material shall be downgraded to ‘decertified’ or may stay ‘certified’. This revised status shall be periodically reviewed.
An updated version of the “Certification Report’ should be issued to include the latest status. Receiving Sites should send a copy of their updated “Certification Report’ to other sites (if any) receiving the same material from the same supplier site together with the Lead Audit Site, so they may be aware of any new issues with the supplier.
5.4 Criteria for Maintenance of Certification Status
If no critical defects were observed during the latest audit, no serious problems or observations were noted with the monitoring program, and no serious observations were noted during the periodic quality review, the Receiving site may make the recommendation that the supplier shall maintain their status of “Certified Supplier” for use at receiving site Operations.
5.5 Criteria for De-certification
During the routine review period of certification status, the Receiving Site may determine that the material no longer meets the criteria for certification. Note: This may occur outside of the normal frequency of assessing the Supplier. The Receiving Site Supplier Certification team, using the following criteria, should determine the severity and scope of non-compliance by the supplier for assessing if de-certification is warranted. If areas were identified during the on-site audit, monitoring program, or in the historical quality review that poses a vulnerability for receiving site Operations, the Receiving Site Supplier Certification team should make the recommendation that the supplier shall be de-certified.
* Poor or failing historical quality review
* Critical citations or observations from the presiding regulatory agency that severely limits the supplier’s ability to fulfill its contractual obligation with receiving site’s operational site
* De-emphasis on the role of quality in the organization that can jeopardize or compromise the quality, purity, safety, and efficacy of the product
* Direct cause of a product recall due to the use of a material that can be traceable to the supplier.
* Unacceptable resolution or outstanding critical observations that have not been successfully resolved to receiving site satisfaction that were made during the last on site audit.
* Inability of the supplier to provide the materials or services as specified in the contractual agreement or Quality Agreement due to circumstances within or beyond their control.
* Intentional fraud or subterfuge on the part of the supplier that can impact receiving site products on the marketplace.
5.6 Criteria for Re-Certification after Supplier Deemed De-Certified
When a supplier is deemed de-certified, a corrective action plan should be developed with the supplier. Once the requirements of the corrective action plan have been met (i.e. acceptable responses received from a “for cause” audit or other), the supplier may be considered for certification. This may include parallel testing on receipt or may require supplier to go through the entire certification process.
5.7 Documentation of Certification Review
The team documents the outcome of the certification review as an addition to the existing Certification Report, including supporting documentation listing why the supply was assigned the rating (i.e. decertified/certified). For a supply that has been given a de-certified rating, the documentation must include the reason(s) why the supply was de-certified and the corrective action required. Following the certification review, the certification status of the materials held on the receiving site VA and Contractor database shall be updated by the appropriate Receiving Sites and the records will be archived.