Thursday, 11 July 2019

Vendor Qualification

Vendor Qualification
Purpose
To describe the procedure for vendor qualification and certification for raw and packaging materials for cGMP compliance at vendor's (Manufacturer/Supplier) manufacturing site.
Procedure
Vendor Audit: A vendor audit is a vehicle which is used to inspect and evaluate a vendor's (manufacturer/supplier) quality management system, as well as its practices, products and documentation.
Vendor audit procedure:
Vendor audit shall be carried out in following cases (For Raw Material and Packing Material) if required.
Qualification audit (New Vendor and Alternate Vendor Development).
Vendor Audit shall cover six systems but not limited to:
          Material Management
          System Facility and Equipment System
          Production and Process Control  
          Packaging and Labeling Control
          Laboratory Control
          Quality Management System
During audit, status of last audit CAPA (Corrective Action & Preventive Action) shall be verified/ reviewed.
Audit observations to be discussed during audit close out meeting with auditees.
Audit observations shall be categorized as:
          Critical
          Major
          Minor
Critical Observations: Observations which directly affects the quality, Safety, Purity of the product & can cause potential health hazards to customer.
Major Observations: Observations which indirectly affects the quality, Safety, Purity of product and which are not complying cGMP practices. Corrective action to be taken immediately.
Minor Observation: Observations which does not have impact on quality of product, which can be noted and corrected at scheduled program.
Signed & scanned copy of audit report shall be issued to vendor through e-mail along with copy to concerned departments within 15 working days from day of audit.
Vendor shall submit CAPA for audit observations within 30 working days from receipt of audit report.
Follow ups for CAPA shall be taken from vendor by QA personnel. In case CAPA is not received then it shall be the responsibility of purchase department to provide the CAPA from the vendor.
Based on review of submitted CAPA vendor can be approved or rejected.
In case of approval of additional Raw material and Packaging materials from already approved and audited vendor, re-audit of site is optional. Audit can be done in below cases:
If raw material/ packaging material is manufactured in new manufacturing block with multiple product facility.
If material is manufactured in new manufacturing block and is dedicated for said product, then re-audit is not required.
Vendor Audit Schedule:
QAD personnel shall prepare audit schedule for Raw Materials.
QAD personnel shall prepare audit schedule for Packaging Materials
Initiate vendor audit in co-ordination with purchase department as per vendor audit schedule.
Head QAD/Designee shall coordinate with Head-Purchase/Designee for audit date.
Inform vendor and Head Purchase well in advance regarding agenda, scope and proposed duration of audit.
Inform all concerned well in advance, in case audit is preponed or postponed due to some or other reason.
For Raw Materials following updated documents (but not limited to) shall be obtained from vendor:

For Raw Material:
          Vendor Questionnaire
          Material Specification
          TSE/BSE Declaration
          Residual Solvent Declaration
          Material Safety Data Sheet
          Updated Stability Data
          Latest Regulatory GMP certificates
          Declaration letter in case any change in manufacturing processing
Vendor will be considered as approved in case of:
          FDR/ARD recommendation for Bio Batches / Trials / Validation to be conducted at site and/ or at FRD.
          Satisfactory vendor audit & compliance.
          Satisfactory review of vendor qualification documents as per procedure.
Note: Batches manufactured using API supplied by un approved vendor shall not be commercialized prior. The status of vendor shall be made “Approved” in Designated Software system prior to commercialize of batch.
Vendor Qualification will be done for:
          New Vendor Development.
          Alternate vendor development.
          Vendor to be raised for New Item code and / or new material which are to be used for first time.
          Development of another vendor as an alternate source for existing item code.
Procedure for new vendor development (Raw Material):
For initiating the qualification of any new Raw material supplier/ manufacturer, purchase Department shall forward ABC Limited specification of the specific Raw material and “Vendor Questionnaire” to vendor.
Purchase department shall receive samples of three batches quantity sufficient, for 2 QC analysis along with Certificate of Analysis complying ABC Limited specification, WRS with COA (if required) and filled “Vendor Questionnaire”.
Vendor should revert with filled “Vendor Questionnaire” within 15 working days. 
Samples along with the Certificate of Analysis and “Filled Vendor Questionnaire” shall be forwarded to the Head Quality Assurance.
If “Vendor Questionnaire” and Certificate of Analysis are found satisfactory with the ABC Limited Specifications, QAD shall send the sample along with COA(Certificate of Analysis) to QCD for analysis.
QAD shall record Vendor sample details.
QCD shall analyze the sample as per the ABC Limited specification.
For API based on the analytical results and Vendor Questionnaire review, if both found satisfactory intimate to purchase department and vendor audit may or may not be planned. Vendor can be qualified based on the analytical results and document provided.
In case of failure, QAD shall communicate the findings to purchase department to inform the manufacturer.
In case of excipients, vendor may be approved /rejected on the basis of the provided documentation.
QAD shall intimate to purchase department to arrange the required documents & sufficient quantity of API, required to take three trail batches.
If the raw material (API & excipients) manufacturers has manufacturing unit out of India then RM supplier shall provide all the required documents and based on the provided documents, vendor can be approved/ rejected.
Audit shall not be done for those Manufacturer/ Supplier approved by any regulatory agencies and based on the documents provided, vendor can be approved.
The representatives from Quality Assurance shall carry out vendor audit.
Vendor Audit shall be carried out to review the vendor for Quality System, Manufacturing process capabilities, delivery and commitment to prevent Quality problems based on:
          Quality management system at company premises.
          Technical capabilities of the firm.
          Financial soundness and performance of the company.
Vendor shall be evaluated as per respective “Vendor Audit Checklist”
Vendor should revert with compliance report within 30 working days.
On receipt of the compliance report from the vendor, submit the “Vendor Evaluation Form” along with the copy of audit findings and Compliance report to Head QA.  Head QA reviews the details. If found satisfactory informs the Purchase Department to proceed for signing the “Audit Closer Note” with the vendor.
Purchase department shall ensure that the “Audit Closer Note” is signed between the vendor and ABC  Limited.
In case a new vendor is approved, include the vendor “Details of New Approved Vendor”. After three-month review vendor shall be added in approved vendor list.
QA shall maintain the separate approved vendor list for Active Raw Materials.
Vendor evaluation and rating summary shall be performed on yearly basis and same shall be recorded.
Based on trend data, percentage rejects shall be calculated for each manufacturer and quality rating/score shall be done as per given blow procedure:
          For example, if a vendor has supplied 25 batches to the plant and 2 out of 25 batches were rejected by QC/complaint received, the percentage rejects shall be 2/25 X100= 8%.
The quality score shall be calculated by subtracting percentage reject from 100% i.e. 100-8 =92%.
Note: In case percentage is coming out in decimals, lower side of national numbers shall be considered.
If rating of the vendor goes below the quality acceptance level then the vendor shall be informed for the same.
On the basis of rating & trend data, Head-QAD shall give decision to reject for further supply of vendor. Re-approval of vendor shall be done as per the Vendor Qualification procedure.
Procedure for new vendor development (Packing Material):
Packaging materials are categorized as primary, secondary and tertiary material.
Primary Packing Material: The material that first envelops the product and holds it.  This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents.  Example : CAN’s, Valves, Actuators etc.
Secondary Packaging Material: The materials that holds the primary packaging.  Example: Cartons,  Plastic tray etc.
Tertiary Packaging Material: The material is used for bulk handling, warehouse storage and transport. Example: Shippers, BOPP tapes etc.
Vendor approval of packaging materials (Primary, Secondary  and Tertiary):
For initiating the qualification of any new Packing material supplier/ manufacturer, purchase Department forwards the “Vendor Questionnaire” specific to the Packing materials.
Vendor should revert with filled “Vendor Questionnaire” within 15 working days. 
Purchase department shall receive the filled “Vendor Questionnaire” and required documents forwards to Head-QAD.
Head Quality Assurance shall review the Vendor Questionnaire. If Questionnaire found satisfactory Vendor Audit shall be planned.
In case of primary packing material and printed material, vendor audit shall be done. However in case of unprinted packing material and tertiary packing material vendor can be approved on the basis of provided documentation.
For Packing Materials following updated documents (but not limited to) shall  be obtained from vendor:
For Packing Material:
          Vendor Questionnaire
          Food Grade certificate
          Material Safety Data Sheet (as applicable)
          Solvent Declaration
          Latest Regulatory GMP certificates
Declaration letter in case any change in manufacturing
Vendor Audit shall be carried out to review the vendor for Quality System, Manufacturing process capabilities, delivery and commitment to prevent Quality problems based on:
          Quality management system at company premises.
          Technical capabilities of the firm.
Financial soundness and performance of the company.
If the vendor has manufacturing unit out of India then PM supplier shall provide all the required documents and based on the provided documents, vendor can be approved/ rejected. Vendor audit may or may not be done for those vendor having manufacturing unit out of India
Manufacturer/ Supplier approved by any regulatory agencies, audit shall not be done for and based on the documents provided vendor can be approved.
Vendor shall be evaluated as per respective “Vendor Audit Checklist”
After the vendor audit, any non-compliance observed during the inspection are compiled and forward to the vendor within 15 working days after audit closer.
Vendor Audit Report Shall be prepared
Vendor should revert with compliance report within 30 working days.
On receipt of the compliance report from the vendor, submit the “Vendor Evaluation Form” along with the copy of audit findings and Compliance report to Head QA.  Head QA reviews the details. If found satisfactory informs the Purchase Department to proceed for signing the “Audit Closer Note” with the vendor.
Purchase department shall ensure that the “Audit Closer Note” is signed between the vendor and ABC Limited.
In case a new vendor is approved, include the vendor “Details of New Approved Vendor”. After three-month review vendor shall be added in approved vendor list.
QA Shall maintain the approved vendor list for Packing Materials.
Vendor evaluation and rating summary shall be performed on yearly basis and same shall be recorded
Based on trend data, percentage rejects shall be calculated for each manufacturer and quality rating/score shall be done as per given blow procedure:
 For example, if a vendor has supplied 25 batches to the plant and 2 out of 25 batches were rejected/complaint received, the percentage rejects shall be 2/25 X100= 8%.
The quality score shall be calculated by subtracting percentage reject from 100% i.e. 100 -8 =92%.
Note: In case percentage is coming out in decimals, lower side of national numbers shall be considered.
If rating of the vendor goes below the quality acceptance level then the vendor shall be informed for the same.
On the basis of rating & trend data, Head-QAD shall give decision to reject for further supply of vendor. Re-approval of vendor shall be done as per the Vendor Qualification procedure.
Change in Vendor Name & Address:
In case there is change in vendor name (e.g.  From X Ltd to Y Ltd), purchase department shall intimate to QAD.
In case there is change in vendor manufacturing site address, purchase department intimate to QAD and provide the technical documents / enclosures.
Documents  like (but not limited to) change  in manufacturing site declaration, vendor declaration  letter for  new  manufacturing  site  address,  declaration  for  no  change  in manufacturing process, vendor questionnaire,  material specification,  certificate of analysis, residual solvent declaration, TSE-BSE declaration, material safety data sheet.
QAD shall initiate the change control for change in respective documents.
QAD shall perform the site audit of new manufacturing unit.
Procedure for Inclusion of material with different Pharmacopoeial grade:
In such cases, vendor shall be treated as new vendor and new item code shall be assigned.
Purchase shall raise vendor qualification documents as per defined procedure.
Procedure for generation of new item code for existing approved material:
In case, there is need for generation of new item code for existing approved excipient, same  can  be  done  through  Change  control  procedure  and  thereafter  approval  of change control same shall be included in Designated Software.
New Item code shall be generated in below conditions, but not limited to:
          Required for specific market or customer
          Required for specific product based on criticality

Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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