Vendor Development and Approval (API and excipients)
- OBJECTIVE :
To lay down a procedure for vendor audit for raw material, developing and approving the vendor who can consistently supply the raw materials with right quality and quantity at right time.
- SCOPE :
This Standard Operating Procedure is applicable to approve the vendor as per GMP requirements, for supplying the materials as per approved specification and requirements of Pharma company.
- RESPONSIBILITY :
Purchase Head, QC Head and QA Head shall be responsible to follow the procedure mentioned in this SOP.
QA Head shall be accountable for compliance of the procedure mentioned in this SOP.
- ATTACHMENTS :
Vendor Sample for Analysis Attachment – I
Vendor Questionnaire for Raw Material Attachment – II
Vendor Audit Checklist for Raw Material Attachment – III
Vendor Audit Close Out Record Attachment – IV
Vendor Evaluation Report Attachment – V
Approved Vendor List Attachment – VI
Audit Summary Report Attachment – VII
Intimation for Vendor Approval /Rejection Attachment – VIII
Quality Defect Information Memo Attachment – IX
Audit checklist for supplier/ Distributor Attachment – X
Quality Agreement Attachment – XI
Vendor Audit: A vendor audit is a vehicle which is used to inspect and evaluate manufacturing, supply, quality management system, practices, procedures and documentation procedures followed by the vendor.
QA shall prepare the vendor audit schedule for raw material.
QA shall inform to the all concerned and Purchase Department Head in advance regarding agenda, scope and audit details.
In general audit shall cover six systems but not limited to:
- Material Management System
- Facility and Equipment System
- Production and Process Control
- Packing and Labelling control
- Laboratory Control
- Quality Management System
During audit (in case of schedule audit) status of last audit CAPA (if applicable) shall be verified.
A need for a new vendor may arise due to:
A new product launch
An alternate vendor
Existing vendor with an additional product.
In case of raw material to be used from an existing vendor for new product and new vendor.
Purchase Department shall identify the source of material as per the GMP requirements, share the approved specification along with particle size distribution requirements, and arrange the samples accordingly from three different consecutive batches/lots along with the certificate of analysis for evaluation.
Purchase Department shall also arrange the working standard, impurities, vendor specification, testing procedures, MSDS and technical enclosures.
Purchase Department shall submit the sample along with the documents (all required) received from the vendor. Same shall be sent to QA as per the Attachment-I.
QA shall review the vendor documents. If found satisfactory, vendor samples shall be handed over to QC for analysis as per approved specification. After analysis QC shall prepare a report.
Based on the results received from QC, QA shall inform to Purchase Department accordingly.
If the vendor material complies with the specification, vendor questionnaire shall be shared with the vendor through Purchase Department. Details of vendor questionnaire are available in Attachment-II.
Following documents shall be requested by the Purchase Department along with duly filled questionnaire.
Declaration for BSE (Bovine Spongiform Encephalopathy), TSE (Transmitting Animal Spongiform Encephalopathy), stability study (Accelerated and long terms) with declaration, change in manufacturing process which will propose after vendor approval system, residual solvent/OVI (Organic Volatile Impurity) declaration, GMO (Genetically Modified Organism) Free certification, MSDS, Melanin Declaration.
- DMF required, if applicable
- Manufacturing license
- Accreditations (GMP Certificate or other regulatory certification)
- Brief manufacturing process along with flowchart
- Vendor shall provide the above declarations on their formats or letter head hence no need to fill the information in the questionnaire by the vendor.
QA shall review the pre-audit questionnaire alongwith the documents and recommend to conduct a vendor audit for evaluation of facility for the GMP requirements. Audit shall be performed as per the guidance given in below table.
|Material||Questionnaire||Pre shipment sample report||Physical audits|
|Active Raw material||√||√||√|
Purchase Department shall organize the audit date mutually agreeable at both ends. Re-audit of the site for additional item shall be optional. Audit shall be performed by a team of auditors (comprising of representatives from GMP relevant departments). QA shall formulate a team of auditors.
The auditors shall audit the facility by using detailed checklist as per Attachment-III.
After completion of audit, deficiencies/observations shall be mentioned in Vendor audit close out record, Attachment-IV and shared with the vendor through Purchase Department.
Deficiencies shall be categorized as per below:
- Critical Deficiencies: These observations have direct impact on product quality, safety, efficacy, purity or violation of regulatory requirement. These deficiencies must be closed during the audit or if not closed immediately, the audit shall be stopped, material will not be procured.
- Major Deficiencies: These observations have direct impact on system, procedure or control, to product quality, efficacy, safety, purity of product or observations are in repetitive in nature. These observations shall be closed within 30 days.
- Minor Deficiencies: The observations which do not affect the product quality, safety, efficiency, purity, but have impact on quality system. It must be closed within 45 days.
- Prior audit observations shall be evaluated during re-audit.
After the audit, QA shall forward the vendor audit report along with deficiency /observations to the Purchase Department for sending to the vendor to submit the compliance within 60 days.
If audit compliance report alongwith required documents is found satisfactory, QA shall send the vendor evaluation report to the Purchase Department within ten days after the date of receipt of satisfactory compliance report. Vendor evaluation report shall be prepared as per Attachment-V. Parallel, QA person shall add the vendor name in the approved vendor list, Attachment-VI within 7 days as an addendum.
Approved vendor list shall be updated once in a year.
After receipt of Vendor Evaluation Report (Attachment-V), Purchase Department shall procure the API as per the required specification.
Manufacturer & supplier (API & Excipient) shall be controlled appropriately based on the results of a formalized quality risk assessment procedure maintained by the procedure.
For excipients from a particular vendor if 10 consecutive supplies comply with the specification and fulfil Pharma company requirements, then the vendor is considered as approved vendor.
Technology transfer products:
In case of new raw material procured for new products launch, vendor documents shall be evaluated by QA and three consecutive batches samples shall be analyzed by R&D and results shared to QA. After receiving QA recommendation, material shall be procured.
Procedure for development of alternative vendor for Raw material
Purchase department shall identify the alternative vendor of Raw material.
Purchase department will arrange the sample for 3 different commercial batches along with COA, each about 100 gm / 300 gm for analysis.
Purchase Department forwards the sample and duly filled alternative vendor documents to QA Head / Quality Assurance Department. QA forwards the sample to QC for analysis.
Quality Control Department analyses the sample and after analysis the report will be forwarded to QA along with COA and comments.
Head Quality Assurance reviews the COA for compliance against the specification.
On the basis of COA, Head Quality Assurance may approve or reject of vendor.
QA informs the Production, Warehouse, Quality Control and Purchase Departments about approval/rejection of alternative vendor.
Change in vendor name and address:
In case there is a change in vendor name and address Purchase Department shall raise the change control along with technical documents.
The team of auditors shall perform the site audit for new manufacturing address for raw material.
Frequency of audit and re-audits
Facilities of the vendors shall be liable to re-audit.
|Material||Questionnaire||Desktop Audit||Physical audits|
|Active Raw material||3 years||3 years||5 years|
|Excipients||3 years||3 years||NA|
Other than these cases vendors shall be liable to re-audit in following cases
If there is any recall of the finished products due to the raw material sourced from the particular supplier/vendor.
Change in manufacturing facility within same premises or relocation of the facility.
Change in any manufacturing process which is directly impacting Pharma company QMS system.
After receiving repeated serious complaints from the customer as well as regulatory authority.
After revival to major accident in the facility i.e. fire.
Quality risk assessment procedure for re-audit
QA shall maintain record for every vendor, its quality commitment and supply track record.
Each non-conformity supply from the vendor (irrespective of product, brand, or generic form of the supply) shall be recorded.
QC shall intimate each rejection to the Purchase, QA and Production Department. Based on intimation Purchase shall intimate vendor about the rejection and reason of rejection. QA shall maintain the record for rejection in “vendor-wise non conformity record”.
In case of two consecutive non-conformity supplies; vendor must provide formal investigation report to Pharma company.
In case of three consecutive non-conformity supplies; vendor shall be barred from further supply till he provide CAPA and subsequent approval from QA.
In case of vendor’s failure in provide satisfactory CAPA; QA shall organize on-site audit of the vendor.
In case of no rejection in supplies, re-audit schedule must be followed as per 6.8.2.
Desktop audit shall be applicable for above mentioned table (refer point 6.8.2).
Desktop audit shall be done with the frequency mentioned in above said table (refer point 6.8.2).
Vendor questionnaire shall be sent to the concerned manufacturer through Purchase Department along with the following requirements.
- Declaration for stability study (Accelerated and long terms)
- Declaration for change in manufacturing process which will propose after vendor approval system.
- Declaration for any replacement of solvents or increasing the usage of recovered solvent.
- Declaration GMO (Genetically Modified Organism) Free certification
- Manufacturing license
- Updated accreditations (GMP Certificate or other regulatory certification)
- Brief manufacturing process along with flowchart, if any change.
- Vendor shall also provide the documents like PQR summary and conclusion report, brief summary and mechanism of manufacturing process.
- Along with all the declaration documents, vendor shall also provide the documents related to changes in facility, process, packing material changes and change in raw material sources.
Vendor shall provide the above declarations on their formats or letter head hence no need to fill the information in the questionnaire by the vendor.
QA shall evaluate all the documents and recommend Purchase Department to continuation of procurement material as usual.
Supplier/ Distributor audit
Physical audit for supplier/ distributor, who are different from manufacturer, shall be performed as per the checklist as per Attachment-X.
After evaluation of audit compliance QA shall recommend to Purchase Department for preparation of agreement between vendor and Pharma company.
During preparation of agreement legal and quality precautions shall be mentioned and implementation for the same shall be mandatory.
Any major issues of concern identified during facility audit shall be resolved prior to final approval of the facility or before procurement.
QA shall review all the documents in the procedure, if satisfactory as per the procedure, update the approved vendor list and proceed for procurement as well as using of the material in the premises.
Intimation of addition / deletion / approval / rejection of a Vendor.
QA department shall intimate for vendor approval or rejection with the intimation for vendor approval/rejection as per Attachment-VIII.
Company shall accept the consignment from the new vendor on receipt of copy of vendor evaluation report duly, Attachment-V, marked as Approved from QA.
Approved vendor list shall be revised annually, if any vendor is added in the middle of the year, it shall be added through addendum.
Based on the vendor approval by sister concern company, API or excipient shall be procured from the same vendor.
If three consignments in a year do not comply with the specification, vendor shall stand for re-certification and material shall not be purchased until the re-certification of vendor takes place and Quality defect information memo shall be shared to vendor as per Quality defect information memo, Attachment-IX.
Quality agreement will be signed with the vendor as per Attachment-XI.
If approved vendor is going to supply the new raw material from its approved site, in such cases only addendum to quality agreement will be provided.
PIC/S (Guide for Good Manufacturing Practice for Medical Product Part-II)
cGMP: Current Good manufacturing Practice
GMP: Good Manufacturing Practices
COA: Certificate of analysis
PQR: Product Quality Review
API: Active Pharmaceutical Ingredient
BSE: Bovine Spongiform Encephalopathy
TSE: Transmitting Animal Spongiform Encephalopathy
R&D: Research and Development
MSDS: Material safety data sheet
GMO: Genetically modified organism
CAPA: Corrective and Preventive Actions
OVI: Organic Volatile Impurity
DISTRIBUTUON LIST :
Quality Assurance Department
Quality Control Department
Research and Development Department:
HISTORY OF REVISION:
|Reason for Revision
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube