Vendor Development, Qualification, De-qualification and Requalification for Raw Materials & Packing Material

  • Objective: To lay down a procedure for the approval of vendors for raw & packing material and De-qualification and Re-qualification of existing approved vendors.
  • Scope:This Standard Operating Procedure is applicable for vendor qualification, De-qualification and Re- qualification of raw material & packing material to be followed.
  • Responsibility
    • In-charge of Purchase department or his authorized nominee is responsible for identification and selection of vendor.
    • In-charge of QA department or his authorized nominee is responsible for evaluation and audit of vendor.
    • In-charge of QC department or his authorized nominee is responsible for analysis of samples.
    • Head of QA department or his authorized nominee is responsible for the approval/rejection of vendor.
  • Accountability: Department Head & QA Head shall be accountable for implementation of this SOP.

 

  • Abbreviations and Definitions

SOP  : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.

QA : Quality Assurance

QC  : Quality Control

CoA :Certificate of Analysis

  • Procedure
    • The Head QA shall coordinate the vendor qualification process with Manager Purchase and other relevant departments.
    • Manager Purchase shall initiate the vendor qualification process for additional / alternative vendor(s) to the existing material(s).
    • Based on the reputation, quality standards and marketing trend analysis, Purchase Department initiate to make a possible new vendor list for each material.
    • Manager Purchase shall forward the vendor qualification questionnaire along with the current material specification obtained from QA and sent to the respective vendor(s).
    • The vendor qualification questionnaire (Annexure- I) consists of three parts.
      • Part A-Basic information (Site details, contact numbers, Production capacity, turn over, Organization performance, major customers etc.)
      • Part B-Technical information of the manufacturing site
      • Part C-Product specific information
  • For qualification questionnaire shall be sent to the vendor as stated below:
    • Complete (Part A, B & C) qualification questionnaire (Annexure –1) shall be sent to all vendors.
    • For the qualification of the new material from existing qualified vendor of the same site, Part C of qualification questionnaire along with specification shall be sent.
  • Vendor approval procedure for raw and packing material shall be as follows:
    • Vendor Approval for Raw Material
      • The Manager Purchase shall obtain the filled questionnaire and one pre-shipment sample along with certificate of analysis and minimum three CoAs from different batches.
      • The sample shall be analyzed as per current specifications by QC department. The results along with any other relevant comments shall be communicated to Head QA.
      • The Head QA shall assess the vendor based on the filled vendor qualification questionnaire against statutory and in house requirements along with the analytical results of the pre shipment sample.
      • Based on the compliance of statutory and in house requirements, the vendor shall be considered as qualified.
      • A vendor audit shall carried out jointly by Manager Purchase, Head QA and Manager Production whenever necessary as per Annexure II.
      • Wherever vendor audit shall be carried out, the final technical assessment of the vendor shall be done on the percentage score of the vendor from the Vendor Quality Audit Check list.
      • A vendor shall be considered as qualified if the score is 80% or above.
      • If the score is below 80%, corrective actions shall be suggested for system/facility updating.
      • Only after confirmation of the corrective actions the vendor shall be qualified.
      • All the vendors for the existing material shall be qualified by sending the qualification questionnaire and on the past performance.
    • Vendor Approval for Packing Material
      • The Manager Purchase shall obtain the filled questionnaire and at least one certificate of analysis from the vendors to check the tests carried out at the vendor end and shall communicate the same to Head QA.
      • The Head QA will assess the vendor based on the filled vendor qualification questionnaire and the certificate of analysis.
      • Based on the compliance of requirements indicated in the questionnaire, the vendor shall be approved.
      • Packing Materials shall be classified into the following categories namely:
      • Primary Packing Material
      • Secondary Packing Material
      • Tertiary Packing Material
      • A vendor Audit shall be carried out for primary printed and unprinted packing material as per vendor quality audit checklist (Annexure –II) by a vendor audit team comprising of representatives from Quality Assurance, Quality Control and Production Department as applicable.
      • Wherever possible / applicable Machine suitability test shall be carried out on pre shipment sample to check the suitability of the component. In absence of pre shipment sample, Machine suitability trial shall be carried out on first supply. Observations of the Machine suitability test shall be documented.
      • Vendor Audit shall be carried out as per vendor Audit checklist as per Annexure-II.
    • Vendor Approval certificate as per Annexure III, shall be issued to Manager Purchase, Manager Quality control and In-charge Warehouse.
    • Once the vendor qualifies in the technical assessment the Manager Purchase shall in parallel evaluate the commercial aspects.
    • The list of Approved Vendors as per Annexure IV shall be updated quarterly and further procurement of the material shall be carried out. The performance of the approved vendors shall review annually through assessment of history records of Vendors (Annexure-V).
    • Whenever there is a revision in the Raw material specifications, revised specifications shall be forwarded to the respective vendors through Purchase Department.
    • Purchase Department shall ensure the revised specification forwarded to the supplier before procuring the material from the effective date of specification.
  • Disqualification of Vendor
    • The Approved Vendor shall be Dis-qualified, if the vendor is not able to provide consistent quality product as per the specification consecutively for three times.
    • In the first rejection of a consignment of any material, the supplier shall be cautioned through the ‘caution/warning’ letter as per Annexure –VI, and shall be asked for a detailed investigation report, if the rejected parameter is not serious in nature. The further procurement of the material shall be kept under hold till the receipt of the investigation report.
    • Intimation shall be forwarded to the purchase department through ‘Vendor Activation/Deactivation Form’ (Annexure -VIII).
    • If the rejected parameter is serious in nature e.g. E.coli present, Assay failure, vendor site audit shall be conducted to identify the root cause for failure.
    • The further procurement of the material shall be kept under hold till the receipt of the investigation report highlighting corrective action plan from the vendor.
    • Vendor compliance shall be evaluated against vendor site audit report. If any targeted dates found in the compliance report, follow up audit / correspondence shall be conducted based upon the criticality.
    • After satisfactory completion of evaluation as per Annexure –VII (Vendor Assessment form), the vendor shall be re activated by sending a written communication Annexure -VIII (Vendor Activation/Deactivation form) to the purchase department.
    • Nimesulide B.P. 100 mg (drugsformulations.com)

Note:  Activation of the supplies shall only be given when all the corrective actions have been completed.

  • In the second instance of rejection of any material of the vendor from the same manufacturing site, a ‘caution/warning’ letter shall be issued as per Annexure–VI, Followed by re audit of the facility to identify the root cause for non-compliance.
  • The following disqualifications criteria shall be adopted in case if vendor is supplying more than one material from one site:
  • If the failure is originated from Quality system the vendor shall be disqualified.
  • If the failure is process related the products manufactured from that site of vendor shall be disqualified.
    • Above procedure shall be followed.
    • After satisfactory completion of evaluation as per Annexure-VII, the vendor shall be activated by sending a written communication Annexure VIII (Vendor Activation / Deactivation form) to the purchase department.
    • If any Material is rejected for the third consecutive time from the vendor at the same manufacturing site, then the vendor shall be ‘Black Listed’, with a notification to Manager Purchase, In-charge Warehouse, Manager Quality Control and a copy to the vendor through purchase department.
    • The Approved Vendor List shall be updated quarterly and as on when a vendor is qualified or de qualified as per Annexure – IV.
    • Approved vendor list shall be stamped as ‘Master Copy’
    • The document controller shall take photocopy of ‘Master Copy’ and stamped as ‘Controlled Copy’ as described in SOP.
  • Procedure for Provisional approval of vendor
    • In case of any urgent as per the market requirement the vendor will be provisionally approved as per the following (applicable only for excipients):
    • Purchase department in consultation with Head QA and Head QC to decide the vendor
    • Vendor’s agreement to supply material meeting the ‘Specification’
    • Review of vendor CoAs
    • Other commercial terms
    • In such case commercial lot from the provisionally approved vendor will be considered as vendor sample. Based on these considerations the vendor shall be provisionally approved vendor.
    • Vendor documentation for provisionally approved vendor shall be completed before second commercial consignment and then the vendor shall be consider as approved vendor.
  • Re-qualification of Vendors
    • Vendor shall be re-qualified once in two years based upon the history of earlier supplies.
    • If rejections, caution / warning letters found in the vendor history record, vendor shall be re-qualified followed by vendor site audit.
    • If the vendor is out-side the country, fresh questionnaire shall be issued and based upon the information, the vendor shall be qualified.
  • Forms and Records (Annexures)
    • Vendor Qualification questionnaire (Part –A, B (RM) & B (PM) and C) – Annexure I
    • Vendor Quality audit check list -Annexure II
    • Vendor Approval certificate -Annexure III
    • List of approved vendors -Annexure IV
    • History Cards of Vendors -Annexure V
    • Caution / Warning Letter -Annexure VI
    • Vendor assessment form -Annexure VII
    • Vendor activation / Deactivation form -Annexure VIII
    • Check List for Provisionally approved vendor  -Annexure IX
  • Distribution
    • Master copy –  Quality Assurance
    • Controlled copies- Quality Assurance, Production, Quality Control & Warehouse
  • History
DateRevision Number
Reason for Revision
New SOP

 

Ferrous Fumerate I.P. 300 mg (drugsformulations.com)

A 9 -

A 7 -

A 8 -

 

About Pharmaceutical Guidanace

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

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