Vendor Qualification SOP

SOP for vendor qualification in pharmaceutical industry | Vendor qualification checklist | Vendor Qualification Process |

Vendor qualification sop covers below points:
- Vendor qualification purpose
- Selection of Vendors
  - Selection of New Vendors for Existing Materials
  - Selection of Vendors for New Materials
  - Selection of Existing Vendor Approval
- Criteria for Vendors Selection and qualification
  - Criteria for Vendors Selection of Active Pharmaceutical Ingredients – API
  - Criteria for Vendors Selection of Excipients
  - Criteria for Vendors Selection of Packaging Materials
- Disqualification of Vendor
- Frequency of Updation of Approved Vendor list
- Vendor Audit Checklist Active Pharmaceutical Ingredients – API
- Vendor Audit Checklist for Excipients
- Vendor Audit Checklist for Packaging Material

1.0 OBJECTIVE :

To lay down a procedure for identification, selection, qualification, approval or rejection of potential manufacturer and periodic evaluation of approved manufacturers of raw (active and excipients) and packaging materials.

2.0 SCOPE :

This procedure is applicable to approve vendors (the manufacturers) of raw (API and Excipients) and packaging material used for manufacturing own products.

3.0 RESPONSIBILITY :

Purchase Head is responsible to identify the potential manufacturers with help of Quality Assurance, Quality Control and Formulation and Development departments.
Quality Control Head is responsible to test the bulk material or sample received from the vendor.
Production Head is responsible for initiating the need for any new material.

4.0 ACCOUNTABILITY:

Head Of Department Purchase, Production, Quality Control and Quality Assurance

5.0 PROCEDURE :

Vendor Qualification procedure is very important as the starting materials used for the manufacturing of the Finished products have a major impact on the quality of the Finished product. As far as possible material will be purchased from indigenous manufacturers directly.

Quality Assurance department issue soft copy of annexure (1 to 6) to purchase department.

Purchase Department or Vendor is not authorized to amend. Both soft (Pdf) or hard copy of filled questionnaire is acceptable.

5.1 Selection of Vendors:

New Vendors for Existing Materials (RAW AND PACKAGING MATERIAL)
- Purchase Head is responsible for initiating the need for new vendors for technical or commercial reason.
- Carry out pre assessment of new vendor on capability with the help of Head Quality Assurance and Quality Control.
- Purchase department search the vendor as per requirement by considering the proximity of vendor and list new vendor with address, email and phone number.
- Purchase Head sends the detailed specification of material IP/BP/USP/In-House as per requirement to the potential vendor through mail and ask them to send the sample of three batches for raw material along with COA. Ask them to arrange “Open part of the Drug Master File” (DMF), TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy) free statement if derived from animal source whatever available/applicable and valid accreditation, for example, MHRA, EU, US-FDA,ISO,GMP etc as per their availability, representative sample of packaging material along with COA, TSE and BSE free statement if derived from animal source.
- After receiving the pre purchase sample along with COA the Purchase Head hand over to Quality Control Head and inform to Quality Assurance Head.
- Quality Control chemist or above check the COA of received material with our specification and if the COA complies the specification, discuss with Quality Assurance Head and carry out the further process of testing, or if the COA does not match with specification, then inform to Purchase Head.
- Quality Control Head compare the test result with past trend and then inform to Quality Assurance Head.
- Purchase Head will send the soft copy of “Manufacturer Assessment Questionnaire for
  - API/Excipients (Refer Annexure No. 01)
  - Primary Packaging Material (Refer Annexure No. 02)
  - Secondary/Tertiary Packaging Material (Refer Annexure No. 03)
- to vendor for asking information.
- Filled manufacturer assessment questionnaire and test result will be received by Purchase department from vendor and handed to Quality Assurance Head.
- After reviewing the questionnaire and the test result the Quality Assurance Head decides whether to audit the facility or not.
- If it is decided to Audit the facility the purchase head discuss with the vendor and the date is fixed as per mutual understanding.
- Audit will be carried out as per by Audit checklist for
  - Excipients (Refer Annexure No. 04)
  - API (Refer Annexure No. 05)
  - Packaging Material (Refer Annexure No. 06)
- by minimum 2 person or maximum 3 person for 1 to 3 days.
- The audit team consists of Quality Assurance and either from Quality Control, Purchase, Production department as decided by Quality Assurance Head.
- Based on Audit report and compliance vendor will be approved or rejected and include in approved vendor list.
- As per recommendation of auditors and compliance report the Quality Assurance Head will take decision to re-audit the facility and decide the frequency i.e. minimum 6 months and maximum 3 years.
Vendors for New Materials (RAW MATERIAL AND PACKAGING MATERIAL)
- Purchase department search the vendor as per requirement by considering proximity, technical and commercial aspects.
- Production Head send the detailed specification of material IP/BP/USP/In-House as per requirement to purchase head. The purchase head will send to potential vendor through mail and ask them to send their specification with sample of three batches for raw material along with COA.
- Ask them to arrange “Open part of the Drug Master File” (DMF), TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy) free statement if derived from animal source whatever available/applicable and valid accreditation, for example, MHRA, EU, US-FDA,ISO,GMP etc as per their availability, representative sample of packaging material along with COA, TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy) free statement if derived from animal source.
- The vendor can be existing or new.
- The preference shall be given to existing vendors.
- Carry out pre assessment of new vendor on capability with the help of Heads Quality Assurance and Quality Control.
- As the material is new the purchase department also ask for working standard.
- After receiving the pre purchase sample along with COA the Purchase Head hand over to Quality Control Head and inform to Quality Assurance Head.
- Quality Control chemist or above check the COA of received material with our specification and if the COA complies the specification, discuss with Quality Assurance Head and carry out the further process of testing and if Quality Control department find difficult in testing can consult vendor, or if the COA does not match with specification, then inform to Purchase Head.
- Purchase Head will send the soft copy of “Manufacturer Assessment Questionnaire for
  - API/Excipients (Refer Annexure No. 01)
  - Primary Packaging Material (Refer Annexure No. 02)
  - Secondary/Tertiary Packaging Material (Refer Annexure No. 03)
- to vendor for asking information.
- Filled manufacturer assessment questionnaire and test result will be received by Purchase department from vendor and handed to Quality Assurance Head.
- After reviewing the questionnaire and the test result the Quality Assurance Head decides whether to audit the facility or not.
- If it is decided to Audit the facility the purchase head discuss with the vendor and the date is fixed as per mutual understanding.
- Audit will be carried out as per by Audit checklist for
  - Excipients (Refer Annexure No. 04)
  - API (Refer Annexure No. 05)
  - Packaging Material (Refer Annexure No. 06)
- by minimum 2 person or maximum 3 person for 1 to 3 days.
- The audit team consists of Quality Assurance and either from Quality Control, Purchase, Production department as decided by Quality Assurance Head.
- Based on Audit report and compliance vendor will be approved or rejected and include in approved vendor list.
- As per recommendation of auditors and compliance report the Quality Assurance Head will take decision to re-audit the facility and decide the frequency i.e. minimum 6 months and maximum 3 years.
- The material requirement specification provided to purchase Head should contain minimum following information :
  - Name of the Material,
  - Scientific Name, Molecular Formula
  - Material Specification with Grade (if material is Pharmacopoeial),
  - Material safety Data sheet,
  - Stability Information,
  - Category,
  - Additional In-house specification if any.
Existing Vendor Approval: (RAW MATERIAL AND PACKAGING MATERIAL)
- The current vendor shall continue to remain Approved, on the basis of their past performance and trend of result, unless the need arises for their re-appraisal. However, these will be re-audited at frequency around of 3 years.
- Incase of critical issue, re-audit at any time or stop purchase.
- The decision of Quality Assurance Head shall be final.
- The expected observations should be well within range only.

5.2 Considerations for Vendors Selection and qualification :

**Criteria** **for Vendors Selection and qualification**

For API:
- Purchase Head will search the vendor as per above criteria. (Criteria for Vendors Selection and qualification)
- Prior to Audit the purchase head will send the soft copy of checklist to vendor.
- The Auditors carry out the inspection of the manufactures facility by minimum 2 person or maximum 3 person for 2 to 3 days.
- The composition of auditors shall be from Quality Assurance and either from Quality Control, Purchase, Production department.
- Audit shall be carried out based on the guidance mentioned in the “Vendor Audit Checklist for API (Refer Annexure No. 05)”, but the audit may explore to other areas also based on the expertise of the individual auditor.
- Auditor,
  - Air Handling Unit
  - Water System
  - Production stages
  - Validation & Qualification
  - Process Control
  - Stability
  - Quality Control
- Vendor audit report shall be prepared within 15 days of the audit by the concerned personnel and shall be submitted to the manufacturers through Purchase Head.
- The manufacturer shall submit the compliance report within 15 days from the receipt of audit report. Follow up shall be taken from the authorized head or designee of quality assurance. If the compliance is not received within 30 days, the vendor shall be considered rejected and their rejection status shall be communicated to the concerned vendor.
- Quality Assurance Head or his/her Designee in consultation with the person who has audited the manufacturer shall take the decision for approval or rejection on the basis of vendor audit report and compliance report and incorporate the vendor in Approved Vendor List for API. (Refer Annexure No. 07).
- Based on recommendation of auditors and compliance report the re-audit frequency shall be decided minimum 6 months and maximum 3 years.
For Excipients:
- Purchase Head search the vendor as per above criteria. (Criteria for Vendors Selection and qualification)
- Prior to Audit the purchase head will send the soft copy of checklist to vendor.
- The Auditors carry out the inspection of the manufactures facility by minimum 2 person or maximum 3 person for 2 to 3 days.
- The composition of auditors shall be from Quality Assurance and either from Quality Control, Purchase, Production department.
- Audit shall be carried out based on the guidance mentioned in the “Vendor Audit Checklist for Excipients (Refer Annexure No. 04)”, but the audit may explore to other areas also based on the expertise of the individual auditor.
- Auditor,
  - Air Handling Unit
  - Water System
  - Production stages
  - Validation & Qualification
  - Process Control
  - Stability
  - Quality Control
- Vendor audit report shall be prepared within 15 days of the audit by the concerned personnel and shall be submitted to the manufacturers through Purchase Head.
- The manufacturer shall submit the compliance report within 15 days from the receipt of audit report. Follow up shall be taken from the authorized head or designee of quality assurance. If the compliance is not received within 30 days, the vendor shall be considered rejected and their rejection status shall be communicated to the concerned vendor.
- Quality Assurance Head or his/her Designee in consultation with the person who has audited the manufacturer shall take the decision for approval or rejection on the basis of vendor audit report and compliance report.
- Based on recommendation of auditors and compliance report the re-audit frequency shall be decided minimum 6 months and maximum 3 years.
- Include the name in approved vendor for particular item in Approved Vendor List for Excipients. (Refer Annexure No. 08).
For Packaging Material:
- Primary Packaging Material (e.g. PVC Film, Aluminum Film, Poly Bags etc.) Manufacturer are categorized as Vendors for Primary Packaging Material.
- Secondary / Tertiary Packaging Material (e.g. Containers, Cartons, Corrugated boxes etc.) & Preprinted Packaging Material (Leaflets or Inserts & Labels etc.) is categorized as Vendors for Secondary/ Tertiary Packaging Material.
- Purchase Head search the vendor as per above criteria. (Criteria for Vendors Selection and qualification)
- Prior to audit the purchase head will send the soft copy of checklist to vendor. (Refer Annexure No. 06).
- The inspection of the manufactures facility shall be carried out by the qualified person with help of vendor audit checklist for packaging material.
- Vendor audit report shall be prepared within 15 days of the audit by the concerned personnel and shall be submitted to the manufacturers through Purchase Head.
- The manufacturer shall submit the compliance report within 15 days from the receipt of audit report. Follow up shall be taken from the authorized head or designee of quality assurance. If the compliance is not received within 30 days, the vendor shall be considered rejected and their rejection status shall be communicated to the concerned vendor.
- Quality Assurance Head or his/her Designee in consultation with the person who has audited the manufacturer shall take the decision for approval or rejection on the basis of vendor audit report and compliance report.
- Based on recommendation of auditors and compliance report the re-audit frequency shall be decided minimum 6 months and maximum 3 years.
- Include the name in approved vendor for particular item in Approved Vendor List for Packaging Material. (Refer Annexure No. 09).

5.3 Disqualification of Vendor :

The vendor shall be disqualified and removed from the approved vendor’s list for the following reasons :
- If a batch does not comply with the specification with respect to critical tests then the vendor shall be disqualified.
- If a lot/batch does not comply with the specification with respect to minor tests then the vendor shall be disqualified if it is observed for 3 consecutive lots.
- 3 out of 10 lots failed to comply the specification in a year.
- The delivery schedule is not met for 40% supplies.
- Recommended by purchase department.
Inform to purchase department for disqualification through mail giving the reason. Consider order already placed.

5.4 Frequency of Updation of Approved Vendor list:

Frequency of updation for approved vendor list is 3 months. Do not make new list, if there is no addition and deletion.

6.0 ABBREVIATIONS:

Abbreviation	Expanded form
SOP	Standard Operating Procedure
Q.A.	Quality Assurance
Q.C.	Quality Control
API	Active Pharmaceutical Ingredient
GMP	Good Manufacturing Practice
COA	Certificate of Analysis
DMF	Drug Master File

7.0 ANNEXURES:

Annex. No.	Title
01	Manufacturer Assessment Questionnaire for API/Excipients
02	Manufacturer Assessment Questionnaire for Primary Packaging Material
03	Manufacturer Assessment Questionnaire for Secondary/Tertiary Packaging Material
04	Vendor Audit Checklist for Excipients
05	Vendor Audit Checklist for Active Pharmaceutical Ingredients
06	Vendor Audit Checklist for Packaging Material
07	Approved Vendor List for API
08	Approved Vendor List for Excipients
09	Approved Vendor List for Packaging Material