SOP for Qualification of Service Provider

A Standard Operating Procedure SOP for Qualification of Service Provider is essential in the pharmaceutical industry to ensure that external entities providing services meet the necessary quality and regulatory requirements.

This SOP for Qualification of Service Provider is to establish a systematic and documented approach for the qualification, selection, and ongoing assessment of external service providers to ensure that they meet the quality and regulatory requirements of the pharmaceutical organization.


To describe procedure for qualification of service provider.

SOP for Qualification of Service Provider Scope

The scope of this document pertains to qualification of service provider of Pharmaceuticals Ltd


  1. It is the responsibility of Procurement department and QA to execute this SOP.
  2. It is the responsibility of QA Documentation to prepare and update this SOP.
  3. It is the responsibility of QA to make certain that this SOP is followed in its entirety.
  4. It is the responsibility of Assistant QA Manager or Designee to review this SOP.
  5. It is the responsibility of QA Head or Designee to approve this SOP.
  6. It is the responsibility of Director Technical / Operations to authorize this SOP.

Definitions & Abbreviations

  1. Service Provider: Service providers refer to any outside firm / company that provide services to Pacific. This could range from qualification, calibration, validation, mechanical, and so forth.
  2. SOP: Standard Operating Procedure
  3. QM: Quality Management
  4. QA: Quality Assurance


  1. Once the service provider is selected, an “Initial Questioner” Form (QA/FRM/0000/00) along with “Qualification of Service Provider” Form (QA/FRM/0000/00) must be sent out preferably by e-mail, alternatively by post, requesting the Questionnaire and Forms to be filled and returned within 14 days.
  2. QA and Engineering are responsible to review both forms.
  3. Following review of the Forms, QA arranges via Engineering department for site audit of the service provider.
  4. A cross functional team made of the following individuals plan a visit the supplier on pre-approved date.
  • Engineering
  • Quality assurance
  • SOP for Qualification of Service Provider

Audit of Service Provider

  1. Audit of service provider is done using Service Provider Qualification Form (QA/FRM/0000/00).
  2. All documents and records must be checked during the audit.
  3. Training records of personnel as well as certification of competency for task to be performed including instrument and equipment calibration stickers must be verified.
  4. The audit evaluation is based on scoring using the Service Provider Qualification Form (QA/FRM/0000/00).

Risk Ranking for Service Provider

  1. Risk score for each risk category must be entered in the Form (QA/FRM/0000/00).
  2. The potential risk of service provider is decided on final scoring system.
  3. The scoring is based on the following system:
  4. Risk is LOW, if total risk score is > 23 (>75%).
  5. Risk is MEDIUM, if total score falls between 16 – 23 (>50%).
  6. Risk is HIGH, if total score is < 15 (<50%).
  7. Service provider with HIGH risk should stand disapproved.
  8. SOP for Qualification of Service Provider
  9. Service provider ranked as LOW risk is approved.
  10. Service provider with MEDIUM risk can be used only in case when the specified services are not available from any other vendor.
  11. Approved manufacturers are placed on the “Approved Vendor List of Service Provider” Form (QA/FRM/0000/00).

On Going Review SOP for Qualification of Service Provider

  1. Once a supplier is approved, the quality of services provided by them is monitored on a continuous basis in order to highlight any issues in providing quality services.
  2. Contract is reviewed on annual basis. In case of any deviation from the written contract, the contract will be terminated on immediate basis. Supplier will be blacklisted.
  3. Contract is re- awarded if the annual review is satisfactory.

Attached Documents (Forms / Annexure)

  1. Initial Questioner for Service Provider Form
  2. Qualification Form for Service Provider
  3. Approved Vendor List for Service Provider

Reference & Linked Documents

  1. SOP for Management of Documents
  2. Vendor Complaint Form
  3. Vendor Qualification Schedule

Approved Vendor List for Service Provider

Sr. No. Vendor Name Type of Service Contract Review Period / Annual Basis Status
Approved Date Conditionally Approved Date Rejection Date

Qualification of Service Provider

  1. Evaluation Date: __________________________
  2. Name of Service Provider: __________________
  3. Contact Person: ___________________________
  4. Designation: _____________________________
  5. Address: ______________________________
  6. Nature of Services to offer: ____________________
  7. Phone #: _______________
  8. Fax #: ______________
  9. E-Mail Address: ______________________


Description Points Score
How long the company has been in business? 1 point (0-5 Years)  2 point (5-10 years)  3 points (more)  
Is Company profile available? 1 point (if yes)  
How long Pacific has been dealing with the company? 1 point (0-1 years)  2 points (2-4 years)  3 points (more than 4 years)  
Clients list
Clients list For every well-known client use 0.5 point (maximum 2.5 points)
Customer Services
Does the company provide timely service?
  • 1    point for yes
  • 1    point for sometimes,
  • 0    point for no
Does the company provide the license from statutory bodies to provide specified services? 1   points for yes,         0    point for no
Does company has trained staff to provide specified services. Check training record? 2   points for yes,         0    point for no
Does company has specified instrument/equipment’s to carry out specified services? 2   points for yes          0   point for no
Does company have certificates of material used in providing services in Pharmaceuticals are verified? 1    points for yes         0    point for no
Does company has calibrated instrument to carry out services? 2    points for yes        0 point for no
Does company has MSDS of chemicals if any used in providing services 1      points for yes      0 point for no
Does the company offer competitive rates to carry out services? Does the company offer competitive rates to carry out services?
Status of Company (Satisfaction)
Has there been a particular problem with the company before either by egg Pharma Ltd or any other organization? On scale of 1 to 3 what is the level of satisfaction with the company

  • 3 very satisfy
  • 2 somewhat satisfactory
  • 1 dissatisfy
Quality Audit
Has the company got ISO certified? 2 points, for yes     0 point if no
Comment: Total Score: ______________

Possible points 31

  • If the score is > 23 (75% of total score): Approve Vendor
  • If the score is between 16 -23: Approve Conditionally
  • If the score < 15: Reject Service Provider

Approval Status: Approved Conditionally Approved Rejected

  • Remarks (if any): ___________________________
  • Evaluated by: _______________________________

Initial Questionnaire for Service Provider

Name of Service Provider
Contact person
Phone No.
Fax No.
Email Address
Service offered
Total year in service
Detail of Certification (if any)
Number of Skilled employees
Number of unskilled employees
Client List


Leave a Reply

Your email address will not be published. Required fields are marked *