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.

Purpose

SOP for Qualification of Service Provider Scope

Responsibilities

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

Procedures

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

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: ______________________

HISTORY:

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