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SOP for Management of External Calibration/Validation Agency in Pharmaceutical Industry

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SOP

  1. Objective:

To lay down a procedure for evaluation and approval of external calibration/validation agency.

  1. Scope:

This SOP is applicable for all external service providers for calibration/validation     activities.

  1. Responsibility:

Engineering, Quality Assurance

  1. Procedure:

4.1. Engineering department shall identify the external agency based on        calibration/validation requirement and shall assess the type of service they provide.

Engineering department head or designated person from engineering shall inform quality assurance department for evaluation and approval.

4.2 Designated person from QA shall send the self-assessment questionnaire to external   agency.

4.3 Engineering and quality assurance department shall review the filled questionnaire.    Further information shall be requested from external agency if required.

4.4 External agency shall be approved by QA if questionnaire found satisfactory upon       review. QA department shall approve the external agency for 3 years.

4.5 QA department shall reject the agency if they found unsatisfactory upon       evaluation.

4.6 Contract shall be made with agency and its validity shall be 3 years. 

4.7 List of approved external calibration/validation agency shall be maintained by QA       department

4.8 Filled self-assessment questionnaire shall be retained by QA department.

  1. Abbreviations;

QA: Quality assurance

Annexures:

Annexure I- Self assessment questionnaire

Annexure II- Approved external agency list

 

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