SOP for Management of External Calibration/Validation Agency in Pharmaceutical Industry
To lay down a procedure for evaluation and approval of external calibration/validation agency.
This SOP is applicable for all external service providers for calibration/validation activities.
Engineering, Quality Assurance
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.
QA: Quality assurance
Annexure I- Self assessment questionnaire
Annexure II- Approved external agency list
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