Responsible Person GDP Audit version 1

• Audit Title

• Document No.

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

MHRA WL

• The MHRA WL is up to date.

  Yes

  No

  N/A

Standard Operating Procedures

• Are SOPs created for the activities of the company?

  Yes

  No

  N/A

Document Control and SOP Creation and Maintenance

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Role of the Responsible Person

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Staff Training

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Site Security

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Warehouse Cleaning

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Breakages and Spillages

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Pest Control

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Temperature Control

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Verification of Supplier and Customer Status

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Procurement

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Receipt of Goods

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Counterfeit and Defective Stock

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Assembly and Despatch of Stock

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Transportation

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Return of Stock from Customers

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Disposal of Unusable Medicines

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Emergency Recall of Defective Medicines

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Record Keeping

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Complaints Procedure

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Self Inspections

• Does the SOP show responsibilities?

  Yes

  No

  N/A

• Does the SOP describe the process accurately?

  Yes

  No

  N/A

Bona Fide Checks

• Supplier and customer Bona Fide checks have been conducted with signed documents being available.

  Yes

  No

  N/A

Temperature Mapping, Monitoring and Control including Calibration

• Temperature Mapping has been conducted for both Summer and Winter within the last two years.

  Yes

  No

  N/A

• Temperature monitoring devices are within calibration date.

  Yes

  No

  N/A

• Temperature records have been completed in accordance with the procedure.

  Yes

  No

  N/A

• Where temperature excursions have been reported they have been documented and communicated to the RP with appropriate actions taken to ensure product is not affected or if so removed from saleable stock.

  Yes

  No

  N/A

Pest Control Records

• Pest Control contracts are available and are up to date.

  Yes

  No

  N/A

• Pest control records indicate that visits have been made in line with the contractual arrangement and where reported recommendations have been actioned.

  Yes

  No

  N/A

Product Recall Log

• The product recall log is up to date and where no real recalls have been required a dummy recall is recorded

  Yes

  No

  N/A

Training Records

• Training records are up to date.

  Yes

  No

  N/A

• GDP training has been conducted to all staff.

  Yes

  No

  N/A

Non Conformances and CAPA Records

• Non Conformances have been recorded.

  Yes

  No

  N/A

• Correction, Corrective or Preventive actions have been implemented and recorded.

  Yes

  No

  N/A

Overall Compliance to GDP

• Safe

  At Risk

  N/A