Responsible Person Audit

• Audit Title

• Document No.

  Date

• Client / Site

• Conducted on

  Date

• Prepared by

• Location

• Personnel

Opening discussion, discuss agenda.

The Responsible Person

• Is there a current,signed agreement with the contract RP?

  Yes

  No

  N/A

• Is there an Organogram showing a reporting line to the Managing Director

  Yes

  No

  N/A

• Is there a document in place to show how the RP provides advice and what actions to take if the advice is ignored?

  Yes

  No

  N/A

Wholesale Dealers LIcence

• Are the head office details correct?

  Yes

  No

  N/A

• Are the contact details correct?

  Yes

  No

  N/A

• Are all sites included on the licence?

  Yes

  No

  N/A

• Are the RP details correct?

  Yes

  No

  N/A

• Are all product categories correct?

  Yes

  No

  N/A

Technical Agreements

• Are there Technical Agreements in place with all subcontractors , carriers, destruction agents etc?

  Yes

  No

  N/A

• Are the TA's periodically reviewed?

  Yes

  No

  N/A

Facility Tour - Purchasing

• Are bona fide checks in place for all vendors?

  Yes

  No

  N/A

• Is the bona fide status of all vendors checked regularly?

  Yes

  No

  N/A

• Are medicines only purchased from vendors holding a Wholesale Dealers Licence?

  Yes

  No

  N/A

• Are records of all purchase orders archived effectively?

  Yes

  No

  N/A

Facility Tour - Sales Order Processing

• Are bona fide checks in place for all customers?

  Yes

  No

  N/A

• Are bona fide checks checked regularly?

  Yes

  No

  N/A

• Are customer complaints recorded?

  Yes

  No

  N/A

• Is there a log of complaints?

  Yes

  No

  N/A

• Is the log reviewed regularly

  Yes

  No

  N/A

• Is there a process for product complaints?

  Yes

  No

  N/A

• Are sales order records archived effectively?

  Yes

  No

  N/A

Facility Tour - Goods Receiving

• Are deliveries unloaded in such a way as to protect the medicines from inclement weather?

  Yes

  No

  N/A

• Is there a process for reporting discrepancies / damages?

  Yes

  No

  N/A

• Are deliveries checked against a delivery note and the results recorded?

  Yes

  No

  N/A

• Are medicines requiring special storage conditions (e.g. Cold chain products or narcotics ) handled appropriately?

  Yes

  No

  N/A

Facility Tour - Order assembly and despatch

• Is stocked picked following strict stock rotation principles?

  Yes

  No

  N/A

• Are orders packed securely?

  Yes

  No

  N/A

• Are orders checked for accuracy prior to despatch?

  Yes

  No

  N/A

• Do despatch notes have all correct information?

  Yes

  No

  N/A

• Are products requiring special storage conditions (cold chain / narcotics etc) handled in an appropriate manner?

  Yes

  No

  N/A

• Are there suitable inventory checks in place?

  Yes

  No

  N/A

Facility Tour - Customer Returns

• Is there a process in place to approve the return of stock?

  Yes

  No

  N/A

• Is stock suitably segregated on return?

  Yes

  No

  N/A

• Is the stock checked against a strict list of guidelines to determine its fate?

  Yes

  No

  N/A

• Is the person making the checks suitably qualified?

  Yes

  No

  N/A

• Is the process for carrying out the checks done in a timely manner?

  Yes

  No

  N/A

• Is stock that may be resold returned to stock in a manner that maintains strict stock rotation rules?

  Yes

  No

  N/A

Facility Tour - Damages / Quarantined / Recall stock

• Is there a separate, suitably identified area for damaged stock? (including stock awaiting destruction)

  Yes

  No

  N/A

• Is there a process for handling quarantined stock which ensures that it may not be sold?

  Yes

  No

  N/A

• Is there a process for handling recalled product that ensures it is suitably segregated/identified and cannot be resold?

  Yes

  No

  N/A

• Is there sufficient space allocated for handling non-saleable stock?

  Yes

  No

  N/A

• Are all areas suitably identified?

  Yes

  No

  N/A

Facility Tour - Storage of product

• Is the storage area separate from other products to avoid contamination?

  Yes

  No

  N/A

• Is the storage area clean and tidy

  Yes

  No

  N/A

• Are cleaning records in place and up to date?

  Yes

  No

  N/A

• Is the area pest free?

  Yes

  No

  N/A

• Was the date of the last visit by the pest control contractor in line with the contract?

  Yes

  No

  N/A

• We're there any significant issues raised by the pest control contractor?

  Yes

  No

  N/A

• Are there any outstanding tasks, requested by the pest control contractor,for the client to carry out?

  Yes

  No

  N/A

• Is there an appropriate temperature monitoring process in place

  Yes

  No

  N/A

• Are the temperature records up to date and signed by a suitably trained person?

  Yes

  No

  N/A

• Have any temperature excursions been handled in line with a documented procedure?

  Yes

  No

  N/A

• Has the storage area been temperature mapped?

  Yes

  No

  N/A

• Are the sensors suitably calibrated? (annually, traceable to a national standard, accurate to +/- 0.5C)

  Yes

  No

  N/A

• For products requiring special storage conditions, is there an alarm system in place?

  Yes

  No

  N/A

• Is there a process in place to define the actions to be taken in the event of alarm activations?

  Yes

  No

  N/A

• Is the storage area secure?

  Yes

  No

  N/A

Quality system

• Is there a documented quality system in place?

  Yes

  No

  N/A

• Are the Standard Operating Procedures (SOP), forms etc controlled and approved formally ?

  Yes

  No

  N/A

• Are the SOP's periodically reviewed to ensure continued relevance?

  Yes

  No

  N/A

• Are the quality documents readily available to all relevant staff?

  Yes

  No

  N/A

Standard Operating Procedures

• Writing and controlling quality documents (SOP's, forms etc)

  Yes

  No

  N/A

• Archiving and Record Retention

  Yes

  No

  N/A

• Staff Training

  Yes

  No

  N/A

• Purchase Orders (including Bona Fide checks)

  Yes

  No

  N/A

• Sales Orders ( including Bona Fide checks)

  Yes

  No

  N/A

• Approving new customers

  Yes

  No

  N/A

• Customer Complaints

  Yes

  No

  N/A

• Product Complaints

  Yes

  No

  N/A

• Receipt of Goods

  Yes

  No

  N/A

• Order Assembly

  Yes

  No

  N/A

• Stock Rotation

  Yes

  No

  N/A

• Order Despatch

  Yes

  No

  N/A

• Damages / Quarantined stock

  Yes

  No

  N/A

• Customer Returns

  Yes

  No

  N/A

• Stock Destruction

  Yes

  No

  N/A

• Housekeeping and cleaning

  Yes

  No

  N/A

• Pest Control

  Yes

  No

  N/A

• Temperature Monitoring

  Yes

  No

  N/A

• Calibration of Sensors

  Yes

  No

  N/A

• Temperature Mapping

  Yes

  No

  N/A

• Handling Deviations - Corrective Action Plans

  Yes

  No

  N/A

• Site Security

  Yes

  No

  N/A

• Storage conditions in transit (inbound and outbound)

  Yes

  No

  N/A

• Recall of product ( including mock recall)

  Yes

  No

  N/A

• Batch Traceability

  Yes

  No

  N/A

• Counterfeit

  Yes

  No

  N/A

Job Descriptions

• Are Job Descriptions in place for all staff?

  Yes

  No

  N/A

Training

• Have staff been trained in the procedures relevant to their roles?

  Yes

  No

  N/A

• Have staff been trained in Good Distribution Practice ? (GDP)

  Yes

  No

  N/A