Audit

Opening discussion, discuss agenda.
The Responsible Person

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

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

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

Wholesale Dealers LIcence

Are the head office details correct?

Are the contact details correct?

Are all sites included on the licence?

Are the RP details correct?

Are all product categories correct?

Technical Agreements

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

Are the TA's periodically reviewed?

Facility Tour - Purchasing

Are bona fide checks in place for all vendors?

Is the bona fide status of all vendors checked regularly?

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

Are records of all purchase orders archived effectively?

Facility Tour - Sales Order Processing

Are bona fide checks in place for all customers?

Are bona fide checks checked regularly?

Are customer complaints recorded?

Is there a log of complaints?

Is the log reviewed regularly

Is there a process for product complaints?

Are sales order records archived effectively?

Facility Tour - Goods Receiving

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

Is there a process for reporting discrepancies / damages?

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

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

Facility Tour - Order assembly and despatch

Is stocked picked following strict stock rotation principles?

Are orders packed securely?

Are orders checked for accuracy prior to despatch?

Do despatch notes have all correct information?

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

Are there suitable inventory checks in place?

Facility Tour - Customer Returns

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

Is stock suitably segregated on return?

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

Is the person making the checks suitably qualified?

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

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

Facility Tour - Damages / Quarantined / Recall stock

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

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

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

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

Are all areas suitably identified?

Facility Tour - Storage of product

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

Is the storage area clean and tidy

Are cleaning records in place and up to date?

Is the area pest free?

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

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

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

Is there an appropriate temperature monitoring process in place

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

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

Has the storage area been temperature mapped?

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

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

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

Is the storage area secure?

Quality system

Is there a documented quality system in place?

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

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

Are the quality documents readily available to all relevant staff?

Standard Operating Procedures

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

Archiving and Record Retention

Staff Training

Purchase Orders (including Bona Fide checks)

Sales Orders ( including Bona Fide checks)

Approving new customers

Customer Complaints

Product Complaints

Receipt of Goods

Order Assembly

Stock Rotation

Order Despatch

Damages / Quarantined stock

Customer Returns

Stock Destruction

Housekeeping and cleaning

Pest Control

Temperature Monitoring

Calibration of Sensors

Temperature Mapping

Handling Deviations - Corrective Action Plans

Site Security

Storage conditions in transit (inbound and outbound)

Recall of product ( including mock recall)

Batch Traceability

Counterfeit

Job Descriptions

Are Job Descriptions in place for all staff?

Training

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

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

Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.