GDP Audit Checklist

Is the content of the license/application accurate with the following: Procurement Holding/Storage Supply Export Contracted operation

Is the content of the license/application accurate with any medicines the company may handle in line with national legislative definition?

Have deficiencies from previous inspections been appropriately addressed in line with corrective/preventative actions (CAPAs) outlined in the company's response to previous inspection findings?

Are changes to operations that may affect the risk profile of the organization e.g. premises, equipment, computerized systems, subcontracted activities, key personnel, and products handled? 

Were changes managed in accordance with appropriate change control procedures?

Is there an appropriate procedure available?

Is there a log of change requests raised in the period since the last inspection?

Is there a classification in accordance with quality risk management principles?

Were the changes notified and approved by the relevant authorities if it was required?

Is an appropriate procedure defining deviation management available?

Is there a record of deviations raised in the period since the last inspection?

Is there a classification in accordance with quality risk management principles and appropriately documented?

Have appropriate CAPAs been taken to correct and prevent deviations?

Are any GDP-related activities outsourced?

Have the principles of quality risk management been incorporated?

How does the company initially approve a service provider?

Is there a system for monitoring and reviewing the performance of contract acceptors?

Is there an appropriate procedure available?

Is the outcome of the review documented and communicated internally?

Is there an appropriate procedure available?

Have the principles been incorporated into the company’s management of change, deviations, complaints, and outsourced activities?

Which processes identify risks to the quality of the product?

Is an organization chart available?

Is the number of persons involved in wholesaling operations adequate or appropriate for the GDP operations?

Are job descriptions available for key personnel?

Does the job description reflect the key responsibilities?

Have relevant personnel received initial and continuous GDP training?

Are training records available?

Are assessments conducted and documented?

Is there a program for regular periodic training in GDP?

Does the training program include aspects related to falsified medicinal products?

Is specific training provided related to temperature-sensitive products and controlled drugs?

Have personnel received training in SOPs relevant to their role?

Are assessments conducted and documented?

Is training provided in updated revisions to SOPs?

Is specific training provided pertaining to medicines handled, e.g. related to temperature-sensitive, hazardous, radioactive products and controlled drugs?

Is there an appropriate procedure in place covering health, hygiene, and clothing requirements?

Is there adequate lighting and ventilation in the storage areas?

Is access to storage areas appropriately restricted to authorized personnel?

Are rejected products, returned products, expired products, and recalled products physically segregated?

Do procedures require falsified medicinal products to be physically segregated?

Are products not authorized for the approved market physically segregated, even in cold storage areas?

Are these areas clearly identified and demarcated?

Are controlled drugs stored in accordance with national legislation?

Are radioactive materials and other hazardous products stored in accordance with national legislation?

Are the procedures and controls for the management of inbound and outbound goods appropriate?

Are radioactive materials and other hazardous products, as well as products presenting a special safety risk of fire or explosion, stored in accordance with national legislation?

Do receiving and dispatch bays protect products from prevailing weather conditions?

Is there sufficient space/capacity to allow safe storage and handling of products?

Are the storage areas appropriately maintained?

Are there cleaning procedures and records available?

Is there a pest control program in place?

Are pest control records available?

Are the rest, wash, and refreshment areas appropriately segregated from the storage areas?

Are the environmental conditions monitored and are such records available?

Has temperature mapping been conducted for the storage areas?

Where required by local legislation, is humidity monitored and equipment appropriately verified?

Were any hot spots or cold spots identified?

Are these locations routinely monitored?

Is there an appropriate procedure in place for handling/management of temperature excursions outside of predefined temperature limit extremes, and according to the written procedure? 

Have the temperature monitoring devices been calibrated within the intended operating range?

Is the continuous temperature monitoring data available?

Are temperature alarms installed and tested regularly to ensure adequate functionality?

Is there an appropriate procedure for handling temperature excursions?

Is there a backup system in the event of fridge/cold room failure?

Has temperature mapping been conducted for fridge/cold stores?

Are the temperature monitoring devices positioned in the appropriate locations to monitor the storage condition? 

Is there a program/schedule in place for planned maintenance?

Are maintenance records available?

Is there a program/schedule in place for calibration?

Are the calibrations traceable to national/international standards?

Are records of calibration available?

Are alarm/alert systems in place to highlight temperature excursions?

Are appropriate mechanisms or alarms in place to identify other deviations, where appropriate (e.g., automated equipment such as picking automation, A-frames, etc.) and how are these calibrated?

Is there such a system in place that can ensure the integrity of the product in the event of equipment failure? 

Is there a list of computerized systems available?

Are systems validated or tested?

Is user access restricted by role?

Is the computer system auditable?

Are detailed descriptions of the systems including diagrams available?

Are appropriate security controls in place to prevent unauthorized access?

Is access to stored data checked on a periodic basis?

Are appropriate backup procedures in place?

Is there an appropriate procedure for power loss and disaster recovery of data?

Has the company identified which equipment is required to be qualified and which processes to be validated?

Have principles of quality risk management been used to determine the extent of qualification and validation required?

Are the risk assessments available?

Are the qualification/validation reports available?

Have deviations been recorded and addressed?

Have the qualification/validation reports been completed and approved prior to the use of the equipment?

Are there criteria and appropriate procedures established for requalification and revalidation?

Is there an index of procedures available?

Are procedures approved and dated by relevant personnel?

Is version control in place?

Are the correct and current procedures available in the work areas?

Are procedures reviewed periodically? 

Are appropriate controls in place for the process of updating documents?

Are invoices available for purchases and sales?

Are delivery slips/orders available?

Are records stored in a manner to ensure they are protected from loss or damage?