The auditor has a very important responsibility to go over all the processes and accurately report the audit findings. An audit should not be perceived as an attack on the auditee’s systems; however, it should be perceived as an opportunity to improve one’s system. During the audit, the auditor is to remain ethical, open-minded, diplomatic, observant, decisive, versatile, self-reliant, open to improvement, sensitive to different cultures and cooperative. An audit is performed in order to ensure that the auditee is compliant with the GDP guidelines; any faults within the auditee’s quality system are identified and improvement suggestions are given, however, the good quality aspects are also to be highlighted and praised. If the auditee is made to feel confident rather than attacked, they will be more open-minded to the auditor’s improvement suggestions and might agree to provide a more in-depth look into their system, therefore the auditor will be more successful in obtaining a true picture of the company and producing a very detailed audit report.
Prior to conducting the audit, the auditor must ensure that all the necessary preparations are done. These include preparing the audit agenda, briefly researching the auditee prior to the audit, understanding the scope of the audit (ensuring that if the client would like to have a particular focus on a particular process, this is given priority), preparing all the required documentation in preparation to take structured notes (this will be very beneficial at the end when the auditor will be writing the audit report) and preparing the template for the audit close-out meeting. While preparing the audit agenda, the auditor is to ensure that sufficient time is allocated to each area. Normally, the audit is executed by first having an introductory meeting, where the auditor and auditee meet each other and a presentation is given by the Auditee. This presentation is very important as it gives an insight to the auditor with regards to site capacity, number of employees, company’s objective, history, quality policies and activities. After this presentation, the audit will progress to a site tour of the facility. This tour is critical as it gives the auditor the opportunity to see first-hand how the company is operating. Once the tour is finished, the auditor moves on to review the company’s Quality Management System (QMS) documentation. Once this part is also concluded an audit close-out meeting is held, where a brief summary is given by the auditor with regard to the audit findings.
On the date of the audit, it is important that the auditor is prepared and focused. Once the auditor arrives at the auditee site and the introductory meeting is held, the auditor goes over the audit agenda with the auditee to see if the auditee would like to make any changes. If there are no changes, the audit proceeds with the company presentation by the auditee and the facility tour. In a GDP audit, the site tour would mostly consist of a tour of the warehouse. During this tour, the auditor would look for management, points such as consignment segregation, Enterprise Resource Planning (ERP) software, abelldocumentation, temperature mapping of the warehouse, temperature and humidity control/monitoring, pest control, security, cleanliness, etc.
When a consignment is received (goods in) it should be placed in a secluded area labelled as ‘Quarantine’. The consignment is to remain in this area until it is validated and confirmed that it can move to the next step for dispatch. Once this is confirmed, it can move into the ‘Released’ area of the warehouse. Segregation through the ERP System is also acceptable in lieu of physical segregation. There should also be a ‘Rejects cage’ within the warehouse for products that have expired/been returned and are meant to be sent for destruction. Having segregated areas is important to avoid mixing up products/consignments. If the company makes use of an ERP system, it is important to ensure that the system has been validated. The validation documents are reviewed and the system is explained to the auditor. If the company makes use of a paper-based system, it is important to ensure that there is proper document control.
Temperature and humidity are very important; it is important to ensure that both temperature and humidity are maintained throughout the supply chain, including storage and transport. Temperature mapping is performed in the warehouse ideally during the hottest days of summer and the coldest days of winter, in order to take both temperature extremes into consideration when planning the storage of the products. The warehouse should also have dataloggers, placed in worst-case positions in order to measure the temperature and humidity. If there is a temperature excursion the responsible people should be notified and a deviation must be opened to check what led to this excursion. The client should be notified with regard to any temperature excursions that might have an impact on the product, as per Quality Technical Agreement requirements.
It is very important that the facility is secured and that only authorized personnel can access it. Pest control is also a very important part of the audit. It is important to ensure that the product is protected from all aspects that could affect its quality or integrity. Transportation vehicles are also checked to ensure that they have proper temperature controls and adequate locks to prevent theft.
Once the tour of the facility is concluded, the auditor starts the review of the documents within the QMS. Due to time constraints, it could be the case where not all the documents are reviewed; in this case, the auditor might ask for some documents to be sent via email or a secured link to review after the audit. The purpose of this is to ensure that all the relevant processes are being implemented and any gaps are identified in order to build a more robust system.
Important documents which are reviewed would include temperature mapping, vehicle qualification, ERP system validation and several Standard Operating Procedures (SOPs) such as document control, deviations, outsourced activities, recalls, complaints, falsified medicines, quality risk management, training, etc. During the review of SOPs, supporting documentation can be requested by the auditor in order to ensure that the process is being followed. An example of this would be, when the auditor is reviewing the Recalls SOP, the guidelines state that if there were no recalls throughout the year a mock recall should be held (this is also to be stated within the SOP) therefore, the auditor might ask for the mock recall from the previous year and ensure that all the steps performed are in line with what is written within the procedure.
When the review period is concluded, the auditor is allowed time to gather all the points listed throughout the day in order to give a brief summary to the auditee during the close-out meeting. During this meeting, all the audit observations are discussed with the auditee without being given a classification (Critical, Major, Minor or Recommendation). Once the audit is concluded, the auditor will write the audit report, listing all the observations with their relevant classification (Critical, Major, Minor or Recommendation) and this is sent to the auditee within 30 days.
Once the audit report is sent to the auditee, the auditee has 30 days to reply to the observations with their Corrective and Preventive Action (CAPA) plan. This plan is then reviewed by the auditor and a reply is formulated and sent to the auditee. The reply can be that there are no further actions and the auditee has successfully replied to the observations or it can be that further information is required to conclude the audit.
It is important that the observations listed are with reference to the “Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use.” This will also help the auditee to have a better understanding of the guidelines and what is expected with regard to maintaining the product’s quality and integrity.
