Globally, one of the most highly regulated industries is the pharmaceutical industry. And rightly so, with strict regulations put in place to protect the rights and well-being of patients and end-consumers. This is why pharmaceutical companies must be highly diligent when purchasing materials and services and is why they only do so from high-quality suppliers that monitor their entire supply chain with rigorous attention to detail.
Audits, whether driven internally or externally, provide an opportunity for an independent assessment of chosen suppliers. Audits provide an avenue to review suppliers’ quality systems and overall compliance within their supply chain. They are essential to evaluate the capability of the supplier to consistently produce material or service of the required quality, the adequacy of production and control procedures, the suitability of equipment, facilities, and the effectiveness of their quality system in assuring the overall state of control. Therefore, an audit should be thoroughly planned and carefully structured to achieve its objective efficiently.
Which vendors to audit and in which order?
The complex nature of pharmaceutical manufacturing makes selecting which vendors to audit and in which order a complicated problem to solve. Pharma companies source many raw materials and services from external suppliers, and regulatory agencies, such as the FDA or EMA, are demanding more and more extensive supplier qualifications.
Solving this issue requires substantial knowledge and experience, which is why in the last couple of decades, a risk-based approach has been strongly encouraged by the regulatory agencies. Pharmaceutical companies need to periodically evaluate the risks associated with their suppliers in order to determine which ones have the greatest impact on the quality of their products.
To accomplish that, sponsors need a deep understanding of their procedures and how minor changes affect the product’s quality. Even though it is impossible to list all the risk factors that need to be considered, in the following paragraphs, some of the most common risk assessment inputs used for audit plan development will be discussed.
The type of operations performed at the supplier’s facility is the most critical factor. High-risk operations usually include sterile manufacturing, packaging and labeling, final product release, and excipient testing. These operations tend to have a higher degree of regulatory oversight and are therefore assigned a higher risk level. Therefore, suppliers that perform this class of operations should be prioritized.
When assessing the risk proﬁle of a vendor, several factors about its facility and equipment should be considered. These factors include facility design (compliance with cGMPs), maintenance, and equipment calibration. In addition, if past audits or regulatory inspections have identified problems with major systems (e.g., air handling systems/), this information should also be considered while assessing the facility’s risk profile.
The product class and formulation type may also influence the risk profile of a supplier. For example, manufacturing an intravenous (IV) formulation of a biologic is at a higher risk level than an oral tablet of a well-defined small molecule. Furthermore, information about the other products manufactured at the site will be helpful in developing the risk rank. As an example, a multi-product manufacturer producing products in multiple profile classes (parenteral, tablets, capsules, patches) have a higher risk of cross-contamination than a manufacturer producing a single profile class product.
If information about the company’s compliance history is available, it should be used for prioritization. That may include previous audit ﬁndings, timeliness in addressing those ﬁndings, and status of corrective actions. The site’s experience with health authorities is also a good indicator of compliance status. Furthermore, under the risk-based paradigm, the information about vendors should be as updated as possible. For example, a change in suppliers, regulatory issues, and product complaints may modify its risk profile.
It is essential to establish the reasons for the audit (e.g., new supplier, reaudit, recall investigation) and evaluate the auditee with a risk assessment in order to determine the audit’s type, scope, and specific objectives. There should also be a business benefit that is clearly stated to justify the cost. For example, this may be to satisfy the regulatory requirement that opens a new market or to gather information to justify reducing some analytical testing of raw material.
The QA department of the auditee should be contacted prior to the audit to allow adequate time for the agenda arrangement and the initial information gathering to occur. Given the sheer volume of audits that pharma suppliers receive, some may be reluctant to accept more of them. Preparation activities could include requests for pre-read material such as the quality manual, the site master file, GMP certificates, or even prior inspection reports.
Another major source of information is the pre-audit questionnaire, but it needs to be well constructed, and an expert auditor should carefully analyze the associated responses. That will allow the audit to properly concentrate on areas of uncertainty and perceived weakness, saving time, which benefits both the auditor and the auditee.
Auditor(s) should be aware of any sensitive issues, such as highly confidential information, and should any conflict arise during the audit, the auditor should handle it in a way that will not damage the relationship with the auditee.
Auditor selection for your audit plan
Because of the large number of suppliers that pharma companies use, there is an increasing need for performing audits in these companies. Only the biggest companies can afford a dedicated supplier auditing team, and even these well funded organizations have difficulties executing the audit schedule due to the sheer number of audits that need to be performed. Even though hiring more staff may seem the solution to this problem, this is an expensive and inflexible solution as the number of audits may vary a lot over time. Sometimes, there may also be a need to have specific in-depth expertise in areas that the internal auditor team may not have (e.g., when evaluating combination product operations such as an insulin injector pen). Lastly, language and geographical location limitations of auditors should be addressed as well. Most of the time, pharma companies have established partnerships with suppliers from other regions of the world. This makes the cost of travel and accommodation another barrier when it comes to performing all the required vendor audits.
Scheduling an audit
Estimating the time an audit will take may be an elusive task. A supplier audit could take much more time than expected due to a number of factors, such as a large number of records to review, difficulty accessing certain records or data, the complexity of the supplier’s operation, or a lack of transparency from the supplier. Additionally, if the audit is not thoroughly planned, the supplier may not be adequately prepared to provide the necessary documentation and information for the audit. These delays can lead to increased costs and missed deadlines.
How Qualifyze can help you with your audit plan
As we have discussed above, preparing and performing an audit is a complex, costly and time-consuming process. Working with a 3rd party audit provider like Qualifyze helps pharmaceutical companies organize, plan, schedule, and execute high-quality audits with their suppliers while minimizing the workload on their tables. We use our network of expert local auditors to minimize travel expenses and C02 emissions for companies while conducting audits in the local language of the auditee. From APIs, excipients, packaging can also place a request to audit a particular vendor by searching it by name and location on our platform. If there is an existing shared audit plan, you can choose to participate in it. If there is none, you can commission a new audit. The vendors we audit include manufacturers of APIs, Excipients, Packaging, distributors/shipping companies, software suppliers, and many others. Due to the higher reuse of quality data, the total number of supplier audits is reduced. That results in a significant cost reduction for the pharmaceutical company and the supplier.
The advantages of using our service to supplement your GxP audit program include the following:
- Reduces the number of full-time employees dedicated to the audit function without compromising the quality of your audit process or report.
- Provides access to a large pool of expert auditors, allowing us to select the perfect auditor for your audit, no matter the scope or standard required.
- Leverages the geographic location of auditors to maximize efficiency and minimize cost.
- Minimize the costs associated with travel and accommodation of the auditor.
- Mobilize auditors familiar with the local language/customs of the auditee to minimize risks surrounding miscommunication or potential cultural barriers.
- Flexible audits are easy to reschedule without disrupting employee calendars or internal teams (due to no internal travel needing to be coordinated).
- Easier supervision of problem sites and follow-up on corrective actions (CAPA review processes).
- Ensure that an impartial auditor will be reviewing the supplier.
- Standardizes your quality audit process by leveraging a dedicated quality team to oversee the preparation, execution, and report development process of your audit.
Get in touch to discuss how Qualifyze can help you streamline your audit plan for 2023 today!