Audit Burden - Critical Factors for Suppliers - Pharmaceutical Technology
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Audit Burden – Critical Factors for Suppliers

Pharma companies want and have to qualify their suppliers to ensure their products’ high quality and safety for the patients. Whether it is a first-time audit or a follow-up audit, customers can evaluate if they can buy from a given supplier or have to look for another one. Suppliers, on the other hand, can show their high standards and the good processes they have. To be on the level of regulations is the critical point.

The audit preparation

All audits cover certain documents and key questions which suppliers have to prepare beforehand. These include but are not limited to SOPs, Batches of the product, product records, PQRs, yields, capacities, deviations, and supplier qualification. The supplier should organize their QMS well with fast availability of documents for the auditor, especially when it comes to remote audits.

Besides these documents, the supplier also has to prepare the parts of the facility the auditor will visit, like the warehouse, laboratory, and manufacturing plant. A regular day of work during the audit should be assessed. People and machines should be working for the auditor to evaluate.

At the facility

The key consideration during the audit itself is which employees a supplier (the auditee) has to allocate. The attending employees can vary depending on the company’s size. Every audit is accompanied by employees from the Quality department and Quality Assurance, like Quality Assurance Director, Manager, Office, or Technician. Additionally, there might be Regulatory First employees or the Technical Director. The profile of these people can be summarized as follows:

  • Usually have studied chemistry or pharmacy
  • Have specific skills to defend the site, like communication skills
  • Open and communicative
  • Might also be auditors for internal inspections

Furthermore, different departments and employees are involved in the audit during the factory tour. It is essential to have various profiles at the audit, and the feeling of them being knowledgeable of their field of expertise is highly appreciated by the auditor.

Costs and pain points

Although costs and pain points depend on the supplier’s size and the number of audits, three critical factors apply to a company of any size.

Time: Whether the company has a specialized team with dedicated time or not, an audit needs time to be prepared. In small companies with fewer audits, employees have to take time out of their day for the audit.

Facilities: Since a regular day of work is hardly achievable for security reasons, facilities are not working 100%. The reduced production is a cost factor.

Observations: When the auditor finds observations, measures have to be taken by the auditee to solve them. Solving the observations also costs money but is a necessary step in keeping up quality.

Opportunities

Even though an audit comes with significant resource requirements, it also provides valuable opportunities for a supplier. A good audit outcome is an opportunity for securing additional customers. Adding a positive audit report to a shared audit database, such as Qualifyze’s, allows customers to discover and qualify suppliers with minimal effort. This procedure can result in fewer audits at the site and less burden for the supplier.

Additionally, by being audited by a highly skilled auditor, the supplier receives the opportunity to improve their products, services, and way of working. Receiving audits can help to prepare for an inspection by authorities. In conclusion, capitalizing on new auditing practices offered by 3rd party auditing companies with highly skilled auditors, at the same time offering audit reports sharing and shared audits is an opportunity to offset the audit burden and turn it into a net positive for a supplier.