Vendor audits in the pharmaceutical industry may be perceived to be a burden for some vendors and a resource drain for the pharmaceutical companies, they are valuable and necessary processes meant to benefit both. This is especially so when dealing with life-saving medications.
An audit is a method used by not only pharmaceutical companies but most large companies as well. The goal is to inspect and evaluate a vendor’s quality management system (QMS), as well as its overriding practices, product handling and data integrity of all relevant documentation.
In an industry required to be more regulated than any other industry in the world, quality and adherence to predetermined standards is not an option. Lives depend on it.
In an industry required to be more regulated than any other industry in the world, quality and adherence to predetermined standards is not an option. Lives depend on it.
Close and prudent assessment of a vendor’s qualities and practices has evolved from ever-changing quality control standards, where quality control is a necessity, not a luxury.
The auditor is a neutral body. They are commissioned to find a specific set of results and to see that the vendor meets the criteria and standards they have been given. They are then expected to deliver a comprehensive report on their findings, with specific recommendations and actions.
Most audits are conducted on-site by a team – each member has a specific expertise. On-site activities are scheduled so the appropriate vendor resources are on site to ensure the overall process is expeditious and follows all protocols.
What Do They Look For:
There are specific areas of compliance that are reviewed:
• Is the vendor equipped to meet all required standards?
• Is the senior management of the vendor company responsible and committed to the standards required?
• Are the vendor systems accurate, well maintained and do the audit results meet all criteria?
• Is the vendors’ data handling above the standards?
The goal of any vendor audit is to assess the quality management of the entire organization, through its procedures and processes.
Quality control is assessed based on the efforts taken by the vendor to ensure their products and services meet all needs to conduct business and process transactions. As well, all computer systems that are used by the vendor to conduct business will be assessed and tested.
Related: Preparation for GMP Audit in Pharmaceuticals
Related: Preparation for GMP Audit in Pharmaceuticals
What are the Benefits to being Audited:
For the pharmaceutical companies, it allows them to assess vendors across a fair and level playing field. As well, they have assurances their products and information are being handled responsibly and all liability and risk are minimized.
For a vendor, it allows them to improve efficiencies and their internal processes and protocols. It also allows them to show other pharmaceutical companies or suppliers they can work within strict standards and adhere to them.
As well, the vendor will benefit from all previous audits done with other vendors – as those learnings will be carried to them by the auditors.
Risks of not being Audited:
With no audit done, a vendor risks limiting with whom they can do business. They also expose themselves to liable actions should their standards or protocols not be up to standard. Having to endure multiple independent audits by each of their suppliers will consume a lot of the vendors’ time and resources.
Vendor Audits in the pharmaceutical industry are very necessary, will benefit all parties and will ensure the standards are maintained during manufacturing of the product.
Related: Download Vendor Audit Checklist
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