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How to Conduct Supplier Audit in Pharma Manufacturing — A Checklist
In order to provide your customers with the products they need, your pharma manufacturing business needs suppliers. But how do you know that these supply partners are the best possible fit for your business, and how do you make sure the relationship is the best it can be? With a supplier audit.
Follow our checklist and make sure that your supplier audit is ready for action, and keep on delivering the very best to your customers.
What sort of quality indicators are you looking for?
Define ahead of time what sort of thing you are looking for from your audit. Consider:
- Regulatory certificates
- The chain of custody of raw materials used
- The process used for batching materials
- Internal production records
- Product specifications
Where will you look for these indicators?
Where are you going to find these indicators? You may need to examine:
- Customer complaint and feedback records
- Documentation from the manufacturing process
- Production history records, including any missing documentation or anomalous documents
- The history of the supplier’s deliveries to your pharma manufacturing company
- Testing and inspection processes ahead of the release of each batch
- Storage and loading records for batched ingredients and components
Have you done your research?
Never go into a supplier audit blind. Yes, you have worked with your supplier probably for quite some time and therefore you know quite a bit about what they do. However, you still need to arm yourself with information ahead of time.
Consider:
- The history of the supplier
- Any historic auditing reports you have access to
- Your company’s history of using the supplier’s products and materials
- Any competitors of the supplier who could provide an alternative deal
- Any other information you can find on the supplier
This research does not replace any of the auditing work that you and your team have to do, but it does support positive outcomes from the project, as well as the best possible insight overall.
Have you conducted digital investigations?
We are well and truly living in the data age, which means we have much more research potential at our fingertips.
All suppliers — in particular, well-established suppliers — will have a digital trail that is found online. Take some time to research this. Take a look at customer reviews and other bits of digital information that are found online, and use this to enhance your existing research.
The FDA website also features resources that you can use to conduct investigations.
Again, this is not designed to replace your auditing work but to enhance the benefit you will receive during the audit.
Have you taken customer opinion into account?
What do your customers think of the products you are offering to them? What are the key pain points or areas of dissatisfaction? Asking these questions can give you a solid basis for your audit.
Start by analyzing all the complaints that can be traced to product components from this specific supplier. Then you can conduct your audit based on this, investigating how the practices of this particular supplier may be causing complaints or quality concerns.
For pharma auditing, this is particularly important. Whether you are operating in a market overseen directly by the FDA or working in a broader ISO environment, it will be your responsibility to handle all consumer complaints and quality control issues in the right way.
This includes investigating their source and compiling a report of any possible errors on the part of the supplier. It may be worth speaking to other customers of the supplier to find out if anyone else has any experience of problems with this supplier — even if the problems lie outside your particular product range.
Do you know the set-up of the supplier?
This is very important. You need to know exactly who you are dealing with when you purchase ingredients or components from a supplier. If the supplier is outsourcing any part of the production or the supply of their own ingredients, you need to know about this, as you may need to audit this outsourced partner too.
It is to be expected that your supplier will have partnerships in place with other companies in the pharma industry. These partnerships may involve supply, or they may be focused on strategic operations — whatever the set-up, the supplier you deal with needs to be totally transparent at every stage.
Your supplier does not disclose any such partnerships and does not give you the details you need. This is a major red flag. If you are to build a positive, ongoing relationship with a supplier, you need to be able to trust in what they tell you. Make sure you know how the supplier operates ahead of time, so you can compare your findings.
Who is in control of the audit?
This brings us neatly onto the final point in our checklist — who is in control of the audit?
Of course, the answer to this question should be you. You should be in the driving seat, able to collect all of the data and information you need to complete your assessment. The supplier should be happy to permit this and should keep nothing back from you. There should be no intentional or unintentional clouding of the truth.
If you feel that your supplier could do more to help you with your audit, let them know. Most suppliers will be happy to help you with this.
If you feel that your supplier is intentionally trying to impede your progress, this is a serious issue. You need to raise this with them and consider looking for another supplier.
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Supplier audits are important if you are to achieve a positive network of partners and if you are to meet the ongoing needs of your clients. Use this checklist and make sure that your audit does the job.