1. Tell us about when and how EMD Millipore decided to undergo the EXCiPACT™ audit?
EMD Millipore is very active in the field of APIs and excipients and has been a member of several industry associations for many years (such as IPEC Americas, IPEC Europe, European Fine Chemicals Group EFCG, and others). These associations together with others developed EXCiPACT™as a program to ensure excipients are manufactured according to best practices. There are no legally binding regulations in Europe or the US on GMP for excipients but there are voluntary standards. The idea was to create something where the supplier can really prove that excipients are manufactured according to best practices. EXCiPACT™ is a further development of the IPEC/PQG Guideline on Good Manufacturing Practices for pharmaceutical excipients and the IPEC Guideline on Good Distribution Practices for pharmaceutical excipients, combined with a very high quality certification scheme. Therefore, it was a logical step to participate in the pilot phase of the EXCiPACT™ certification program in order to reach the next level.
With the certification scheme, we have recognized standards for suppliers and users and we also have a tool that combines evidence of compliance, mitigating the burden of customer audits. The excipient supplier can now prove implication of GMP and provide customers with an EXCiPACT™ certificate plus the audit report. Ultimately this saves time and money for both sides.
2. First launched last year, the audit took quite some time to execute. What did the thorough assessment process entail?
To start with, anyone can freely download the expectations on excipact.org. We downloaded the standards, read through them, then made an evaluation. We performed a gap analysis by listing the standards on the left and our own quality menu on the right, and then asked: “Are we compliant? Are there any gaps we need to close?”
After getting clarification, we went back to the EXCiPACT™ website to see which third party auditing companies perform audits on their behalf. We contacted one of these companies and made a kind of pre-audit.
In summary, the auditing company makes a step one audit to see if all the necessary documentation needed according to the EXCiPACT™ standard is available. This is followed by a step two comprehensive certification audit. We then received an audit report, responded to the audit report, and a certificate was issued by the certification board of the company that audited us.
The overall scheme of EXCiPACT™ was launched in January 2012. Following this, EXCiPACT™ established all necessary processes. EXCiPACT™ is a non-profit organization and does not have its own auditors, meaning it had to qualify auditors and third-party auditing companies to be approved to perform audits on their behalf. Through its organization of volunteers, all the processes were put into practice. This meant they had to write the standards and the guides, as well as organize everything properly. It took time before the companies were approved as EXCiPACT™ certifying companies as the individual auditors and auditing companies had to undergo an approval/auditing process. The auditors had to prove formal qualification in professional training, university degrees, and so on. They had to pass an EXCiPACT™ training, which is a two-day, face-to-face training. After the potential auditing companies had proved that their internal system would comply with the requirements of EXCiPACT™ auditors, the pilot-phase started with auditing companies for EXCiPACT™ certification. The time leading up to the first audit of excipient suppliers was very busy for the EXCiPACT™ organization. The first audit was conducted at the end of February 2013 and EMD Millipore was audited in March 2013 as the second company ever audited by EXCiPACT™.
3. How can EXCiPACT™contribute to time and cost savings for pharmaceutical companies?
Auditing is a time and cost-demanding process for the auditors, pharmaceutical manufacturers and the auditees. Excipient suppliers receive a great deal of audits. We made a calculation on the savings for both the supplier of excipients as well as the user.
An EXCiPACT™ audit would take three to four man days, depending on the size and complexity of the audited site; at the most it would take six man days.
Taking into consideration that typically an auditor costs around about $2,000 per day, we calculated this would total around $13,000 per location. On top of this, the EXCiPACT™ organization charged a certification fee of $7,150. EXCiPACT™ requires re-certification every three years so there are also annual surveillance audits. This would add up to another $6,500 per year making the Total Expense on the supplier side over three years an estimated $33,000.
With one 2-day audit per month, plus days of preparation and internal cost we calculated in the case of the EXCiPACT™ audit, we are saving $40,000 per year, meaning a total of $120,000 in three years based on having one less audit per month. So you have a total investment of $33,000 and a total saving of $120,000. Based on this model, the excipient supplier will save $87,000.
Looking on the side of pharmaceutical companies, if more of their suppliers would have an EXCiPACT™ audit they would also save one, 2-day audit per month, plus three days travel and preparation, equaling an annual saving of $79,000 -- meaning a total saving of $237,000 over three years.
4. What are some best practices for excipient manufacturers to ensure quality?
EXCiPACT™ is an excellent model and process. There are clearly defined requirements on appropriate GMP and GDP for excipients. This basis can be easily shared with your customers. The auditors challenge what you’re doing, potentially opening your eyes to any issues.
Another important thing to note is the auditing process itself. The auditors are very highly qualified. EXCiPACT™ has very high expectations so auditors are extremely well-educated and knowledgeable professionals. The organization fully understands that the quality of an audit depends 100% on the quality of the auditor.
5. How will this certification movement shape the future of excipient manufacturing and distribution?
This is a difficult question and my assumption is that companies will quickly become aware of the EXCiPACT™ standard and certification. In the future, it will take time for everybody to understand the concept and see the benefit, but I predict that many companies in the pharmaceutical arena will be EXCiPACT™ certified.
I’m 100% convinced that EXCiPACT™ is the right thing for the pharmaceutical excipients industry and also for our customers. We’re moving in the right direction and I hope the acceptance of EXCiPACT™ will be substantial in the community and supply chain.