FAQs

General FAQs

Q&A of webinar held on 21st Nov 2013 “Qualifying pharmaceutical excipient suppliers: the role of EXCiPACT”

 

General FAQs

What is the EXCiPACT certification scheme?

The EXCiPACT Certification Scheme is a credible, high quality, 3rd party international certification scheme for manufacturers, suppliers and distributors of pharmaceutical excipients. The Scheme is owned and managed by EXCiPACT asbl, Brussels and is delivered by EXCiPACT-approved 3rd party Certifying Bodies employing EXCiPACT-registered auditors.

Developed by suppliers and users of excipients, the Scheme comprises the following:

  • GMP Standards for excipients (either EXCiPACT GMP annex to ISO 9001:2008, or NSF/IPEC/ANSI 363-2014 GMP- includes requirements of ISO 9001:2008)
  • GDP Standard for excipients (EXCiPACT GDP annex to ISO 9001:2008)
  • Certifying Body quality system definition and qualification process
  • Auditor Competency definition, training course, exam, and registration process

Audit & Certification Steps and Duration?

The following steps to Certification need to be taken and an estimate of the duration is indicated, but this will vary depending on the excipient supplier, their GMP compliance and any corrective and preventive actions they may need to put in place following the EXCiPACT audits.

  • Agree Stage 1 and Stage 2 audits with an EXCiPACT Registered Certification Body
  • Stage 1 Audit to determine preparedness of organisation and Stage 2 Audit duration. A date for this could be several months in advance from the initial contact with the Certifying Body, and may depend on auditor availability.
  • Stage 2 Audit – full certification audit. This should happen with a gap between it and the Stage 1 audit, an interval of a minimum of 4 weeks would be expected, but the timing of the audit after the Stage 1 may depend on the conclusion of any identified non-conformities in the Stage 1 audit, especially is these are classified as Major or greater.
  • Submission of audit report and review by the Certification Body Certification Board. This varies by Certification Body but we would anticipate that it should take around 4-6 weeks.
  • Certification decision and notification to EXCiPACT, issue of Certification Fee Invoice to certified excipient supplier – another 2 weeks
  • Receipt of Certificate fee from excipient supplier and addition of their name to EXCiPACT website – between 2-3 months depending on the policies of the organisation for paying invoices (60-90 days).
  • Publication on the EXCiPACT Website as an EXCiPACT Certified supplier would then follow.

From start to finish we would expect the entire Certification process to take approximately 6 months on average.

 

Our excipients production facility has frequently been audited by customers already. What are the advantages of undergoing an EXCiPACT audit?

The Falsified Medicines Directive in Europe places express requirements on your customers to assess the GMP used in the manufacture and GDP used in the distribution of your excipients. This requirement applies to ALL your European customers. What proportion of your existing pharmaceutical customer base currently audits you? All those customers who do not currently audit you will be able to use your EXCiPACT audit report instead of commencing their own audit programmes.

There are similar requirements from the FDA in the USA,…

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How do I know that the audit report has not been tampered with by the excipient supplier?

You will be able to contact the 3rd party audit organisation and request that they verify the authenticity of the audit report. This will allow you to confirm it is the same as the one they issued to the excipient supplier.

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Will an EXCiPACT certificate be recognised by authorities?

The FDA have indicated in their strategy document that they need to work in partnership with 3rd parties to secure the pharmaceutical supply chain. They have quoted EXCiPACT and mentioned it several times in public meetings as being a suitable scheme to meet this intent: to aid security of the supply chain. It has to be remembered that an audit is not the only issue an excipient user has to address when qualifying a new supplier.

Similarly in Europe the UK’s MHRA has stated that they could not see how a 3rd party certification scheme could be effective if it was not structured like EXCiPACT – with EXCiPACT taking control of the oversight of the 3rd party auditors.

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Is an EXCiPACT certificate a substitute for a regulatory inspection?

No. But regulatory inspections of excipient suppliers are at present rare and usually not a matter of routine.

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How does the EXCiPACT Standard differ from the IPEC-PQG GMP Guide for excipients?

The IPEC-PQG GMP Guide for excipients introduces the reader to the principles of GMP and how they can be applied to the supply of excipients. It includes examples and detailed practices which are designed to help the reader understand GMP (likewise the IPEC GDP Guide for excipients performs the same function in regard to GDP). Or, in other words, the guides are “How to do” documents.

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Would EXCiPACT report an adverse situation discovered during an audit to authorities?

EXCiPACT includes the definition of a situation which is called “life threatening”. Such a situation would be expected to lead to real end patient risk of harm. It is an express part of the agreement with 3rd party audit organisations…

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Can I dispute the audit findings and what if I do so?

The 3rd party audit organisation will have a dispute procedure in their agreement with each supplier (check there is one). If you are unable to resolve the dispute with them, then an appeal is possible to EXCiPACT.

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Is confidentiality of the audit information ensured?

There will be a confidentiality agreement between a supplier and the 3rd party audit organization.

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Will EXCiPACT make it needless for a pharmaceutical manufacturer to conduct own audits of excipients suppliers?

An EXCiPACT certificate and attendant audit reports is an indication that the supplier meets the minimum GMP and or GDP requirements for excipients. It follows that some users may have more demanding requirements for GMP and GDP and so may still require a formal and separate audit.

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As a pharmaceutical manufacturer I would like to benefit from audit sharing. How can I access  a certain audit report? From EXCiPACT, the 3rd party audit organization or the supplier?

EXCiPACT audit reports will be available directly from your suppliers who have had successful EXCiPACT audit assessments from EXCiPACT approved 3rd party audit organisations.

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Can I really rely on an EXCiPACT Certificate or do suppliers easily obtain such certificate when cooperating with EXCiPACT?

An EXCiPACT certificate and attendant audit reports is an indication that the supplier meets the minimum GMP and or GDP requirements for excipients. Great care has been taken to ensure that EXCiPACT approved 3rd party audit organisations only employ auditors who meet the EXCiPACT auditor competency requirements. This oversight by EXCiPACT will ensure that audits are consistent, thorough but fair.

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In case my excipients production facility has been subject to an EXCiPACT audit, does everybody have access to the audit report who is interested or who pays for it?

It is entirely up to a supplier to  decide with whom they share their EXCiPACT audit report.

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Will the EXCiPACT audits be performed by qualified auditors?

Yes, all EXCiPACT-approved 3rd party audit organisations will only employ auditors who meet the EXCiPACT auditor competency requirements.

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What does an EXCiPACT audit cost per product and per site?

EXCiPACT audits only assess the management system of the excipient supplier. EXCiPACT certification would not be applied to specific products. The cost of the assessment would, therefore, apply to the named location on the scope of the certificate and be dependent upon the complexity of operations on that site.

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Why does EXCiPACT charge a Certification Fee to excipient suppliers?

The EXCiPACT Association apply strict oversight to the 3rd party Certifying Bodies and their auditors who perform the audits of excipient suppliers. These oversights for the Certifying bodies include:

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Why does the Certifying Body conduct a pre-audit (Stage 1) before the full audit of the excipient supplier (Stage 2)?

Best practice in Certification Audits is to conduct the audit of the supplier in 2 stages. This is detailed in ISO 17021 Conformity assessment requirements for bodies providing audit and certification of management systems.

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Q&A of webinar held on 21st Nov 2013 “Qualifying pharmaceutical excipient suppliers: the role of EXCiPACT”

 

Are there any clear regulations for this requirement in ASIA region?

Not that we are aware of. However the principles of supplier qualification are common in all regions that we are aware of and that there is an expectation that the supplier has been assessed for compliance with the principles of GMP. I would expect Australia (New Zealand) to be very similar to Europe and the US in this respect because of their close links with those regions. Japan will be different because the legislation there is quite different to the rest of the world and excipients already have some direct regulatory authority oversight. China is also developing approaches to excipients that meet local needs and behaviours and is again likely to be different

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Do audit reports refer the name of all excipients under scope?

The Scope of the Audit should be clearly stated on the EXCIPACT Certificate, and in the audit reports. Those parts of the facility within scope (i.e. excipients) should be made clear. Please see the website (www.excipact.org) for the guidance document on this subject.

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Is there an expectation that any observations from the Excipact audit report have a corrective action response?

Yes any identified actions need to be addressed with a corrective/preventive action plan (CAPA). This should be re-visited and checked at the next audit to verify all actions have been addressed and closed out. In the case where Critical findings are identified then a further separate audit may be required to verify closure before the next audit is due. If a Critical finding is identified any supply should be ceased until the issue is resolved.  It is expected that these corrective/preventive action plans and any letter accepting them from the Certifying Body are included with the audit reports provided by the supplier.

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Do authorities agree on this system. Do they recognize certification + report or only the certificate is enough?

EXCiPACT has kept the European and FDA fully updated on the design, development and realisation of the Scheme over the past 5 years. The recently published Guideline to ascertain the GMP required for excipients makes express reference to “certification held by the supplier” as a means of them demonstrating the GMP (GDP) that has been implemented. Secondly the MHRA and FDA attended the European EXCiPACT launch event in Barcelona in 2012 and the FDA at the US launch event in Baltimore in April 2013. It is very clear they see scheme as value adding to all parties (including themselves) when used as one part of excipient supplier qualification.

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What are the grade (Pharma, USP/NF, etc) requirements for excipients used in OTC products in the US?

If a supplier makes a claim their product is USP/NF compliant then there is an expectation that the excipient has been made in accordance with USP <1078>. This informational chapter is effectively identical to the IPEC-PQG GMP Guide 2006. As EXCIPACT uses all of that guide in the definition of GMP in its standards, it follows that an EXCiPACT™ GMP Certified manufacturer would comply with the requirements too (note USP monographs would be for APIs).

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What is the cost for to a company that wants to see this certificate from the supplier?

EXCiPACT makes no recommendations nor places any limitations on how the excipient supplier provides the Certificate and audit reports to their customers. It is a decision for each supplier how they want to do this.  Bear in mind that the supplier may wish to redact any commercially sensitive or confidential information from the audit report.

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I have a query about how an EXCiPACT report bridges to the recently published EU GMP for excipients. As I read this, the MA holder’s assessment is in part a risk based and this must be a product by product case, rather than site based? Any thoughts?

Supplier qualification covers many steps, not least the quality management systems and GMP and / or GDP applied by the supplier which is what EXCiPACT covers. There are other steps too including as you point out verification that each excipient is suitable. The supplier will also have to provide more information about the excipient to allow the excipient user to conduct their own assessment (e.g. TSE, residual solvents, elemental impurities and so on statements and data). Nevertheless an EXCiPACT Certificate and Audit report will go a long way in helping supplier approval and allow all parties to maximise benefits whilst minimising the risks.

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As an excipient user, our Company has a Corporate set of GMP requirements that internal supplier auditors use.  Would a resource from Excipact be willing to help compare Excipact GMP/GDP requirements with our Corporate GMP requirements?

EXCiPACT would not be able to perform this itself, however we know of some consultants who work with EXCiPACT who could provide this service.

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How is Excipact encouraging excipient suppliers to seek certification?

Through webinars like this, trade and other journal articles, and attendance at conferences. Also through our founding members’ links and memberships. We are also advocating that excipient users suggest it is a good idea to their suppliers! We are very happy to provide materials to help introduce the Scheme and its details to all who can help us to “spread the word”.

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Comment on Excipact vs Rx360?

EXCiPACT has an agreement with Rx-360 such that Rx-360 uses the EXCiPACT GMP standard in its audits of excipient manufacturers. Therefore, the assessments from either are to the same standard.

Otherwise, in short Rx-360 holds the audit report and distributes it after contracting a 3rd party audit organisation and auditor. In EXCiPACT the supplier holds the audit report and distributes it to its customers. This means less legal and confidentiality agreements all round with EXCiPACT. Auditors used by our appointed 3rd party Certifying Bodies must have successfully undertaken an EXCiPACT training course, exam and been successfully witnessed during their first audit before their competency is confirmed as a fully qualified EXCiPACT Auditor. This is not the case for Rx-360 auditors.

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For a multi-excipient supplier, can the audit be focused on one particular product? (rather than focused on general quality systems)

Certainly – you need to agree this with the Certifying Body at the start of the audit process.

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Thanks for the reply, I kind of see EXCiPACT as a baseline GMP, but the formal risk assessment for the excipient then comes based on the usual QRAs which are based on a product, rather than the excipient.

Yes, we see EXCiPACT as having broad applicability to a wide range of excipients, but there will be somewhere the risk assessment determines that more controls are needed. But even here we hope that any audit limits itself to those additional aspects that need to be assessed and the excipient user does not spend the time duplicating the basic Quality Management System elements like document control and complaints handling.

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Considering the huge constraint on the current number of auditors, what impact can this have on the efficiency of the audit? Aside of cost benefit and compliance, what other benefits is there for the pharmaceutical company?

The presentation indicates just how valuable it would be to the pharmaceutical company to save on audits of its suppliers. However, we feel the biggest additional benefit is having access to an annual audit report from the supplier. This frequency of information is far higher than most pharmaceutical audit cycles, which can be as long as once every 5 years. In this manner you can remain assured that GMP and GDP are being implemented effectively by your supplier leaving your own resource to focus on more pressing priorities.

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