IPEC Federation Published
Position Paper on Third Party Audit and Certification Programmes

Problem statement:

Pharmaceutical manufacturers are facing increased regulatorydemands to ensure that the raw materials used in their medicines - includingexcipients - are safe, of high-quality, and sourced from reputable supplierswho adopt appropriate good practices. In turn, excipient suppliers are facingescalating numbers of site audits and related information requests to ensuretheir facilities and products meet the expectations of regulators. The auditburden on both parties is becoming insupportable, with many suppliers decliningaudits or only agreeing to host audits on a commercial basis.

Background/ Definitions

Credible third party certification involves both an independent assessmentdeclaring that specified requirements pertaining to a product, person, processor management system have been met and also that the certifying body hasindependent oversight to ensure impartiality and freedom from conflicts ofinterest. It is more robust than both first-party certification, in which anindividual or organization providing goods or services offers assurance that itmeets certain claims, and second-party certification, in which association towhich the individual or organization belongs provides the assurance.

There is an analogous situation regarding audits, that is:

·        1st party - the supplier audits itself

·        2nd party - the customer performs the audit or contracts someone toaudit on their behalf

·        3rd party audits - A party who is independent of both the supplierand customer performs the audit - this category includes regulatory audits /inspections.

The degree of impartiality of audits increases as follows: 1st <2nd < 3rd.

Position:

The IPEC Federationbelieves that independent, third party auditing and certification of excipientsuppliers can assist in the development, manufacture and supply of safe andeffective medicinal products. 

The use of thirdparty audit and certification programmes helps to reduce costs, time andresources of both excipient suppliers and users. Such third party auditand certification schemes both raise quality expectations to an industry-acceptedlevel and enhance patient safety.

The keyprinciples of third party auditing and certification as supported by the IPECFederation are:

-Excipient siteaudits are conducted by trained and qualified auditors. The third party providerensures that its auditors are competent with demonstrated knowledge andproficiency in excipient GMP auditing, prepare thorough audit reports, andunderstand the audit expectations of the referenced GMP standard.

-Excipient audit reports undergo a quality review to ensure clarity, completeness, and in thecase of certification, appropriate rating of observation severity.

-Excipient certification audit reports are assessed by qualified individuals with the authority todetermine if the site meets the requirements for excipient GMP compliance.

-Third party certification programmes are assessed for compliance to an internationalstandard such as ISO 17021 or 17065 by a recognized authority.

-Third party audit programmes meet the principles of ISO 17021 or ISO 17065 to demonstrate theabsence of conflicts of interest and be based on on-site audits that arecarried out by qualified, competent organisations.

-Certified sites are periodically re-audited by the third party to ensure continuing compliance toexcipient GMP.

-For schemes such as the 'Pharmaceutical Excipient GMP Audit Sharing System' in Japan where auditsare contracted out to the independent GMP Auditing Board for PharmaceuticalExcipients (GAB), audit outcomes are shared amongst its members.

The keybenefits of third party auditing and certification supported by the IPEC Federation include:

-Reduced auditburden for excipient suppliers when a third party audit addresses the need ofmultiple excipient users. Where the excipient supplier is certified, a copy ofthe excipient GMP certificate and audit report may suffice to meet the needs ofthe user as part of its supplier qualification programme.

-Reduced audit burden for users. Where a third party supplier audit is available, the user maythen shift audit resources to other suppliers. Third party certificationinvolves enhanced audit duration to more fully assess GMP compliance.

-Conducting of audits referencing Good Manufacturing Practice (GMP) and Good Distribution Practice(GDP) standards, such as the consensus developed NSF/IPEC/ANSI 363-2014 USNational Standard1 and the equivalent EXCiPACT™ standards assures industryacceptance Audit reports and Certifications are generated that are compatiblewith regulatory initiatives, including but not limited to

·        the Falsified Medicines Directive (FMD)

·        EU Part 1 GMP Chapter 5 Production (Most recent version)

·        The FDA Safety and Innovation Act of 2012 (FDASIA), which wasupdated to include "managing the risk of and establishing the safety of rawmaterials, materials used in the manufacturing of drugs, and finished drugproduct."

Rationale:

Regulatory authorities expect more objective evidence that the excipient supplier has implementedand complies with the principles of GMP in the manufacture of excipients andGDP for distribution of excipients. Increasingly the expectation is thaton-site audits are carried out, though the authorities do not mandate thataudits must be conducted by the 2nd party.

Properly executed third party audit and certification programmes which meet the IPEC Federation'sposition and expectations deliver benefits to excipient suppliers and users -as well as regulators - by reducing audit burden without any compromise inpatient safety.

Read the full position paper by clicking here