SUPPLIER AND SUBCONTRACTOR AUDITS SHARED AUDIT SERVICES
Rapid implementation and optimisation of your audit schedule, providing a ‘win-win’ solution SHARED AUDIT SERVICES
Our shared audit expertise can be applied to these audit situations • Raw materials suppliers • Packaging materials suppliers • Subcontractors including manufacturing, analytical laboratories, packaging, transportation and distribution ... and many more.
Our Shared Audit Services and You
Comprehensive supplier and subcontractor audits are a priority for you. All regulatory agencies who set standards for the pharmaceutical industry have an expectation of GMP compliance across pharmaceutical manufacturing supply chains. As a consequence, pharmaceutical companies have an obligation to engage with their supply chain members to ensure compliance through robust auditing of their supply chain. Your suppliers and subcontractors will on all stakeholders by combining requests to • Rapid implementation of the audit that is experience repeated demands by their audit a particular supplier site. This directly geared to your schedule customers to host audits of their operations translates into reduced audit costs. • Greater collaboration and easier access which are both costly and time consuming. A Our auditors can demonstrate their to the audit sites through reducing shared audit approach can help you to avoid competence, training, skills and knowledge of the demands on your suppliers or the challenges of longer timelines to confirm the processes being audited and the laws and subcontractors an audit date, difficulties in organising joint guidance covering the audited operation. • Cost optimisation of your audit schedule. visits or even a refusal to be audited. Shared audits are conducted in accordance For the same cost, a larger number of These situations can be difficult to manage with relevant international standards such audits can be carried out compared with and pose both economic and regulatory risks to as cGMP, GDP, GLP, GVP & GCP, ISO 22716, an internal and individual process your business with the biggest risk concerned ISO 13485, ISO 15378, PS 9000, IPEC, EFfCI • Specialist auditors who are experts with achieving Good Manufacturing Practice standards and are specific to the type of audit in GxP and can demonstrate their (GMP) compliant audits that are conducted activity required in the context of the country competence, skills and knowledge within the necessary timelines. in question. • Audits that are conducted in the The shared audit approach guarantees every Our Shared Audits expertise language of the audited party instructing party a high level of satisfaction, Intertek’s shared audits services facilitate • Robust implementation and contractual bringing such benefits as: greater collaboration between your suppliers relationships in accordance with the and subcontractors by making audit requirements of the relevant standards scheduling easier whilst reducing demands
2 SHARED AUDIT SERVICES
1 Statement of requirements within the Shared Audit System
Shared Audits, the Intertek Way
5 2 • A simple, effective and secure management tool • Experienced auditors with highly relevant knowledge Issue of a report specific of relevant international Optimisation of audit to each instructing party standards programme
Choice of auditor Carrying out and audit planning the audit 4 3
Personalised audit reporting • Real time view of planned audits and audits With over 10 years’ experience over 5 You will receive the exact information to meet undergoing planning, continents, our auditors have won the your auditing requirements via a personalised • Permanent access to an audit as a new continuing trust of more than 500 clients. audit report whilst benefitting from the cost instructing party Bringing quality and safety to life, our efficiencies of the shared audit process. Added team of over 100 specialist auditors are • Data is held in confidence via secure Web optional benefits include evaluation of the deployed across all areas of production and access supplier’s action plan from the auditor, on-site distribution for raw materials, healthcare monitoring of the action plan implementation • A choice between managing programs and a and beauty products. Our auditors’ and technical support during the audit. one-off audit knowledge helps you to identify and • Access to the experience and qualifications of mitigate the intrinsic risk in your operations, Intertek’s online platform Intertek auditors, supply chains and business processes. Intertek’s confidential shared audit online • A contractual relationship in accordance with The pharmaceutical industry faces great platform allows secure and confidential access the requirements of the relevant standards, challenges from increases in health to a real-time view of forthcoming scheduled • Individually tailored audit programs that authority inspections, increasingly complex supplier shared audits, including those proposed incorporate the specific expectations of each globalised supply networks, to ever and those already in progress. instructing party expanding regulatory expectations. After logging into your secure account you • Verification of Intertek’s independence relative We can help our customers to overcome can also view details of past audits for to the audited entity these challenges through our Total Quality specific plants and view requests for audits. Assurance expertise for shared audit The online platform allows a simple means services, delivering consistently, with to apply to participate in a shared audit and precision, pace and passion, enabling our initiate and manage your supplier audits with customers to power ahead safely. the benefits of the following:
3 Europe +33 (0)4 37 49 73 81 UK +44 1763 261 648 Asia +86 (21) 6073-7736 USA +1 (908) 534 4445 x669 [email protected] intertek.com/pharmaceutical/auditing