Pharmaceutical Shared Audits
Pharmaceutical shared audits that provide a cost effective solution for evaluation of suppliers and subcontractors in the pharmaceutical or cosmetics supply chains plus purchase of existing audit reports
Pharmaceutical shared audits bring cost efficiencies, make audit scheduling easy and help to facilitate greater collaboration with your suppliers.
There is an obligation to engage with supply chain members on matters concerning quality. However your suppliers and subcontractors are increasingly being asked to take part in audits, all of which demand precious time and resources. With such a demand, it is important to avoid situations where deterioration of relationships with supply chain members lead to longer timeframes for confirmation of audit dates or where there may be a reluctance to allow auditing to start.
Pharmaceutical shared audits can reduce demands on time and resources for all stakeholders in the supply chain by combining the requests to audit a particular supplier site. This in turn can help to optimise your budget through reduced audit costs.
Our shared audit team are a global network of highly trained professionals who have both local knowledge and an in-depth understanding of the relevant national and international regulations. Audits are conducted in the language of the organisation being audited.
Our confidential shared audit system allows access to a real-time view of Intertek’s forthcoming scheduled shared audits: those proposed and those already in progress. After logging into your secure account you can view details of past audits for specific plants, view requests for audits and also apply to participate in a shared audit. The shared audit system allows a simple means to initiate and manage your required supplier audits.
Our shared audits are conducted in accordance with relevant international standards and are specific to the type of audit activity required. Our shared audit teams carry out audits with reference to cGMP, GDP, GLP & GCP, ISO 22716, ISO 13485, IPEC, EFfCI standards within a European, North American, Japanese or Australian context.
Benefits of our Shared Audits services
Our pharmaceutical shared audits simplify the process of audit scheduling and help to facilitate greater collaboration with your suppliers and expedite access to the audit site. You will receive the exact information to meet your auditing requirements via a personalised audit report whilst benefitting from the cost efficiencies of the shared audit process. Added benefits include evaluation of the supplier’s action plan from the auditor, on-site monitoring of the action plan implementation and technical support during the audit.
Tailored Shared Audit Applications
We apply our shared audit expertise to the following:
- Suppliers, APIs, excipients, cosmetic ingredients, starting materials, packaging materials and more.
- Contract Manufacturing Organizations, Pharmaceutical, Cosmetic, Medical Devices and Nutritional Supplements.
- Contract Research Organizations: Clinical Research Organisations, Contract fill and finish and more.
In some cases, we are able to offer the purchase of an existing GMP, GDP or GCP audit report. This a confidential process which enables us to explore, on your behalf, the potential purchase of an existing audit report. This represents cost-savings to both audit report owner and enquirer. This offer was established to help clients with the growing demand for information about suppliers and in particular, greater detail about specific sites. It is also a useful alternative to consider if a physical audit is difficult to schedule. Please note that this process can take several weeks and may be inconclusive if a report owner stakeholder decides not to proceed with allowing the purchase.
With over 500 global clients who put their trust in us to meet their auditing requirements, our shared audit system and services provide cost-effective and responsive auditing solutions for the global pharmaceutical and healthcare industries. With 30 years’ international experience in auditing and evaluating production and distribution sites, Intertek offers you a truly tailored and unique service that will meet your specific needs. Our Total Quality Assurance expertise enables you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.