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Challenging: audits of suppliers in Asia.
Challenging: audits of suppliers in Asia.

Active substances are increasingly being sourced in Asia. This poses logistical and financial challenges to pharma-ceutical companies when qualifying suppliers.

Supplier qualification procedures and audits are integral parts of the quality management systems of regulated companies. For pharmaceutical companies, the directives of the EU GMP guideline implemented in national law (e.g. section 11 of the German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV) require regular reviews of the suppliers. The interval between these reviews depends on the company's own risk assessment - the usual length is two to three years. Thus, the audit requirements rise in proportion to the number of suppliers. India and China have become very important in this regard and they require time-consuming and travel-intensive «Asian audits».

Chemgineering is a specialist for third-party audits and can help to reduce the costs of qualifying suppliers significantly. The «shared audit partnership» model is based on cost-sharing. The combination of audits in «shared trips» and «shared audits» significantly reduces the relative travel times and costs.

As an independent service provider, Chemgineering has the advantage of having a large pool of customers, which considerably increases the options for sharing. In 2014, there was a clear rise in the number of audits, which we attribute to the increased attention paid by the authorities to audits and audit reports. In 2015 we conducted more than 20 Asian audits and thus once again expanded our shared audit portfolio. The auditee and product lists of our participating companies are regularly reviewed for matches between suppliers and products. Our calculation method calculates the cost savings we pass on to our clients. The synergies result from the number of parties interested in an audit and the audits on a «shared trip».

 

Challenges in implementation
Based on a general contract, at the end of each year our participating customers send us a list of the auditees for the following year. The challenge of the shared system is to plan the most efficient audit trips possible. The auditees must be classified geographically and travel routes specified, taking into account the urgency of the audit. Corresponding visa requirements must be met in a timely manner – our auditors generally have one-year multiple-entry visas. The auditees can help with travel planning, as they are familiar with the locations, although Chemgineering has developed a profound knowledge of the local situations over the years and can do everything independently as well. A well-prepared shared-audit trip makes ad hoc on-site organization superfluous, so that the auditor can focus entirely on the audits. Asian audits generally demand a lot of the traveler due to the changing climates and time zones. If the client has no contact data available for the auditee, Chemgineering has a database of earlier audits and contacts available. Differences in the time zones and communication in English that is sometimes hard to understand also make audit planning more difficult. Finally, the audit date is communicated to the clients and the phase of collecting information begins. For preparatory purposes, the auditee is given a Chemgineering questionnaire. At the same time, basic information is procured from the client, including product data, site master files, lists of recalls and earlier audit reports.

Cultural differences also increase the complexity in conducting Asian audits. For example, in China documentation is done primarily in Chinese, so that only figures are recognizable. This necessitates special interviewing and fact-gathering techniques. In India, a knowledge of hierarchical and caste systems is essential. Experience with Asian audits is an advantage and can be crucial to success in the form of an informative and reliable report as the basis for assessment.

When the audit has been conducted on site, the auditor immediately provides a summary statement to the customer and begins preparing the audit report. Audit reports are finalized within 30 working days and sent to our clients in PDF format, on CD and as a signed hardcopy; the list of deviations is sent to the auditee in parallel. Chemgineering generally tracks the remediation of shortcomings (CAPAs). The auditee is given a period of 30 working days to initiate corrective measures (10 working days for critical defects). The proposed measures are assessed by the auditor. Thus, the audit can be completed for our clients without effort on their part and the required audits are successfully processed cost-effectively at the end of the year.

 

Our expertise
Chemgineering employs auditors with more than a decade of experience in regulated industry and has many years of experience in third-party audits. The continuous ongoing advanced qualification of our auditors as well as the continuous conduction of audits and other hands-on compliance projects ensure the professional and intercultural competence of our auditors.

 

Mohamad El Zein|Management Desk Officer & Audit Coordinator|Chemgineering|The Business Designers

 

 

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