Third party audits - meaning

External third-party audits include an outside party to examine the system. This can be a contractor, a regulatory agency, or a customer. A third-party audit typically means an outside consultant or organization comes in to look at your system and compare it with standards or regulations from yet another standpoint. 

The Regulations provide a range of means for assessing conformity. However, as far as electrical equipment is concerned, conformity assessment through a notified body will be the norm, following much the same EC type examination processes and procedures that have been used in the past. There are, however, additional requirements for product quality control and third party audits. In the UK, the Electrical Equipment Certification Service (EECS) and SIRA Test and Certification Ltd already provide conformity assessment services, basing their assessments on the harmonised standards that already exist for explosion-protected electrical equipment the main standards are identified in Chapter 15. 

For any new excipients, APIs or drug products (where new does not necessarily mean novel, but new to the receiving site) there are additional testing criteria, e.g. supplier audits, third-party contract laboratory audits, analytical method transfers, sample management/tracking, etc. For those key excipients, where there is on-site historical experience, it still behoves both parties to check whether the local grade/supplier used by the CMO is equivalent to that used by the supplier (Worsham, 2010). There are many examples of differences in excipient physical properties, e.g. particle size, which have been attributed to different excipient sources that could ultimately impact on the performance of those excipients in formulated products (Frattini and Simioni, 1984 Dansereau and Peck, 1987 Phadke et al., 1994 Lin and Peck, 1994). 

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