Members of the Audit Standards Working Group met in Philadelphia on 25th and 26th February. The team consists of a large number of people from the supply base and pharmaceutical industry. Due to adverse weather conditions in the USA not everyone was able to travel to Philadelphia, so we had a combination of face to face and teleconferences. Despite these practical difficulties the team made excellent progress.
The work of the Audit Standards Working Group is split into several sub-groups, as there are a wide variety of standards which are required. The Audit Standards Working Group and its sub-groups consist of 27 participants from 19 different companies and organizations. There are 6 sub-groups: APIs, Excipients, Supply Chain Security, Basic Chemicals, Packaging and Print. Of these sub-groups the first four are active and standards are being finalised. Wherever possible we are adopting existing standards and are working closely with other organisations. For example, PQG/IPEC are in the process of updating the excipients standards.
The standards will be used in a pilot to prove the whole auditing process. The current thinking is that a minimum of 3 standards will be used within the pilot programme.
These are likely to be: API, Excipients and Basic Chemicals, in conjunction with the Supply Chain Security checklist, which is to be used alongside all of the other standards.
If you would like more detailed information about the work of the Standards Working group please contact Lee Nagao in the DBR secretariat, who supports the Audit Working Group.