Our first pharmaceutical lead auditor course ran in the Royal Plaza Hotel in Hong Kong on 20-24 Jun 2011 received a warm welcome from the delegates. The venue was the five star hotel in Kowloon. Our partner is Hong Kong Veritas, a leading training and certification company. The level of the delegates was very high and included some regional quality directors for major pharmaceutical companies and the head of a local medicines inspectorate. The PS 9000 series were a pleasant surprise to them.
It would appear that with the right marketing these standards would have a bright future here. There is certainly a need for them and well trained auditors as witnessed by the regular press reporting of contaminated products, fraudulent adulteration and patient deaths. The penalties for the perpetrators can be draconian but there is no substitute for preventive action in the supply chain which auditing to these standards can provide.
Some good news
The Chartered Quality Insitiute (CQI) have introduced a new grade of membership – CQI Practitioner. The good news is that you can get this with the certificate of successful completion from our lead auditor course. There is no time limit so regardless of when you did the course you can apply.
The following is what we have received. More information is available on www.cqi.org
New Practitioners demonstrate acquisition of knowledge in at least one aspect of quality.
Alternatively, you may demonstrate learning through other qualifications and training, including evidenced on-the-job learning, of at least 30 hours study time.
New Practitioners demonstrate that they have a minimum of two years' work experience through submission of a CV, and that they have successfully applied their knowledge in a work context through submission of a completed Practitioner Portfolio Form.
With changing legislation, an expected high demand for second party audits and insufficient trained auditor, Excipact was the logical answer.
Excipact is a certification scheme for excipient suppliers by a group comprising the Pharmaceutical Quality Group (PQG), the FECC (European Association of Chemical Distributors), EFCG (Euopean fine Chemicals Group), International Pharmaceutical Excipients Council (Americas) and IPEC Europe.
The legislation on both sides of the Atlantic is being stiffened up to require all Marketing Authorisation holders to qualify their excipient suppliers
The EU requirements in the revision to EU Chapter 5 (5.26) states….The selection, including qualification and approval of suppliers….is an important operation which should involve staff who have a particular and thorough knowledge of the suppliers and the associated risks involved in that starting material’s supply chain certain excipients considered to be high risk materials used as starting materials, should be periodically audited to confirm that they comply with current GMP requirements and that supply chain traceability of the starting material is being maintained.
The findings from each audit should be documented, and audit reports should be available for review by Inspectors.
The risks on which the assessment will be based are expected to be similar to those in PS 9100 – excipient function, administration route, toxicity and potential inherent risk to the patient - but also to include past experience with the supplier, the source of the material and the supply chain including distribution.
With excipient suppliers expecting a tsunami of audit requests, insufficient trained auditors in the field and the potential for this to dilute resources from higher risk issues, the solution was a certification scheme acceptable to the industry and regulators. The authorities on both sides of the Atlantic have so far indicated that the use of properly trained and administered third party audits is acceptable.
The second draft of Excipat has been issued and comments are currently being reviewed with incorporation expected soon. Excipact is being registered as a legal entity, not for profit organisation.We are currently discussing auditor training with the Excipact executives and will be updating our courses in Europe, the Far East and Europe.
Excipact – a case for excipient audits