Raw material contamination a hot topic at AAPS
Speaking at an AAPS Hot Topic seminar, Richard Moreton, vice president of pharmaceutical science at FinnBrit Consulting, highlighted the level of change that will be needed in the coming years.
Moreton demonstrated the current state of affairs by asking if any of the R&D workers and clinical trial suppliers in the audience knew the source of every ingredient they used; very few, if any, hands were raised.
To minimise the risk of a repeat of the glycerin and heparin scandals Moreton called on companies and regulators to initiate changes in policy and attitude. Glycerin contaminated with diethylene glycol has killed around 600 people over the last 70 years.
Relating to raw materials across the board Moreton said that non-specific assays need revising as they make it easier for fraudsters. Before changes to assays are implemented Moreton said that companies should be aware of their particular limitations, which is especially important for excipients.
In addition to changes to particular technologies Moreton said that education and attitudes to raw materials need to change. There has been a trend towards this with three bills currently in the US Congress, which would impact on the excipient and active pharmaceutical ingredient (API) supply chain.
Moreton also mentioned the Food, Conservation and Energy Act 2008, which if applied literally would require any plant derived material used as an excipient to have its botanical source listed on the label.
If applied to the pharmaceutical industry Moreton believes it would be a “nightmare” but went on to say that regulations far more inconvenient than those currently in place could be applied in the future.
One such hypothetical regulation Moreton referred to was the adoption of glycerin-style quality controls for other products; a move he said would be costly but remained a possibility.
He added that any regulation must be globally applicable and highlighted material pedigrees as a system that has to be implemented; even suggesting it could be adapted to cover APIs.
Immediate actions
With changes to regulations possible in the foreseeable future Moreton said that companies need to be preparing for this while being proactive about improving their own checks and balances.
He believes that all suppliers will need to be fully audited to ensure quality, with paper audits being regarded as little more than questionnaires by Moreton.
The logistics of achieving this pose companies some difficulties, with Moreton saying that if a facility can be audited 50 times a year and has 200 customers, creative solutions will be needed to implement two or three year audit cycles. One way to resolve this problem would be to undertake group or third-party audits.
While preparing for new regulations Moreton also said companies should be initiating their own actions, reminding the audience that the product license holder has ultimate responsibility for the safety of the drug.
Consequently he recommended that companies get to closely know their suppliers and the supply chain, including details such as whether the product was shipped in a dedicated container and whether it went by air, rail or sea. These factors all raise different contamination threats, as do a products transfer points and packaging, and companies should be aware of these risks.
