GMP failures at an aseptic plant owned by SCM Pharma are part of a wider industry trend affecting several sterile sites in the UK, according to the ex-owner of the CDMO.
Our sister publication Outsourcing-Pharma.com today reported Northumberland, UK-based SCM Pharma entered administration after Shire exercised a clause in its contract taking control of the contract development and manufacturing organisation (CDMO) in order to ensure supply of its short-acting sedative drug Buccolam (midazolam hydrochloride).
SCM’s problems stemmed from an inspection by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in March which identified a number of GMP violations at the firm’s Prudhoe plant, including product cross contamination, potential microbial contamination, and issues with the maintenance of equipment and facilities.
Fiona Cruickshank, who was the owner and non-executive Chair at SCM until stepping down last month, said despite working to fix the problems, the company “did not have the funds to operate with limited manufacturing and also invest in the agreed remedial work required to address the issues raised.”
However, she added the outcome of the audit “formed part of a wider industry trend this year that has seen several sterile pharmaceutical manufacturing sites in the UK also fail to fully meet the MHRA’s criteria.”
UK aseptic manufacture
When contacted by in-Pharmatechnologist.com, the MHRA said “there has been no change in the standards applied to the inspections of aseptic manufacturing facilities” but was unable to give details of any inspection reports referring to ongoing compliance activities.
According to the EudraGMDP database – a non-exhaustive list of European regulated non-compliance reports – only one aseptic UK facility other than SCM’s has not complied with GMP in the past year, that of ophthalmic manufacturer Moorfields Pharmaceuticals in London.
Elsewhere, another UK CMO, SCM’s Northumberland neighbour Aesica, has also recently halted “the manufacture of aseptic and terminally sterilised products” at its Nottingham site, according to company quality director Indira Walker.
Walker told us the decision to halt production followed an internal review at the start of the year in “parallel with discussions with the MHRA”
Last October, Aesica ‘injected’ £500,000 ($680,000) into its pre-filled syringe capabilities at the site as part of what the firm said at the time was an acceleration of “its credibility in the aseptic market.”
The Nottingham plant was set to come on line this year and produce batches of 5,000 syringes.