Department of Health evidence to the House of Commons Health Select Committee inquiry into the shortage of generic medicines has revealed why the Medicines Control Agency suspended Regent Laboratories manufacturing licence at the end of last year (PJ, January 2, p7).
The Department's written submission says that there were "a number of critical failures and other major failures to comply with good manufacturing practice". These involved serious deficiencies in procedures for controlling process changes, auditing systems and releasing batches.
The critical failures referred to by the Department included major processes not being properly controlled or validated, a danger of penicillin contamination of products (evidenced by the detection of penicillin outside its designated work area) and the release of batches by selecting only those quality control results that complied with the specification, while ignoring others.
Because Regent was known to be one of the main generics manufacturers, the Department considered the availability of alternative products, the evidence says. This included taking advice from the British Generic Manufacturers Association, which had said that other manufacturers would make good the gap in the market.
The evidence made it clear that Regent intended to regain its manufacturing licence and that the MCA would act as quickly as possible once the company was ready. Regent and the MCA were in contact with each other and remedial plans and their timetable were being discussed so that inspection of the company could take place as quickly as possible. In the event of a successful inspection, the MCA expected to lift the licence suspension within a matter of days.
However, the Department warned that the lifting of the licence suspension could be full or partial and that the company would take some time to resume full production.
Mr Michael Billington (Regent's production manager) told The Journal on November 17 that the company had invested £2m in refurbishment over recent months and that all its quality manufacturing procedures had been thoroughly reviewed. Management had also been restructured.
"We are hopeful that the licence will be restored quickly and that production will be phased in over the next few months," Mr Billington concluded.