According to reports posted on the EudrGMP database, inspectors who visited the sites in Hunt Valley and Cockeysville in Maryland in February uncovered a number of compliance problems, several of which were classed as critical.
At both sites the Medicines and Healthcare Products Regulatory Agency (MHRA) team reported a "failure of organisational and technical measures to minimise the risk cross-contamination between hazardous and non-hazardous products manufactured in the same manufacturing facilities using shared equipment
At the Hunt Valley site the inspectors observed "a gross failure of change management" that included the use of an unqualified HPLC system and an "unacceptable approach to production equipment qualification."
They also reported that quality investigations also lacked implementation of quality risk management principles.
Similarly at the Cockeysville facility the MHRA inspectors identified data governance failures relating to the generation and checking of analytical data from electronic systems. They also reported inadequate investigation of data integrity failures, deficiencies in sterilisation and depyrogenation processes and insufficient control of aseptic operations.
The UK regulatory agency withdrew the Hunt Valley site’s good manufacturing practice (GMP) certificate - UK GMP 22917 Insp GMP 22917/37149-0006 - which was issued in 2013.
It also recommended that products made at the facility – Ammonaps and Lutigest - should be recalled “where market alternatives and medical criticality permits."
The agency said PII should amend a proposal to make clinical trial supplies at the facility for an unidentified clinical study and conduct a risk assessment to determine the risk posed to trial subjects.
The MHRA also recommended that products made at the Cockeysville site should be recalled “where market alternatives and medical criticality permits."
Julien A. Hecht, Vice President and General Counsel Pharmaceutics International, Inc. (Pii), told us "since the time of the MHRA inspections, Pii has been working continuously to remediate all of the agency’s observations and comments. Beginning in April, 2016, after conducting a thorough search and interview process, Pii brought in a team of experts, each with specialized expertise, to address each of the agency’s substantive areas of concern.
"These remediation efforts have the highest priority at Pii and significant resources, in terms of both dollars and personnel, have and will be expended as part of this process. Pii, which has always been dedicated to supplying safe and effectives products to its customers and patients, is committed to seeing this process through to its conclusion, and remains confident that it will be able to rectify the issues and provide the quality management required by the MHRA."