The Spanish Agency of medicines and medical devices (AEMPS) outlined its concerns in a post on EudraGDMP, explaining that inspectors who visited in June found that problems detected during an inspection conducted in 2015 have still not been resolved.
“The CAPA [corrective action and preventive action plan] for the previous EDQM inspection report were found as not having been implemented in a satisfactory way.”
Nitrofurantoin is an oral antibiotic that is used to treat bladder infections.
It has been available since 1953 and is listed on the WHO’s essential medicines list.
AEMPS added that: “Critical deficiencies were found on raw data safety, control and OOS review. Moreover, several major deficiencies were found in training, change control, quality assessment, process and cleaning validations.”
The 2015 inspection was conducted by a team from the Italian Medicines Agency (IMA) as part of an EDQM programme. They identified 18 deficiencies, one of which was classified as critical and six as major.
According to their report the critical observation related to an unofficial and non-controlled storage area which "had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall, which during the inspection the Company was requested to remove.
"The material stored in this area was to be managed outside of the Quality Assurance system and the investigation carried out by the inspection team concluded there was a serious risk of data falsification."
"One of the six major deficiencies was related to a very similar issue, as access to a locked garage was given to the inspection team only hours after requesting it. In both cases the explanations provided were not sound and different versions were given during the inspection."
Other problems identified by the Italian team related to QA training, cleaning validation, data integrity and the "qualification of contract manufacturer of a key intermediate of Nitrofurantoin production."
Jinan was stripped of its Certificate of Suitability (CEP) for the antibiotic active pharmaceutical ingredient (API) nitrofurantoin after the inspection last year.
A few months later Jinan contracted US generic API firm ChemWerth to help it address the good manufacturing practice (GMP) deficiencies.
At the time Cheng Yushui, general manager of Jinan Jinda, said the firm had signed “a five year service agreement with ChemWerth with the goal being to correct Jinda’s quality system and GMP compliance conditions.
“With ChemWerth’s help, we plan to reapply for EDQM re-inspection within one year. Our commitment to be a qualified supplier for the EU and US regulatory markets has never changed.”
During intervening period Jinan continued to supply nitrofurantoin – which is listed on the World Health Organisation’s (WHO) essential medicines list – to manufacturers in the European Union according to AEMPS.
The Spanish regulator said that, as a result of the latest inspection, Jinan should be prohibited from supplying the API.
Neither Jinan nor Chemwerth responded to a request for comment ahead of publication.
A Chemwerth spokesman told us "Since the June 2015 EDQM inspection which resulted in suspension of Jinda's CEP, Chemwerth has worked alongside Jinda to remediate the GMP issues found during this EDQM inspection.
He added that: "Chemwerth and Jinda both feel that Jinda has made significant progress on addressing these issues. The focus of any agency inspection should be to determine if the safety and quality of API supplied by the firm meets the highest standards. Chemwerth and Jinda both feel that their products meet this criteria."