MHRA Delays Nordic Pharma’s Attempt to Add New Indian CMO Site to Marketing Authorization
Posted 10 June 2016 | By
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Friday announced that it has put on hold the addition of Indian contract manufacturing organization (CMO) Akums Drugs' Haridwar-based site as a manufacturing facility for the marketing authorization of Nordic Pharma's hormone injection progesterone due to a lack of sterility assurance.
An MHRA inspection of the site (its first inspection for the site) on 13 April revealed one critical and three major deficiencies.
“The critical deficiency was for lack of sterility assurance, as there was insufficient evidence during validation to confirm that all ampoules in the load met the sterilising conditions of 160oC for 2 hours, a weak sterility sampling plan and lack of qualification of the leak test cycle, MHRA said.
The major deficiencies were for inadequate control and validation of sterilisation, deficiencies across all aspects of the quality management system and lack of a robust environmental monitoring programme. 13 other deficiencies covering all aspects of GMP were recorded but not formally reported so as not to distract from the critical and major deficiencies.
The UK regulator noted that the site currently manufactures some unlicensed progesterone injections supplied to the UK and Ireland, and four batches will be recalled, although there is little stock expected on the market.
A notification to healthcare practitioners has been issued, MHRA said, noting that additional monitoring should be considered. Neither Nordic Pharma nor Akums responded to requests for comment.