Quality Control Support for BB-NCIPD , Bulgaria

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WHO was informed of a quality complaint concerning lot no. D2076 of Td (tetanus-adult diphtheria vaccine) produced at BB-NCIPD, Ltd, Sofia, Bulgaria and distributed by Intervax. The complaint related to the presence of a foreign object (metal nut) in a vial of the batch supplied to Peru through the Revolving Fund of the Pan American Health Organization. No other complaints regarding this lot, other lots of Td, or other vaccines produced at the facility have been received. PCS has helped BB-NCIPD resolve this issue and once again supply vaccines through the following services; Review of answers related to audit-findings by agencies including WHO. Review against current Good Manufacturing Practices of defined Quality Management System Elements as sentd by BB-NCIPD. Provision of on- and off-site advice relating to GMP, quality assurance and regulatory aspects associated with Quality Systems of BB-NCIPD.

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