BIOPLUS LIFE SCIENCES PRIVATE LIMITED — MHRA GMP NCR Findings

The Inspection in December 2019 identified failures in the measures to prevent and detect cross-contamination and presented a risk that cross-contamination between products could occur and would not be detected the vendor approval process did not adequately consider the risk of contamination to existing products when introducing new raw materials; the integrity of reported data could not be relied upon; the site had contravened the restrictions on the 2014 GMP certificate. Action taken/proposed by the NCA: Recall of batches: Member states should contact the site to determine the level of risk associated with specific products released to market. MHRA would recommend determining the criticality of the products on the market and to assess if a precautionary recall is appropriate. Prohibition of supply: No batches to be supplied to EU markets whilst this statement of non-compliance remains in force. Additional Comments Additional comments : Withdrawal of previous GMP Certificate No: DK H 00111418 (and previous certificate DK H 00049315 and DK H 00011411). Issue of a statement of non-compliance. Due to the nature of the issues identified batches not released to market and included in the scope of the SNC.