UK health regulator withdraws Wockhardt unit certification
UKs health regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), has withdrawn good manufacturing practices (GMP) certification of Wockhardt Company’s Chikalthana facility in Maharashtra. According to a communication made by MHRA, the UK health agency has mentioned about its decision to withdraw the GMP certification that was earlier issued to Wockhardt’s said manufacturing unit in Aurangabad.
According to MHRA, a restricted GMP (good manufacturing practice) Certificate would be issued to the manufacturing site in addition to the statement of non-compliance for the given site. The impact of this restriction may not be precisely known at this stage, but will eventually be clear after further communication is received from MHRA.
With an aim to avoid shortage of essential medical products, the GMP certificate would be restricted and will continue with certain conditions that the company has to follow. The GMP certification would be for continuing the functions of critical products in the area of manufacturing and QC testing. This would be permitted in situations that have been agreed by the national competent authority or EMA. Thus, the company would continue to manufacture products that are critical to public health.