Regulatory Focus™ > News Articles > Agila Hit With Statement of GMP Non-Compliance From Polish Regulators

Agila Hit With Statement of GMP Non-Compliance From Polish Regulators

Posted 19 January 2016 | By Zachary Brennan 

Agila Hit With Statement of GMP Non-Compliance From Polish Regulators

Mylan subsidiary Agila Specialties has received a statement of good manufacturing practice (GMP) non-compliance from Poland’s Main Pharmaceutical Inspectorate at its Warsaw-based manufacturing site.

Polish regulators found 29 major deficiencies posing a risk of microbial and particulate contamination, most of which were linked to the design and qualification of air flow systems and clean areas, cleaning and maintenance, manufacturing and batch releases that do not comply with GMP requirements and change control.

Inspectors found “crumbling insulation of pipes, peeling Teflon on the ports of tanks and pumps, lack of labelling and mixed clean and dirty equipment, [and] chipped glass accessories.”

In addition, after the company’s HVAC (heating, ventilation and air conditioning) system of vials and prefilled syringes lines were “significantly modified,” in December 2014, 49 batches were manufactured through July 2015 but “without qualification after the change.”

However, Agila said it performed a quality risk assessment on its ampules and pre-filled syringes manufactured between 6 January 2015 and 23 September 2015 and found the risk of product defects was low.

“Quality Risk Report for each batches might be available to the NCAs [national competent authorities] where the products are marketed. Each involved NCA should evaluate, following assessment conducted in conjunction with MAHs [marketing authorization holders], if a recall of medicinal product is needed," the statement said.

The inspectorate also noted that since October 2015, manufacturing at the plant has ceased and not all corrective actions have been completed. On 9 December, Polish regulators decided to suspend manufacturing activities from the site until the removal of the non-compliance issues.

“Reinspection is planned in the near future - after removing non-compliances,” the regulator said.

This isn’t the first sign of trouble for Agila’s Warsaw site. Back in February 2014, Mylan recalled 10 lots of an Etomidate injection, bearing a Pfizer label, “due to the potential for small black particles, identified as paper shipper labels, to be present in individual vials; the potential for missing lot number and/or expiry date on the outer carton, and the potential for illegible/missing lot number and expiry on individual vials.” 


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