Purolite Romania achieves renewal of GMP certification.

February 5, 2019—Braşov Romania – The National Medicines Agency and Medical Devices in Romania has certified that Purolite S.R.L in Romania has passed inspection of its subsystems to enable the production of active substances and medicinal products and has issued a GMP certificate. Purolite has held this certification since 2009 and has used the certification as a continuous improvement tool over this time. The Certificate, Number 006/2019/RO, states that the facility conforms with the Good Manufacturing Practice requirements set forth in Article 111 (5) of Directive 2001/83 EC for the National Agency for Medicine and Medicinal Devices from Romania. The certificate was renewed on February 5, 2019 and will remain valid until 14 December 2021 and covers the Active Pharmaceutical Ingredients (APIs) that are produced at Purolite’s plant in Victoria, Romania. These products include Sodium Polystyrene Sulfonate and Calcium Polystyrene Sulfonate—used to control levels of Potassium in patients with Kidney disease—as well as Cholestyramine, which is used to control high cholesterol levels. 

This certificate and all supporting inspection reports are recognized worldwide. All manufacturers engaged in producing medicines for distribution in Europe must hold this certificate to ensure that products produced at the facility comply with GMP guidelines and are manufactured with patient safety as a priority. This certification is also necessary to facilitate import of these products into other countries.

The National Medicines Agency and Medical Devices in Romania will enter this information in the EudraGMDP database as well as share the information with the U.S. FDA.

Mark Price, Corporate QA and Regulatory Affairs Manager for Purolite notes, “The renewal of the GMP certificate is a testament to the continuing hard work and expertise exhibited at our Victoria site. It is an appropriate recognition of the continuous improvement promoted at the Romanian plant and the compliance activities undertaken by all staff every day to guarantee product safety and suitability. Congratulations to all involved!

A certificate for Good Manufacturing Practice (GMP) is designed to protect the consumer and ensure that each batch of medicine produced will meet quality standards promoting the products safety and efficacy. The certificate ensures that the manufacturer meets a minimum standard in their production process to make the product fit for human use. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonizing GMP activities at the European Union (EU) level. All manufacturers of medicines intended for the EU market—no matter where in the world the company is located—must comply with the GMP standard.

The GMP standard requires that medicines are high quality, are appropriate for their intended use and meet the requirements of the marketing authorization or clinical trial authorization. The standards are used to reduce risk and safeguard the health of consumers and patients. The system is not a prescribed instruction for manufacturing products, but a set of guidelines based on principles of hygiene, controlled environments and processes, training, record keeping, safety recalls, complaint tracing, recall systems and other measures.

The certification process involves a series of audits and inspections that review the quality system, and pre-requisites including employee cleanliness and training, document and record controls, building and facility design/maintenance, equipment calibration, production and process controls, data integrity, packaging and labeling, and warehousing, storage and distribution. Inspections do not involve a pre-prepared or routine checklist and may cover any factory system.

Congratulations to the team at Purolite S.R.L. for the successful audit and achieving maintenance of the certification.