Ricesteele and GMP

Good Manufacturing Practice or GMP is ‘that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use’. Ricesteele Manufacturing Ltd is licenced by the Irish Medicines Board (IMB) and adheres to the standards of GMP.

Why GMP?

The Principles and Guidelines for GMP for medicines for human use are stated in Directive 2003/94/EC. These regulations which have the force of law require that manufacturers, processors, and packagers of drugs, medical devices, some food and blood products take proactive steps to assure their products are safe, pure and effective.

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups and errors, this in turn protects the customer from purchasing a product that is not effective or even dangerous.

Who Audits Ricesteele & Why?

The IMB is the Competent Authority in Ireland for the implementation of EU and National legislation relating to medicinal products for human use. Under European and Irish legislation, before a medicinal product can be authorised for use, an application must be made to the IMB and this must contain all of the necessary data supporting its quality, safety and efficacy.
Following approval of a medicine for use and the issue of its product authorisation, the IMB monitors the quality of medicines by conducting inspections at sites of manufacture and distribution and also by random sampling of products both pre and post authorisation.
Ricesteele is inspected for Compliance with GMP on a biennial basis by the IMB, who then issue a ‘Certificate of GMP Compliance of a Manufacturer’ on the satisfactory outcome of an inspection. This certificate of GMP Compliance then permits Ricesteele to manufacture medicinal products. The Manufacturing Authorisation number held by Ricesteele Manufacturing Ltd. is M95 as issued by the IMB.

IMB

The mission of the IMB is ’to protect and enhance public health and animal health through the regulation of medicines, medical devices and healthcare products’.
The IMB together with the assistance of the Board’s committees and individual experts review the scientific aspects of each application and reach a conclusion of the likely balance of any benefits versus risk of the product. Post approval of a medicine, the IMB monitors the type and frequency of reported side-efffects and quality defects. Licence holders are also responsible for keeping the IMB informed of events with potential safety consequences for their products.
For more information on the IMB please visit their website here.