R&D Pharma applies production methods, in line with EU Guidance, on GMP, and GDP (Good Distribution Practice), across its production facilities and suppler networks, following the EU Directive 2003/94/EC. Detailing requirements across the following areas, personnel, buildings and facilities, equipment, product containers, packaging, and more.
At R&D Pharma, we take every opportunity to apply these guidelines, as we feel it assures quality across our processes, and offers peace of mind, and confidence to our clients.
We ensure that all personnel involved in the production, of intermediates, and API’s, within both our facility, and supply chain, have attained the correct level of training, and qualification to necessitate the quality, and consistency of the produced products. We also audit both numbers, and quality of production staff, to ensure training, and adequate time exists within the production process, guaranteeing as far as possible, an efficient and effective process.
At R&D, we take great care to understand the requirements of a products manufacture within our supply chain and have established an environment which, when considered together with measures to protect the manufacture, presents minimal risk of causing contamination of materials or products. We have considered the aspects of maintenance, lighting, cleaning, temperature, humidity and ventilation and satisfied ourselves that they are satisfactory meeting guidelines. and do not adversely affect, directly or indirectly, either the medicinal products during their manufacture and storage.
Steps are taken to restrict access to unauthorised personnel, as well as the entry of foreign bodies such as insects or other animals. Using theses stringent and documented procedures, the risk of Cross-Contamination during the production process is negligible. On completion of the manufacturing process, the products are placed within a purpose-built storage area for either quarantine, testing, rejected or release, establishing defined storage is a key part of our quality procedures.
The production equipment used within our supply chain, is designed and maintained to not, present a hazard in its use and to suit its intended purpose. A rigorous, documented, cleaning routine exists for the equipment, which is detailed within a written procedure.
Product Containers & Packaging
Product containers used prior to packaging, are clinically sterile reducing to a minimum the opportunity for cross contamination of the product. The Packing area is separate to the production, but is still maintained to sterile standards, employing internal separated defined areas for different drug packaging. With suitable lighting, heating and ventilation to not effect the products stored.
This detail offers a brief overview of the steps taken by R&D Pharma, to produce and ensure the quality of Intermediates and API’s produced under our instruction, and whilst it is not an exhaustive description, a full in depth document is available upon request.