• Specialized in providing regulatory compliance with GMP requirements in critical manufacturing processes, the service offers a fully comprehensive assistance encompassing the whole life cycle of the drug product
  • The new Annex 1 sets the new standards of good manufacturing practices on sterile medicines production

Telstar has reinforced a GMP Pharma Consultancy Service specialized in assessment, diagnostic and implementation of comprehensive solutions for sterile processes and critical installations to operate in accordance with the last version of the EU GMP Annex 1 designed to comply with the maximum level of assurance in sterile production.

this specialized service is focused on helping pharmaceutical laboratories with sterile production to drive strategies and technologies integration with the goal of assuring the sterility of the finished products in accordance with the requirements of the new Annex 1 of the EU GMP on the manufacture of sterile medicines. The new version of Annex 1 sets the new standards of good manufacturing practices on sterile medicines production.

Although the new Annex 1 is currently under formal revision, it is planned that the new regulatory requirements will be enacted throughout next months. The scope of the changes contained in the new regulation lies in preserving the  safety in the whole manufacturing process while avoiding the presence of personnel as much as possible in areas where the product is exposed, as well as applying in depth a philosophy of risk analysis and updating to new existing technology, using the principles of Quality Risk Management (QRM) and implementing a Contamination Control Strategy across the facility. The new guidance requires companies to formally document a contamination control strategy which considers all the technical and organisational measures in place to ensure sterile products meet their critical quality attributes.

Aimed at pharmaceutical laboratories, Telstar offers a complete service to meet the requirements of the new version of Annex 1 which comprises the design, assessment, implementation, tracking and support of all phases of the process and changes adopted in installations or equipment, as well as the development of the quality management system. The process starts with an audit phase, in which the installation or the production process is evaluated in-depth, and the subsequent drafting of an Action Plan (CAPA) designed according to deviations detected. The company receives an assessment of the practices implemented by the Quality Management System and the equipment used in production, as well as the utilities involved and the facilities where the production process takes place. At the following stage, a CAPA is undertaken in which the actions are prioritized so that they could be addressed logically and sequentially. Finally, once the corresponding regulatory modifications are adopted, it is the time for the new installation to pass the inspection of the Regulatory Agency, complying with the requirements of the new Annex 1.

Led by Rafael Beaus, Global Consultancy Manager at Azbil Telstar, this service has been set up to respond to the increasing demand of pharmaceutical companies which have decided to move towards adapting their processes to the new requirements and to implement the subsequent solution, which is also perceived as an improvement on current practices which are already applied by large reference laboratories today.