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Telstar has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the EU GMP Annex 1 guidance.
Telstar has announced, in a Sept. 17, 2020 press release, that it has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the European Union Good Manufacturing Practice (GMP) Annex 1 guidance.
The strengthened service specializes in assessment, diagnostic, and implementation of comprehensive solutions for sterile process and critical installations. Focused on helping pharmaceutical laboratories with sterile production to drive strategies and technologies integration, the specialized service is aimed at assuring the sterility of finished products in line with the new Annex 1 requirements.
At the time of writing, the new Annex 1 guidance is under formal review, with expected enactment of regulatory requirements to happen over the next few months. The changed guidance is aimed at preserving safety throughout the whole manufacturing process and requires companies to formally document a contamination control strategy, which considers all technical and organizational measures in place to ensure sterile products meet quality critical attributes.
The complete service offered by Telstar comprise the design, assessment, implementation, tracking, and support of all phases of sterile medicine manufacture and changes adopted in installations or equipment, in addition to the development of the quality management system. The service will be led by Rafael Beaus, global consultancy manager at Azbil Telstar.