Bio Elpida, CMO for Clinical Batches Manufacturing
From validation and stability to GMP clinical batch production
Following the development stage of your pharmaceutical products, Bio Elpida follows strict procedures to ensure clinical batch production
In accordance with cGMP, we do establish the evidence that procedures, processes, items of equipment, materials, operations or systems do in fact result in the intended outcomes.
Our GMP suites, integrated in the pharmaceutical zone, meet all European GMP regulatory standards. From the one-way flow design for materials and personnel to the equipments we use, the suites are engineered with exceptional quality. Each suite and common areas use fresh air-handling system thus preventing cross contamination. Every suite features its own dedicated cleaning and environmental monitoring equipment, and all have alarmed backup equipment. In addition, the suites' flexibility enables to meet unique customer requirements and optimise productivity.
Bio Elpida takes your product and process protection very seriously. Hence, we are fastidious about protecting and segregating projects. At the end of each project, validation changeover and cleaning procedures are implemented, resulting in optimal quality and leaving the suites available for new projects. Furthermore, Bio Elpida only works with single-use manufacturing processes.
Good manufacturing practices are guaranteed with our internal Quality Assurance System which includes: documentation tracking system, equipment qualification and maintenance, the process and batch recording, people training…
All of this translates into ensuring the integrity of your product and consistently meeting your expectations with efficient systems and high quality results.
According to ICH guidelines (Q1C and Q5C), stability test is necessary for all clinical trial and pilot batch. Such stability test includes assessments of critical parameters such as potency, purity, sterility, bioburden, pH, appearance, general safety, etc
Production and control of Active Pharmaceutical Ingredients
Bio Elpida is equipped with a 150 m2 GMP of production zone dedicated to Pharmaceutical Active Ingredients (API). This GMP zone is associated with its dedicated quality control laboratory.
Manufacturing and control of clinical batches
Clinical batches are intended for a predefined number of patients and are manufactured in the pharmaceutical laboratories that are certified by ANSM (French Medical Regulatory Agency):
- Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications
- Manufacturing processes are controlled, and any changes to the process are evaluated
- Changes that have an impact on the quality of the drug are validated as necessary
- Instructions and procedures are written in clear and unambiguous language
- Operators are trained to carry out and document procedures
- Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected
- Deviations are investigated and documented