Cobra Biologics’ primary objective is quality: the delivery of quality products to meet our customers’ expectations.
Cobra Biologics’ Keele, Matfors and Södertälje are holders of relevant national authorisations for the manufacture and import of Investigational Medicinal Products. The facilities are routinely inspected by the UK MHRA (Keele) and Swedish MPA (Matfors and Södertälje) to assure that all current Good Manufacturing Practices (cGMP) are followed.
As an international supplier of clinical and commercial materials, Cobra Biologics also complies with all international cGMP requirements, including those of the International Conference on Harmonisation (ICH), US Code of Federal Regulations (in particular CFRs 210, 211 and 600) and where appropriate, those of the World Health Organization.
Cobra Biologics’ Quality Management System includes the following elements:
The Quality Assurance units are separate from Manufacturing. All staff have job descriptions and are suitably qualified and trained to carry out their allocated duties.
All premises and equipment used for the manufacture and testing of clinical materials are constructed, validated, cleaned, classified and maintained in order to ensure that products are adequately protected, eliminating the possibility of contamination.
All equipment used for manufacturing and testing of clinical materials is validated, maintained and calibrated to ensure both reliability and reproducibility of operations.
All manufacturing processes follow a Manufacturing Specification agreed between the Customer and Cobra Biologics. All manufacturing follows, and is recorded on, approved Batch Manufacturing Records (BMRs) such that full traceability of manufacturing operations and conditions are maintained. BMRs are reviewed and approved by both Manufacturing and QA prior to issue and after completion of manufacturing operations.
Cobra Biologics has no products of its own. The list of product types that Cobra Biologics is licensed to produce is listed within the relevant Site Manufacturing Authorizations.
All cGMP manufacturing and testing activities are described in approved procedures and analytical methods. Key quality system procedures include: Training; Validation; Change Control; Deviations; Complaints and Recall; Vendor Assurance; Quality Agreements; Manufacturing Specifications; Analytical Method Qualification; Out of Specification; Product Release.
Product Release and Customer Deliverables
Bulk Drug Substances are released by appropriately experienced and qualified senior members of the QA department. Drug Products, where authorized, are released by EU Qualified Persons named on the relevant Site Manufacturing Authorizations. In addition to the manufactured material, (where specified in the Quality Agreement) Cobra Biologics can supply a comprehensive package of documentation covering all activities pertinent to the manufacture of the batch.