cobra:bio

Cobra Biomanufacturing Quality Policy

Cobra’s primary objective is quality: the delivery of quality products to meet client expectations.

This dedication to excellence carries through every aspect of Cobra as a company, from the premises, equipment and technical systems we use to manufacture biopharmaceuticals to the staff, procedures and project management in place to carry out manufacture and supply to the global Life Science industry.

Cobra is the holder of a UK Medicinal Healthcare Products Regulatory Agency (MHRA) Manufacturers and Importers Authorisation for investigational Medicinal Products and is routinely inspected to ensure we follow Good Manufacturing Practices (cGMP).

Cobra also complies with all relevant European and UK national regulations and guidelines relating to the manufacture of materials for clinical use and, where appropriate, all international cGMP requirements and those of the World Health Organisation.

Cobra’s Quality Management System includes:

People

The Quality Organisation (incorporating both Quality Assurance and Quality Control) is separate from Manufacturing and reports to a Corporate Director who in turn reports into the Board.

All staff have job descriptions and are suitably qualified and trained to carry out their allocated duties.

Cobra’s QP personnel are registered Permanent Provisions QPs, a qualification endorsed by professional bodies. The Institute of Biology, Royal Society of Chemistry and Royal Pharmaceutical Society of Great Britain.

The Director of Quality Assurance has over 25 year’s experience in commercial manufacture in both FDA and MHRA inspected sites.

An on-site Pharmaceutical Lead Auditor ensures compliance to MHRA GMP standards through the inspection of quality systems used internally and those used by our external suppliers.

Premises

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.

Equipment

All equipment used for manufacturing and testing of clinical materials is validated, maintained and calibrated to ensure both reliability and reproducibility of operations.

Processes

All manufacturing processes follow a Manufacturing Specification agreed between the Client and Cobra. 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 issued by Quality Assurance (QA) and are reviewed and approved by both manufacturing and QA after completion.

Products

Cobra has no products of its own. There is therefore, no conflict between Cobra’s own products and those of its clients. The list of product types that Cobra is licensed to produce is listed within the Manufacturing Authorisation.

Procedures

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; Technical / Quality Agreements; Manufacturing Specifications; Analytical Method Qualification; Out of Specification; Product Release.

Product Release and Client Deliverables

Bulk Drug Substances are released by appropriately experienced and qualified senior members of the QA department. Drug Products are released by EU Qualified Persons named on the MIA(IMP). In addition to the manufactured material, (where specified in the Quality Agreement) Cobra can supply a comprehensive package of documentation covering all activities pertinent to the manufacture of the batch.

"Cobra has an impressive track record in the safe and effective manufacture of diverse biologicals.."

Dr Gerd Ritter
Associate Director, Ludwig Institute’s Office of Clinical Trials Management

Quality Policy 2007
234kb PDF

16 independent facility audits were performed in 2007 at Cobra

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