For automated production controls within a Pharmaceutical, Healthcare or Lifesciences plant, the availability of accurate, regulatory compliant documentation, written to ISPE GAMP 5 (Good Automated Manufacturing Processes) standards, drives the whole project.
Denca has recently completed a large project for a major company in the healthcare sector. The development of a new and advanced wound care product by the company led to their site needing significant upgrades. While centred around new plant installations, the project also recommissioned and upgraded existing automated manufacturing systems which were then integrated with the newly created plant and control systems.
Production Area Upgrades
The extended production facility included re-instating an unused existing production area which was brought up to date with new equipment and electrical controls. These new controls included safety PLCs and Control Panels as well as extensive bespoke software controlled through SCADA screens. Finally, integrating the controls with other production facilities across the factory created the onsite supply chain for the new advanced product.
The customer uses solvents extensively across the site. Consequently, the new production area and those linked to it needed correct Safety Integrity Level (SIL) ratings. Qualified and experienced technicians from Denca’s in-house instrumentation department carried out the SIL rating work.
Since completion of the SIL ratings was the trigger for the work of creating the project documentation, this drove everything connected to the project.
Extensive Documentation
The project demanded extensive and highly detailed documentation as FDA, European and British rules applied. Additionally, GAMP 5 good practice guided the design and implementation at every stage of the project.
In all, Denca produced over 100 detailed documents covering the new plant and also to the existing manufacturing facilities linked to the new wound care product. While many were newly created documents, others were updates to existing records. Furthermore, a third group were existing documents that were completely re-written to meet the requirements of the project. This comprehensive approach ensures the upgraded system is fully compliant, delivering the standards of automation as guided by GAMP 5.
Furthermore, the manufacturer went to great lengths to work with Denca to ensure that their plant met these expectations.
In total, the documentation package ran to more than 100 individual documents covering the specification, design, build, and commissioning of the project.
Extensive Regulation
The documentation produced by Denca not only had to follow GAMP 5 guidelines but also the whole project had to comply with Federal, European and UK regulations including the following:
- Code of Federal Regulations, 21, Part 820, US Food and Drug Administration, Subchapter H – Medical Devices, Quality System Regulation.
- Code of Federal Regulations, 21, Part 210, US Food and Drug Administration. Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs.
- EU Directive 2001/83/EEC; The Rules Governing Medicinal Products in the European Community, Volume IV, including Annexes, Commission of the European Communities.
- Code of Federal Regulations, 21, Part 211, US Food and Drug Administration, Current Good Manufacturing Practice for Finished Pharmaceuticals.
- Code of Federal Regulations, 21, Part 11, US Food and Drug Administration, Electronic Records; Electronic Signatures.
Other notable regulations covered by the documentation include:
International Conference on Harmonisation of Technical Requirements for Registration for Human Use (ICH): ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q9 Quality Risk Management.
International Society for Pharmaceutical Engineering, ISPE Baseline Guide Volume 5, Commissioning and Qualification, First Edition, March 2001
Rules and Guidance for Pharmaceutical Manufacturers and Distributors, 2015 (“The Orange Guide”).
BS EN ISO 14644, Clean Rooms and Associated Controlled Environments.
BS EN ISO 11137, Sterilisation of Health Care Products – Requirements for Validation and Routine Control – Radiation Sterilisation.
More than just documentation
In addition to producing the comprehensive documentation, the Denca team undertook a significant part of the design and build work including:
- Project design
- Bespoke software
- Control Panel design & build
- System build and installation including Pneumatic Panels, PLC and SCADA systems.
Denca also completed all testing and commissioning.
This project reflects Denca’s commitment to ensuring a complete job is handed over to our customer ready to deliver the performance they are looking for, backed up with the documentation to support that performance into the future.