GMP Services
Kanha Limited
Our associated GMP consultants are well versed in servicing clients with regulatory services. Having set up new Pharmaceutical businesses in the UK and Europe as well as establishing various operating licences for premises. Licences included Wholesale Dealing (WDA), Manufacturing and Importation (MIA), Specials (MS) Controlled Drug.
GMP Service
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They are experienced with a variety of clients in Middle East, Bangladesh and India, where projects ranged from independent cGXP audit through to development of full blown Quality Management System. Corporate Policies, Standard Operating Procedures and working Master Forms can be reviewed, drafted, and amended accordingly.
Technology Transfer of equipment and/or the product process and manufacturing can be managed in realistic timelines. Early involvement in such change control activity has been well managed minimising costs of any plant redesign and reducing vital production downtime. Good appreciation of the cost of quality and right first time attitude has reaped benefits in long term operational efficiencies. No laborious, time consuming QC tasks introduced unless truly effective.
GMP has facilitated many successes in raising the standards of existing businesses, from local WHO to a more prestigious UK MHRA, EU EMEA or US FDA standard. Equally, previous work included the development of the Quality Management Systems to meet internationally recognised standards such as ISO9001 Quality Systems and ISO13485 Medical Devices.
Environmental controls including site cleaning and cross contamination control strategy have been considered and proven to minimise all round product and site risks. Associated HVAC temperature and humidity controls will be validated to efficiently meet product, personnel and area requirements. The mapping and monitoring protocols are designed to cover full qualification of latest compliance requirements. Other utilities will be assessed and designed against product manufacturing specifications and capacity requirements of future demand.
Maintenance of licences is often neglected and support programmes for continued compliance can be devised. Key areas benefiting from such support are validation activities of site, equipment, process and cleaning. Associated Risk Management strategy can be reviewed and any necessary Risk Assessments can be completed.
For change control and deviation management, CAPA plans can be reviewed, drafted, evidence collated and effectiveness checked. Qualification of supply is a constant need. Audit and reassessment can be completed for existing material, intermediate or finished product supply.
Overall Site Master File and/or Quality Manual can be prepared and authorised ready for submission for licence application. Other documentation and trending of existing data can be compiled ready for any licence application, variation or associated regulatory inspections.