Regulatory Affairs & Quality Assurance

Kimal is dedicated to ensuring that we fully meet all the legislative and code of practice requirements that are commensurate with the performance of a quality driven commercial medical devices organisation.
To ensure our products are safe and fully meet legislative requirements both in the UK and Internationally, Kimal Quality & Regulatory department manage quality of production, medical device vigilance and regulatory affairs. Kimal is able to provide a traceable process of application from source to delivery for all our products.
  What do the Quality & Regulatory department do?
  • Quality Control
  • Device Vigilance
  • Regulatory Affairs
Quality Control
Quality Control department is a support function to aid the production of Kimal products and to ensure that the highest level of quality is achieved with constant focus on customer satisfaction. The main areas of focus for the Quality Control department are as follows:
  • Goods inward inspection
      To ensure that products which are received at Kimal meet the level of quality expected and meet the specification detailed on product drawings, technical specification and product sample supplied by the supplier.
  • Supplier communication
     
    Once issues are highlighted these are to be addressed with the supplier so that corrective actions can be implemented and that defected parts can be returned for replenishment stock or for credit.
  • Quality management system
     
    As part as Kimals on-going approval Kimal must maintain an up to date quality management system in accordance with EN ISO 9001: 2008 and ISO 13485 2003 which is reflective of Kimals’ internal processes. Kimal are audited on a regular basis by our regulating body who are the LRQA to determine whether Kimal are compliant to the standards.
  • Quarantine of stock
     
    Once issues are highlighted defect products are to be kept in quarantine until they are to be returned or disposed of, this is so defect products are not used in production by mistake.
  • Calibration
     
    The process of calibration is carried out to ensure that any piece of equipment which is used to measure, weigh, time e.t.c is validated at periodic intervals. This can be done either internally or externally.
  • Routine bio-burden testing
     
    Random products of different materials i.e. Polythene, polypropylene and stainless steel are sent to an external test house on a monthly basis to test them for varying levels of bacilli, micrococci and staphylococci to help with the constant monitoring of environmental changes.
  • Air testing
     
    On a weekly basis all clean rooms are tested for increased levels of bug counts in the air, this is carried out to help with the continued monitoring of clean room cleanliness if levels reach an unacceptable limit then the clean room in question will stop production and immediately execute an emergency clean down, once complete the room will be retested and our retained micro-biologist will be informed.
  • Internal audits
     
    It is also a function of the QC department to ensure that all areas of the business adhere to a set list of processes and procedures outlined in the quality manual and detailed in the quality management system, the internal audits are carried out to help highlight any areas where this is not happening.
  • Testing
     
    Testing is carried out both internally and externally such as real age testing, accelerated age testing, tensile testing, validations, stability studies and new equipment trials.
  • Monthly figures
     
    On a monthly basis the quality department figures are submitted at the business unit leaders meeting detailing supplier defects and overall supplier performances which is continually monitored.
Regulatory Affairs
The Regulatory Affairs team ensures that all our products are registered on a UK & International basis in accordance with the legislation required in each specific region or country. In the UK we comply with the requirements of Lloyds Quality Regulatory Assurance (LRQA), the Medical & Healthcare Products Regulatory Agency (MHRA) as well as European & International medical directives.  
  • CE marking process.
  • Company global registrations.
  • General corporate governance.
Medical Device Vigilance
The team ensure that all our products are both  ISO 9001:2008 and ISO 13485:2012 compliant. As well as making sure that we are at one with any relevant medical device directive. Additionally, if any issues are raised in respect of customer use of our products, then all investigations and correspondence are handled here. We feel it important that all customers are confident in our commitment to compliance; therefore you can view and download our ISO certificates: Wholesale Dealer's Licence
Kimal hold a Pharmaceutical Wholesale Dealer’s Licence. The Wholesale Dealers Licence permits us to store and distribute pharmacy-only-medicines (P) and prescription-only-medicines (POM). Our Licence Number is WL/14163, and was granted to us by MHRA. All the controls and working practices required by the licensing authority have been defined and embodied within our Quality Management System (QMS). Our QMS is routinely audited to ensure we continue to comply with the requirements of our Wholesale Dealers Licence.
Manufacturer Dealers Licence
Kimal hold a manufacturers dealer licence which enables us to;
  • manufacture and/or assemble (package) medicinal products
  • wholesale deal licensed medicinal products imported from countries outside the EEA
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