The facility has two clean rooms.
The overall facility is made up of unclassified, clean and sterile areas where we carried out Pre-validation works to ascertain the clean room status. This highlighted a number of items that required addressing to ensure compliance with the different territories to which the pharmaceutical company supplies the products.
As a result of our Pre-Validation findings, we were involved in a number of consultations with the client where we were able to advise on required works to rectify the issues within the time frame to keep in line with production. The required works included filter changes and recommissioning works.
Our commissioning and survey works were conducted in accordance with the current guidelines and regulations including:
Our test sheets and documentation were fully compliant with the Good Manufacturing Process (GMP). Due to our successful Pre-validation, recommissioning, consultation meetings and reporting Banyards have been asked to undertake 4 revisits per year to help maintain and advise the client with the ongoing operation of their facility.