Good Manufacturing Practice UK
Our Quality system is your Quality System
White Antibodies work within the spirit of GMP (Good Manufacturing Practice)
Our Quality System is based on a series of SOP’s (Standard Operating Procedures) to ensure that a high level of quality and consistency is maintained at each stage of our manufacturing process.
Our SOP system incorporates other key aspects that we consider important in maintaining our high standards, for example Staff Training and on-going assessment is added as a key section within each SOP.
Likewise COSHH assessments will be included in the most relevant SOP.
We will adapt or write new procedures to meet the specific needs of our customers, in each case we can treat specific procedures as confidential.
Key to the workability of our system is a summary display document which is appended to our SOP, this eye catching display is laminated and in full view at the most relevant work station acting as a reference and reminder to technicians carrying out quality tasks.
Key Recording – recording documents are appended to each SOP which are printed and completed on the day of each batch recording.
Quality is everyone’s responsibility
Process Operating Instruction (POI)
SOPs form the backbone of our system and are used for day to day routines and the service aspect of our business however where we are manufacturing our own products we use POI’s.
POI’s require signage (and/or counter signage) at many steps of the process to ensure each step is followed precisely and each Technician takes responsibility for each action.
Every piece of Equipment used during each batch run will require recording in each POI batch document prior to use to ensure calibration data is complete and equipment can be traced to a National Standard.