Our department is responsible for the process documentation of the whole of production, from the moment we receive the plasma from our warehouse, right through to final product packaging. Each little step in our processes is captured in the so-called batch record. We have different products in different concentrations, and for each product we have different process steps. Production operators have to make manual records to demonstrate that all the steps are defined and were taken correctly. All the temperatures and parameters must be documented, and who did what and when. We have to have those records to have the complete, fully traceable history of each and every production batch.
Good manufacturing practice (GMP) is the minimum manufacturing requirement to ensure safe, high quality products for patients. There are various guidelines from different countries, but all guidelines follow the same basic principles: manufacturing facilities have to be clean and hygienic with controlled environmental conditions and manufacturing processes must be clearly defined. Also, all processes have to be validated and the instructions and procedures have to be written in clear language. Work instructions provide step by step directions for what to do for each process, e.g. raise the temperature in the tank from 2 to 5ºC.
In addition, our operators have to be trained to carry out and document procedures. Part of my role is to conduct the training of all new production operators. I take them on a tour through our production floors, so they can see and understand all the different steps and departments, not just the one in which they will be working. I also explain to them the clean room procedures and give them a general GMP training to make them aware of how important it is. And when the standard operating procedures are updated, the staff are trained on these changes, too.
The batch record gives us the complete, fully traceable history of each and every production batch.
Our products aren’t transformed from plasma to final product in a single process. Our intermediate products are frozen and stored for further processing at a later stage. This means that for each product, we have more than one batch record. In one week, we have more than 100 batch records to review. A preliminary check of the batch records is done by the head of the respective department. I then conduct the batch record review, checking all the batch records for GMP compliance, conformity and completeness. This includes checking that all the information is contained in the batch record, checking that all the fields are filled in, that the stamps are legible, if all the times are documented and that all the records for the different machines are included. The closer we come to the final product, the more automated the steps, so some of our processes produce electronic files or records, like the chromatography systems, which are used in purification.
I also conduct “GMP walks” in the production area, to check that everything is as it should be, e.g. that operators are correctly dressed, that operating procedures are present, clear and up to date, and that all the log books have been filled in correctly. Each month we have a couple of inspections from regulatory authorities during which inspectors check what kind of control systems we have in place and that all our actions and processes are compliant.
There is of course a lot of routine work with batch record reviews, but I also support projects, e.g. the extension of basic fractionation in Vienna. I am supporting the planning by providing information about the different process steps. We have a really great team as well as a lot of interaction with other departments. I enjoy working directly with the production staff, not just sitting in my office doing documentation work. Everyone in the production chain contributes to ensure safe final products. We have great products that really save lives, which motivates me to come to work every day and to make my contribution.