GMP Compliance Adviser Update No. 10/2017

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

11.C Production hygiene
11.D Hygiene plan

GMP in Practice

Chapter 11 Production

11.C Industrial Hygiene

Personnel is not the only source of contamination during manufacture. Other sources include the premises and facilities, starting materials, packaging and aids, as well as gases, ambient air and the processes themselves. For this reason, the cleaning and disinfection of the machinery and premises using suitable agents in accordance with defined validated processes is extremely important. Effective training of certain aspects of cleaning and disinfection is important when establishing robust processes. (Christian Gausepohl, PhD)

11.D Hygiene plan

The hygiene plan is used to define the hygiene measures that are required in the workplace. The hygiene plan contains personnel hygiene plans and assigns the individual rooms of the manufacturing site to specific cleanliness classes. Cleaning and disinfection plans are also included. They regulate what is cleaned and/or disinfected, how often, using what and how the actual processes are carried out.

The hygiene plan deals exclusively with the cleaning of rooms and surfaces that do not come in contact with product. The organisation of room cleaning begins by assigning the production rooms to the individual hygiene zones or clean room classes. The limit values permitted for each zone must be specified. All authorised cleaning and disinfecting agents must be specified in a list. This also applies to the aids that are used. The details affecting general room cleaning can be summarised in a table. The room cleaning documentation should ensure that the cleaning status of a room can be checked at any time. The person(s) who carried out the cleaning and/or disinfection process, and when and how it was carried out should be clear from the documentation. It should also facilitate the traceability of the activities before cleaning was carried out.

During the periodic evaluation of the overall status of a room, monitoring data should be examined along with the room documentation. The rooms should be inspected on a regular basis using hygiene checklists. (Christian Gausepohl, PhD)