Focus on training of personnel in draft Annex 1 of the EU Guidelines for GMP
February 9, 2018
On 20 December 2017, the European Commission published the long-awaited revision draft of Annex 1 "Manufacture of Sterile Medicinal Products" of the EU Guideline for good manufacturing practice for drug products and drug substances.
In this new guideline, there are some interesting parts on training of personnel, especially clean room staff. It is stated that all personnel (including those performing cleaning and maintenance) should receive regular training, qualification and assessment in disciplines relevant to correct manufacture of sterile products.
Biotech Training Facility is the partner for you to train your personnel in the following mandatory areas:
1. Cleanroom practices/Hygiene (incl. gowning)
2. Contamination control:
3. Aseptic techniques
4. Potential safety implications to the patient of a loss of product sterility
5. Basic elements of microbiology
Furthermore, the new guidelines state that compliance with aseptic gowning procedures should be assessed (periodically) and confirmed (both visual and microbiological). Only trained personnel who have passed amongst others the gowning assessment should be allowed in grade A/B area. Your personnel can be trained in your aseptic gowning procedures and be qualified at Biotech Training Facility, or we can come to your location and train your personnel.
In addition, Biotech Training Facility provides also custom-made training on all these and related topics. Please contact our team if you are interested to learn more about this service:
tel. nr.: 0031 (0)88 28 30 100
For more information on the new guidelines: https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf)