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)
Cleanroom behavior course 14 March
Cleanroom behavior course including gowning qualification: 12 September

2. Contamination control:
Pharmaceutical Microbiology- How to prevent contamination?: 17 & 18 April
Sterilization – too hot to handle?: 12 & 13 June

3. Aseptic techniques
Aseptic manufacturing using an Automatic Filling line: 27 & 28 March
Aseptic techniques in a downflow cabinet: coming soon!

4. Potential safety implications to the patient of a loss of product sterility
GMP Mid-Level: Ins and outs: 20 & 21 March
Pharmaceutical Microbiology- How to prevent contamination?: 17 & 18 April

5. Basic elements of microbiology
Pharmaceutical Microbiology- How to prevent contamination?: 17 & 18 April

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:

info@biotechtrainingfacility.nl
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)