The training course "Current requirements for cleaning validation" was provided by Honeyman Limited Group on 06-07.06.2017 in Barnard Castle, Great Britain. Coach: Quality Director at Honeyman Group Limited, Qualified Person Marie Westgarth.
The course was attended by specialists in the field of validation from different pharmaceutical companies and cities in the UK and a representative of Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines – Deputy Head of Validation and Reference Standards Department, Head of the direction of Industrial Standardization and Validation, PhD, Natalia Volovyk, who was the only foreign delegate. The high level of trust in the event is evidenced by the experience of the UK participants in the field of cleaning validation – 8 to 20 years.
The training covered topics such as compliance with regulatory expectations, taking into account new recommendations published in ANNEX 15 of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use in 2015, effective cleaning and disinfection procedures, development of effective analytical methods, validation and control of these procedures. During the course, participants received information about the current best practice, cGMP expectations, industry trends and regulatory issues for both the EU and US markets. 50% of the course took lectures and the rest of the time was devoted to practical exercises and interactive workshops. Within the training, there was a practical lesson on the direct surface sampling and analysis of samples.
The two-day course allowed the participants to improve their qualifications and gain the experience necessary to provide services and carry out work on the cleaning validation of pharmaceutical equipment at a high international level. Having completed the training course, the participants earned certificates.