If it is in fact relatively easy to reuse a validation protocol for a room or an equipment, it is not certain that this is aligned with the requirements of the new versions of rules and standards that are issued: - 2009 EN 1822-1 (UNI EN 1822-1: 2010), High efficiency air filters (EPA, HEPA and ULPA). Part-1 Classification, performance testing, marking
- 2015 ISO 14644-1, Cleanrooms and associated controlled environments. Part-1 Classification of air cleanliness by particle concentration
- 2015 ISO 14644-2, Cleanrooms and associated controlled environments. Part-2 Monitoring provide evidence of cleanroom performance related to air cleanliness by particle concentration
- EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, ANNEX 1: Manufacture of Sterile Medicinal Products
ENGINEERING CHANGES Adeodata is able to provide support to companies even in the event of engineering changes: department layout change, new department, equipment change, insertion of a new machinery, change of utilities, movement of equipment with or without modification of the intended use. Support for engineering changes COMPETENCE AND EXPERIENCE Right here Adeodata makes the difference. Adeodata established the figure of the SME - Subject Matter Expert, a person dedicated to: - study the regulations (and related updates);
- update internal standards, also in light of the experiences on the latest generation of qualified equipment;
- instruct all consultants on these standards.
The figure of the SME for Adeodata is the basis of the quality system procedures, certified ISO 9001: 2015. INSTRUMENTS The instrumentation of Adeodata is regularly calibrated. Its software is validated and used in accordance with Data Integrity requirements. |
