We provide guidance in the design and drafting of Standard Operating Procedures (SOPs), tailored to your actual facilities and processes, with the aim of maximizing product safety, personnel protection, and operational efficiency.
A well-defined procedure not only facilitates regulatory compliance, but also reduces errors and ensures the reproducibility of operations.
We ensure that each procedure is aligned with the physical design of the cleanrooms, workflows, equipment, and regulatory requirements. In fact, we can develop the procedures in parallel to the design of the facilities, which allows a total integration between space and daily operations.
Among the aspects we address:
- Materials flow: Inputs and outputs of materials for correct manufacturing and aseptic processing.
- Gowning and personnel flow: Definition of entrances and exits of personnel, gowning sequences and access control.
- Cleaning and disinfection: Detailed procedures by areas, types of surfaces, products to be used and their frequencies.
- Sterilization cycles: Procedure and validation of autoclave sterilization cycles of materials used in cleanrooms.
- Environmental monitoring: Control and recording of viable and non-viable particles, and response to deviations (OOS, Out of Specification, OOE – Out of Expectation, OOT – Out of Trend).
Our approach combines regulatory knowledge (GMP, Annex I, ISO) with operational experience in aseptic environments and classified areas. In addition, we adapt the language of the procedures so that they are understandable, applicable and easily auditable, facilitating both the training of the staff and the acceptance by the health authorities.