Standard Operating Procedures
ACS Standard Operating Procedures (SOP’s) have been fully validated for the aseptic processing and handling of adipose tissue, stromal vascular fraction and adipose derived stem cells and regenerative cells. In conformity with current cGMP/cGTP regulations and guidance the SOPs cover all daily laboratory operations, manufacturing, biologic processing, equipment operation and maintenance and required record keeping and document control.
The SOPs are generally classified in the following four categories:
Administration SOPS: control the exchange of data inter-office, access to patient records and files and electronic data and the handling and access to privileged and sensitive information.
Operation SOPs: control all laboratory operations that specifically concern individual sample data, laboratory management and cleanliness, as well as all QM/QC procedures. They also cover employee safety and all processes that maintain an aseptic processing environment.
Biologic SOPS: control all biologic preparation, manufacturing and testing processes required to be performed in a sterile environment by a trained technician. These SOP’s and their associated data collection forms are standardized to capture all data and record any deviations in process. The biologic SOP’s govern all in laboratory process including the creation of re-manufactured enzymes, cell culture methods and all in process testing.
Equipment SOP’s: control handle details such as schedules for certification, inspection, qualification and servicing of each piece of equipment, as well as the proper usage of that piece of equipment. All SOP’s have been validated and approved by management of ACS and the laboratory director as required by regulation.