hree base
ingredients are needed for a firms quality program to be successful. The first is to have
understandable and technically correct Standard Operating Procedures (SOPs) that are complaint
with current regulations. The second is an ongoing training program in those SOPs as well as
the regulations applicable to the firms operations. Although all employees believe they are
doing things correctly and management should expect that SOPs will be followed and all
regulations complied with, one must periodically verify these conditions through audit and
assessment.Gas Regs, Inc., can assess your firms FDA related activities by reviewing your SOPs and conducting facility and operations audits. Audits not only assure your "paperwork" is in order, but also verify that your personnel conduct physical operations in accordance with current industry and regulatory practice and that your SOPs reflect actual practice.
Operational audits include audits of (1) suppliers to medical and food grade gas manufacturers, fillers, distributors and users; (2) compressed gas container and equipment manufacturers; and (3) drug and device manufacturers, including contract manufacturers. Gas Regs, Inc. also will conduct mock FDA inspections (both CGMP and QSIT).
