Certain state regulations draw on some requirements of the Federal Code of Regulations 21CFR Part 211 current Good Manufacturing Practices as relating to documentation and record keeping. Both the 21CFR Part 211 and state regulations have similar requirements for record keeping and policies and procedures. There is a direct transfer of cGMP knowledge, especially around typically required standard operating procedures (SOPs) in a drug processing environment to meet the requirements outlined in the state regulations.
A State regulated medical facility is required to have an operating manual, essentially a Quality System. Such an operating manual requires policies and procedures, which must be developed, approved and managed and Management and staff employees must be trained. Based on certain state regulations stated procedure requirements and interpretation of the regulations, policies and procedures documents are required in the following areas with each area requiring subsections which MEDVACON will share as part of the consulting engagement:
MEDVACON's extensive experience in implementing Quality Management Systems for the pharmaceutical, medical device and biotechnology industries will enable the smooth implementation of your Quality System.
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