All CTQ definitions listed below were generated from a Quality and/or Environmental, Safety and Health viewpoint with the objective that the Quality Plan be compliance directed. Additional viewpoints can be taken into consideration as directed by top management.
Regulations published by the Occupational Safety & Health Agency outlined in 29 CFR, OSH Act of 1970 (General Duty Clause), published interpretations and general industry practice.
Regulations published by the Environmental Protection Agency outlined in the CFR, published interpretations and general industry practice. In addition, any information found within the companies permits, licenses or agreements.
Regulations published by the Department of Transportation outlined in the CFR, published interpretations and general industry practice.
Projects that will greatly impact customer satisfaction and/or sales.
Directives or goals communicated and published standards or policies specified by corporate personnel.
Regulations published by the United States FDA outline in 21 CFR (Parts 11, 210 & 211), guidance for industry, published interpretations and general industry practice.
Initiatives created by the United States Food and Drug Administration beyond regulations, guidance, etc. The firm may have committed to the FDA that certain projects are completed – such as a response to a 483 observation or warning letter.
Regulations published by the United States Department of Agriculture outlined in 9 CFR or directives stipulated in company permits/licenses.
Directives issued by non-US government agencies affecting operations (e.g., EU Certificate of Suitability, MCA).
Regulations published by several US government agencies (i.e., NFPA, NEC, Engineering Standards) that impact facility liabilities.
Free FDA GMP Training Success Kit
Compliance Insight has created a free FDA GMP Success Kit to help you implement your GMP program. Click the button below to learn more and download you copy today.
Additional Articles on FDA GMP Compliance