Regulatory Compliance Issues in

Regulatory Compliance Issues in the US Table 64.2 Examples of OSHA-listed chemicals... 

The author acknowledges helpful ideas and suggestions from R. Ornaf, D. Barker, J. Bonilla, and C. Choi of Purdue Pharma. This chapter has been presented in parts in a symposium Regulatory compliance issues in the pharmaceutical industry at the Pittsburgh Conference in Orlando, Florida, March 13, 2003. 

These include, but are not limited to, cGMP and regulatory compliance issues such as the need to provide proper segregation of pre- and post-viral clearance steps, ensure uni-directional flow of material and personnel, cleaning of the facility, waste handling, and environmental monitoring of the facility (37,57). In order to scale-up and transfer a process successfully from laboratory scale to pilot scale and multiple commercial manufacturing scales. 

In conclusion, once the regulatory compliance issues regarding informed consent have been satisfied, it is essential to ascertain the subject s comprehension of the informed consent. Documentation of the administration and comprehension of the informed consent by the subject should be a routine component of the process. 

In short, it is important to manage both the operational elements and the regulatory compliance issues to insure a successful inspection by any regulatory agency. The FDA, World Health Organization, and ICH guidelines related to stability are discussed in detail. 

What regulatory compliance issues there are in making this product,... 

Safety, Health, and Environment—course in which students gain knowledge and skills to reinforce the attitudes and behaviors required for safe and environmentally sound work habits. Emphasizes safety, health, and environmental issues in the performance of all job tasks, and covers regulatory compliance issues. 

Managers favor mandates, reflected in regulatory compliance issues and the common slogan, "Safety is a condition of employment." Mandated behavior is likely to require constant "management."... 

The secretary not only can but must inspect and audit chemical facilities and determine regulatory compliance. If the secretary finds a facility not in compliance, the secretary must write to the facility explaining the deficiencies found, provide an opportunity for the facility to consult with the secretary, and issue an order to comply by a date determined by the secretary. If the facility continues to be out of compliance, the secretary may fine and, eventually, order the facility to close. 

The issues of regulatory compliance, local infrastructure, and logistic concerns cannot be readily changed to achieve vastly different requirements. These concerns need be identified early in a qualification process to assure they are adequately understood and addressed. 

A major compliance issue is the administration of electronic records. Regulatory authorities hold owners of records required by existing regulation responsible for assuring the compliance of the recording and management of the electronic records. The FDA establishes such responsibility in the CPG 7132a. 12, Vendor Responsibility and Part 11 has now established the detailed requirements for such records. 

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