Real compliance and how to achieve it.

Regulatory compliance is designed to comply with regulations and guidelines to avoid regulatory citations. While it is designed to minimize compliance problems, it can actually create them by causing a company to aim at constantly moving targets, domestically and internationally. This type of compliance substantially increases costs. Real compliance offers the advantages of regulatory compliance without the disadvantages at significantly reduced costs by increasing production and control efficiencies and reducing training expense. Real compliance is defined as a state of control. It is unconditional since it does not depend on compliance with a particular set of regulations and guidelines. Real compliance is product and process based and results from effective policies, procedures, processes, and warning systems. Real compliance can be achieved by designing systems and procedures to contain the characteristics outlined in the elements of a state of control listed above. The following points should be considered as you transform regulatory compliance to real compliance. Knowledge plus control equals compliance Build effective processes and monitor them Cease dependence on inspection to achieve quality Develop and implement effective quality systems Systems and procedures should be principle-based, not rule-based Hire the best people, train them and keep them Have enough staff Build an "immune system" Never guess.

Simultaneous quantitative GLC determination of chlorpheniramine maleate and phenylpropanolamine hydrochloride in a cold tablet preparation.

A GLC method was developed for the simultaneous determinations of chlorpheniramine maleate and phenylpropanolamine hydrocholride in a cold tablet preparation containing a large amount of aspirin. The method utilizes a solid sampling device to eliminate interference from solvent, and it is rapid and precise. The total analysis time is less than 1.5 hr, thereby permitting its use for quality control purposes.