Quality control regulatory approval

Contracting out of activities previously only conducted in-house is already becoming quite common and will probably continue to develop. In the past a so-called full-service pharmaceutical company took direct responsibility for all the activities required for the formulation, manufacture, quality control, and regulatory approval of its drug products. Nowadays the use of specialist contract houses to perform activities such as formulation, analytical methods development, manufacture of clinical trials supplies, supervision of the assembly of an NDA, postmarketing surveillance, and even troubleshooting may be contracted for even by some of the largest companies. 

Regulatory status In 1998, Lopez Canyon Sanitary Landfill received conditional approval for an ET cover, which required a minimum of 2 years of field performance data to validate the model used for the design. An analysis was conducted and provided the basis for final regulatory approval of the ET cover. The cover was fully approved in October 2002 by the California Regional Water Quality Control Board—Los Angeles Region. 

The decision to approve a new drug is made by a national regulatory body (Food Drug Administration in the U.S.A., the Health Protection Branch Drugs Directorate in Canada, UK Europe, Australia) to which manufacturers are required to submit their appUca-tions. AppUcants must document by means of appropriate test data (from predinical and clinical trials) that the criteria of efficacy and safety have been met and that product forms (tablet, capsule, etc.) satisfy general standards of quality control. 

But DSHEA is very different then the standard approval process for drugs and medical devices, and emphasizes the regulatory enforcement of label claims and advertising and marketing issues rather than the efficacy and quality of the supplements themselves. Unlike new drug and medical device applications, controlled clinical trials aren t part of the supplement review process, nor is any FDA inspection of a company s manufacturing facilities or quality control systems. 

Similar to the methods validation protocol, it is recommended to obtain approval signatures from both the director of quality control and quality assurance because of the regulatory criticality of a method transfer exercise. 

Poor characterization of the physicochemical properties of liposomes Liposome behavior in vitro and in vivo is critically dependent on their physicochemical properties. Therefore a full physicochemical characterization of pharmaceutical liposomes is required in early stages of a development program (Table 5.6). In later development stages, these quality control assays can be used to obtain regulatory approval and to ensure batch-to-batch consistency. 

Required reporting of changes in equipment, manufacturing processes, personnel establishment of formal quality control procedures and submission of samples for regulatory inspection and approval for release... 

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