Single source drug products

Revalidation of Minor Changes. A minor change to the drug product may require revalidation of only a single validation parameter. For example, a change in the supplier of a cherry flavor for a multicomponent cough syrup would require a revalidation of specificity in the HPLC assay procedure to confirm the lack of interference from the new flavor source. Only if there... 

Secondary packaging components are not intended to make contact with the dosage form. Examples are cartons, which are generally constructed of paper or plastic, and overwraps, fabricated from a single layer of plastic or from a laminate made of metal foil, plastic, and/or paper. In special cases, secondary packaging components provide some additional measure of protection to the drug product. In such cases it could be considered a potential source of contamination and the safety of the raw materials should be taken into consideration. 

C)rug substances and drug products should be presented in a way to provide maximum area of exposure to the source. Photodegradation occurs only on the surface of solid samples (25). The surface area or weight ratio will therefore affect the extent of observed degradation. It is recommended in the ICH guideline that the sample thickness should not exceed 3 mm for solid drug substances. Preparations like tablets or capsules should be spread in a single layer. 

There are three different levels of reimbursement to the patient for different classes of drugs mainstream drugs, prescribed for common chronic and acute illnesses, are reimbursed at a rate of 70 percent. Medications intended for the treatment of troubles and diseases usually not serious are generally reimbursed at a rate of 40 percent (386). The third category, single-source products for serious illnesses, is reimbursed at a rate of 100 percent. 

Single source products are drug products that are the only product approved hy the FDA for that active ingredient, dosage form, route of administration, and strength. 

Although it may not always be possible to control the sources or extraction conditions to produce only a single component, they should be arranged so as to produce, as far as possible, a consistent mixture. Impurity profiles of botanical products are often monitored by a number of anal3hical procedures to ensure product quality. Minor components that have pharmacological activity should not necessarily be viewed as impurities. In some cases, the activity of a botanical or fermentation drug substance may be attributed to a number of components. 

At least in the short-term, conditions in the world s heroin markets will be determined by what happens in southern Afghanistan, as the country was responsible for 92 per cent of global opium production in 2006. For no other drug is production so concentrated in a single area. This concentration went hand in hand with a remarkable long-term progress in eliminating other sources of supply, principally in South-East Asia. Poppy cultivation in South-East Asia is down by more than 85 per cent over the last decade. Between 2005 and 2006 alone, poppy cultivation in South East Asia declined from 35,000 hectares to 24,000 hectares. 

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