(2006; 23 pages)
Active Pharmaceutical Ingredients
Manufacturers supplying various types of industries
Imports through brokers
Unsatisfactory final facilities
Possible situations that might be experienced include:
Manufacturers that are not prepared to provide the standards needed for pharmaceuticals.
Manufacturers may not be interested in supplying the pharmaceutical industry.
Manufacturers who refuse to accept inspections.
Sometimes the only route to obtain supplies is through the use of brokers. They may be unwilling or unable to identify their suppliers. They may not use the same supplier on a regular basis.
It may be that the process is so hazardous that inspection during manufacturing is not possible.
A company may state that it will not permit an inspection because of commercial secrecy about the process.
A frequent situation is that the final processing conditions do not match those required for the processing of the finished pharmaceutical form. The company refuses to make the investment needed.