Request for proposals (RPF) is usually put up by a pharmaceutical company having a drug product looking for a contract manufacturing site. RPF includes all the information about the organization and time & cost involved. It is a crucial aspect that has a major effect on the relationship between the manufacturer and sponsor. The transfer of technology and the cost of commercial products can be adversely affected by a poorly organized RPF. It also has the potential to slow down the process of selecting the best manufacturer. Bilcare, a prominent name in the medicine packaging industry points out the important aspects an organization should ensure while developing a RPF.
A well organized RPF should cover all the information like the manufacturing process involved, the formula used, the use of specialized equipment, raw material and packaging components used, analytical specification & methods, the API safety data and the materials & associated grades or specifications needed. The other details include the size of the bottle and cap, the use of desiccant, the quality control testing required and the regulatory strategy.
All the outsourced activities are controlled and reviewed under the ICH Q10 guidelines. The FDA and ICH requires a technology transfer to achieve product realization through the smooth transfer of comprehensive knowledge of the process and product. Bilcare points out that communication is a crucial part of this process. It is recommended by the FDA as it acts like a quality agreement for stating the responsibilities and roles of each party.
The company focuses on the need for ensuring environment friendly and safety measures in the process of formulization. Bilcare states that these measures can be ensured through a material safety data sheet (MSDS) and Safe Bridge Consultants Potent Compounds Safety Rating, which safeguards the manufacturing employees from all potential risks involve
