Pharmaceutical products development program

Before preformulation studies are undertaken, two-way technical communication between the manufacturers of the API (laboratory and plant) and the pharmaceutical product development laboratories must be established (Fig. 1). It should start early and be maintained through-out the product and process development program. 

Safety Production of the requisite drug molecule, called the active pharmaceutical ingredient (API) or bulk pharmaceutical chemical (BPC), may involve materials, solvents, or intermediates that are volatile, toxic, or even explosive. The development program has to determine the appropriate manufacturing processes to ensure that safety is not compromised and the API can be produced and purified to remove impurities and toxic residues. 

Pharmaceutical sponsors may seek advice from the CPMP concerning their development programs. The CPMP has established a seientifie adviee review group to strengthen and widen CPMP input and to guarantee the availability of proper expertise. A standard operating proeedure for dispensing seientifie adviee by the CPMP for innovator medicinal products has been adopted. 

After very successful drug discovery and development programs based on natural products, the pharmaceutical industry, in particular the large pharmaceutical companies, de-emphasized natural product discovery research in the 1990s and early This was caused by the advent of... 

While validation as a discipline is widely known across the pharmaceutical industry, there are still a significant number of instances in which preapproval inspection results or product recalls identify an insufficient validation program as the root cause of the difficulty. Continued awareness of validation requirements and a diligent application of validation principles will thus help to ensure that pharmaceutical products will be able to be developed and produced with the quality and reproducibility required from regulatory agencies across the world. 

The authors concluded that water which cannot be removed at 100 °C is bound in such a way that it cannot jeopardize the pharmaceutical product. Only the free water can diffuse from the stopper to the product. The moisture content is measured by the Karl Fischer method with different temperatures in the oven, 100 °C to determine the free water content and up to 300 °C to measure the free and bound water. The authors suggested developing a similar program for other stoppers, since the time for such measurements is relatively short (1 week) instead of observing the RM in a product over long times. Table 1.15.2 summarizes the results with the stoppers described above. Table 1.15.3 lists the limits of the free moisture content in 2 types of stoppers and for different cake weights under the assumption that a maximum RM increase of 0.5% in the product is acceptable. 

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