It should be noted that when defining parameters and determining the specifications for the various phases in the life cycle of pharmaceutical products, changes often occur.
Adjustments are made at different times in product life cycles depending on changing knowledge. As a result, additional parameters and specifications may be added as products transfer from development into production, but also during pharmaceutical production. Nor can it be ruled out that parameters originally assessed as critical be classified differently when levels of knowledge increase, or be replaced by other parameters.
Specifications are not cast in stone. If routine production shows that process parameters have been set too tightly and justification exists that extending the specification will not impair the defined quality characteristics of the product, a modification of the specification should be possible.
However, selecting specifications that are too narrow for the product as part of the development specifications and if a company is requested to continue these development specifications into routine production, in the worst case this can lead to extreme costs or even to failure after years of development and production. It is not uncommon for specifications to be drawn up based on marketing requirements or with regard to the performance and quality characteristics of competing products that are not feasible in practice. The specifications issued for competing products cannot be achieved if, for example, the equipment used for production is not suitable. Theoretically, appropriate requirements for manufacturing equipment are stated in associated specifications for ordering the equipment from a supplier. However, practice repeatedly shows that equipment was ordered injudiciously and essential requirements are not included or unsuitable existing equipment is used due to cost pressures.
In the case of filling machines, for example, a lack of accuracy can lead not only to commercial losses because the quantities of the drug filled into the primary packaging are subject to high fluctuations, but also from to failure to comply with desired specifications in the manufacturing process (e.g., a certain range for the lethality value F0 during sterilization) or specifications of the design of the primary packaging.
Company management, with its scope for monitoring and decision-making, is often too far away from it to recognize the discrepancy between requirements and their feasibility. Also, employees involved in development and production may be reluctant to point out the problem or take their case to management.
In such a case, clarification by an external consultant, who is not directly associated with internal processes, can ensure timely clarity with regard to requirements and feasible solutions. Early assimilation of the actual situation by company management will then help to avoid unnecessary development or transfer work and save costs.