The high profile of H1N1, and earlier threats from H5N1 and SARS (severe acute respiratory syndrome), have raised awareness of the damage widespread employee illness could cause to pharma companies’ manufacturing operations.
To mitigate against this threat the US Food and Drug Administration (FDA) recommends manufacturers of MNPs formulate a plan. MNPs are defined as serious disease treatments which cannot be substituted with an alternative product.
In its draft guidance the FDA states that the plan should be developed and tested before a crisis occurs. Failure to do so could lead to companies developing plans during a pandemic, when there may be insufficient time and management resources.
Furthermore, the agency recommends that if manufacturers can foresee a period of high absenteeism they should begin preparations. These steps include increasing the inventory of MNPs and raw materials, training personnel for different roles and conducting maintenance.
The guidance lists periodic maintenance as one of the activities that could be ceased in the event of high absenteeism, along with some stability testing, environmental monitoring of facilities and examinations of data.
Making these cutbacks is intended to focus resources on essential manufacturing steps. If these are insufficient the FDA suggests companies could reduce second-person verification activities, delay deviation investigations of minor events and cease in-process adequacy of mix tests.
Implementing these measures, and others listed in the guidance, could result in the manufacturing process failing to meet all statutory and regulatory requirements.
However, the Center for Drug Evaluation and Research (CDER) “is prepared to exercise enforcement discretion” in the event of high absenteeism, as long “as the product remains safe and effective”.
To ensure this goal is achieved the FDA recommends that manufacturers carefully monitor indictors of product quality to note unfavourable trends. Furthermore, manufacturers should keep samples for testing at a later date if it cannot be performed at the time.