PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 271

regulators with greater assurance of a manufacturer's ability to deal with poten-
tial risks. The use of risk assessment tools provides a good structure for prompt
and adequate documentation of the information gathered and justification for the
decisions made during the risk assessment process.
11.2 RISK ASSESSMENT IN PHARMACEUTICAL MANUFACTURING
Pharmaceutical manufacturing has a broad scope that includes many different
types of drug products that can be administered differently and manufactured
under different conditions. Drug product formulations range from powders, liq-
uids, solids, creams, to ointments that can be administered as oral, parenteral,
topical, transdermal, or inhalant. Each dosage form can be manufactured using
different process steps and under different environmental conditions ranging from
aseptic to nonaseptic, with varying levels of control depending on the risk of
microbiological contamination to product quality. Some processes may not be
aseptic but still have a requirement for bioburden control. For example, antiacids,
some liquids, respiratory therapy products, or even terminally sterilized products
are not manufactured aseptically, but there may be microbiological contamination
risks to product quality.
The different combinations make it difficult to discuss in one chapter the
risks associated with all product types included in the scope of pharmaceutical
manufacturing. Risks associated with product quality and safety for one product
type may or may not apply to another. For example, the risks impacting product
quality in the manufacture of parenteral products where sterility is required for
patient safety would obviously differ from risks in the manufacture of solid
oral dosage products where sterility is not required for patient safety. Likewise,
within one product type, some of the risks impacting product quality may be
the same, while other risks may differ because one or more process steps differ.
For example, the risks associated with the drying and milling process steps for a
solid oral tablet may differ from the same steps for another solid oral tablet. The
versatility of the risk assessment process is that it can be applied to manufacturing
process steps for any product type.
The exercise should be product- and process-specific so potential risks are not
missed. Ideally, a risk assessment would be performed for each product, but prod-
ucts that use the same operations can be grouped into families so that knowledge
from common or shared process steps may be leveraged. For a company that
manufactures more than one product, the initial step would be to identify each
of the products, the process steps for each, and any shared or common process
steps between products to help leverage common process risks across the differ-
ent products. It would be important to document the criteria used and justification
to group products into families in case questions or issues arise later on. Each
risk-based assessment should be documented, and the results and conclusions
approved by the site quality and production authorities.