PROCESS LIFECYCLE VALIDATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 205

for multiproduct operations in order to avoid cross-contaminations is shown in
Example 4.
Multiproduct Facility Risk Assessment This RA should be performed during
the introduction of a new product to assess and review any potential cross-
contamination or nonroutine risks of mix-up between existing products at the
facility and the new product. An example of a nonroutine risk is loading of an
incorrect automation recipe as the operator may have recipes for multiple prod-
ucts to select from. On review of these risks, appropriate multiproduct controls
should be identified and implemented, as determined through the RA. If no new
multiproduct risks are identified with the introduction of the new product, the
existing multiproduct RA does not require further update.
Process Change Risk Assessment If any process changes are being made as
part of the transfer, an assessment should be performed to ensure that the process
changes do not introduce any unacceptable quality risks and that proper controls
are in place for the manufacturing process. A PHA, FMEA or FTA may be
used to evaluate the hazards or failure modes associated with differences in the
manufacturing process between the donor and recipient site.
Facility/System/Equipment Modifications for Process Fit The risks associated
with modifications to existing facility, systems, or introduction of new equip-
ment to ensure process fit at the recipient site should be assessed and managed
adequately. Where RAs exist for the impacted system/equipment, they should be
reviewed and updated for any new risks associated with the change being made.
This RA should identify if additional controls or commissioning/qualification
activities are needed to support the implementation of that change.
Analytical Methods Transfer Analytical methods are transferred to a receiving
site to support in-process and release testing. The methods transfer should be
performed in accordance with a methods transfer protocol. The risks associated
with the methods transfer can be assessed through a technical rationale or by the
use of an RA tool similar to a PHA. The results of the RA should help determine
if additional controls are required for transferring and executing the method at
the recipient site.
Risk Control After completion of the RA, decisions need to be taken on further
risk reduction or risk acceptance. It is essential to identify the decision mak-
ers (person with the competence and authority to make appropriate and timely
QRM decisions and document the risk control decisions including the associated
rationale where needed [11].
When a risk scoring methodology is used, the following approach is an
example for determining the order of risk control actions (NOTE: Risk control
includes risk reduction and risk acceptance).