PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 303

include sampling and analytically testing products, reviewing monitoring records
and deviations, or auditing monitoring procedures or manufacturing operations.
Verification is an ongoing process and the HACCP team must continue to update
the HACCP program if there are any changes in the processes or materials.
Verification activities should be established through procedures. Procedures
should define the types of verification activities that will be performed and
describe a plan when to conduct these activities. An example of a verification
procedure that describes the verification plan is documented in Table 11.3. The
table defines for each verification activity (initial, subsequent, or comprehensive
verification or record review), the frequency or conditions under which a verifi-
cation activity needs to occur, the person or persons responsible to perform the
verification activities, and the reviewer of the completed verification results. For
example, the chart defines that there will be a monthly review of the monitor-
ing records, corrective action reports, and internal or external audit or regulatory
inspection findings by the Quality Department and reviewed by the Operations
Manager. This review verifies that the controls already in place and the correc-
tive actions taken in response to issues were effective and adequate to control
the hazard. If not, further action should be taken.
11.3.4.13 Principle 7: Establish HACCP Program Documentation and Record
Keeping It is essential that the HACCP program is documented. Documentation
of the HACCP program provides an organized plan of procedures and the ratio-
nale for maintaining control of a manufacturing process. In addition, a summary
of the team deliberations and the rationale developed during the hazard analysis
should be kept. This information will be helpful for future reviews and could be
helpful during regulatory inspections.
Examples of documentation are as follows:
• hazard analysis;
• CCP determination;
• critical limit determination;
• SOPs; and
• team meeting minutes.
Record keeping of the process monitoring activities is essential to the applica-
tion of HACCP and should be designed to be easy to complete. Record keeping
should include information that provides feedback that critical limits are con-
sistently being met using the current procedures. The information obtained from
process monitoring lends support to product testing, can be used to justify reduced
final product testing or justify a decision not to perform noncritical process mon-
itoring, e.g., environmental monitoring.
Examples of records are as follows:
• CCP monitoring activities; and
• deviations and corrective actions.