Biomedical Engineering Reference
In-Depth Information
• details of segregated areas and personnel flow;
• routes of potential cross-contamination;
• flow of raw materials and packaging materials;
• facility HVAC and utilities; and
• personnel hygiene and uniform requirements;
11.3.4.4 Verify the Process Flow Diagram After the process flow diagram was
constructed, the HACCP team performed an on-site review of the operation to
verify the accuracy and completeness of the flow diagram. Any deficiencies or
modifications were documented in the process flow diagram.
11.3.4.5 Principle 1: Conduct a Hazard Analysis Principle 1 consists of the
following:
• Conduct a hazard analysis.
• Identify preventive measures.
11.3.4.6 Conduct a Hazard Analysis Hazard analysis is a two-phase exercise.
The first phase is to develop a list of steps in the process where hazards, which
could result in injury or illness if not controlled, could occur. In the second phase,
the hazards are evaluated to determine which must be part of an HACCP control
plan.
The HACCP team reviewed the ingredients used in the product, the activities
conducted at each step in the process, the equipment used, and the final product.
On the basis of this review, the team listed all of the microbial hazards that
may be reasonably expected to be introduced, increased, or controlled at each of
the steps identified in Figure 11.2, and listed in the following:
• raw materials (API and excipients);
• pre- and post-manufacturing storage;
• dispensing;
• granulation;
• drying;
• milling;
• blending;
• compression;
• film coating;
• branding; and
• packaging.
In addition, the following areas were also considered for potential microbial
hazards:
• sampling;
Search WWH ::




Custom Search