Hazard Analysis and Critical Control Points "HACCP"

In one of our previous newsletter editions, we talked about risk assessment. In this edition, we will see how we can apply tools that are mentioned in standards and regulations. Especially HACCP; "Hazard Analysis and Critical Control Points".

ICH guideline Q9 on quality risk management is the most popular guide on pharmaceutical applications to manage risk. After the revision of ISO14644-2 in 2015, risk assessment and particular tools such as HACCP, FMEA / FMECA, PHA, FTA and HAZOP. These tools are not an alternative to each other but once used as a hybrid approach, you can get better results. For example, today we will cover HACCP where we define critical control points. However, if you apply the FMEA; "Failure Mode and Effect Analysis" method to these critical points, you will get the most out of these tools.

What is Hazard Analysis and Critical Control Points (HACCP)?

HACCP is a systematic approach to hazard identification, assessment of risk and control. Today, many facilities in the food industry use it to ensure that all food consumed is safe to eat. But when we look at its background, HACCP originated in the 1960s, when the National Aeronautics and Space Administration (NASA), the Pillsbury Company, and the U.S. Army Laboratories collaborated to provide safe food for upcoming space expeditions. It was decided that NASA’s engineering management requirements, Critical Control Points, would be used as a guideline for this food safety initiative. Critical Control Points (CCP) were used to test weapon and engineering system reliability. By using CCP, NASA and Pillsbury hired contractors to identify and eliminate the “critical failure areas” in the food processing procedures. Later on, the FDA adopted HACCP as a requirement for process control in the food industry. Today, not limited to the food industry almost all industries, including controlled environments, are using this important tool to find, identify and eliminate risk.

7 Easy Steps to Apply HACCP

We can apply the HACCP method in 7 easy steps;

1. Conduct a Hazard Analysis
2. Determine the critical control points(CCP)
3. Establish critical limits
4. Establish monitoring procedures
5. Establish corrective actions
6. Establish verification procedures
7. Establish record-keeping and documentation procedures

The idea here is to follow smooth steps so that the risk identification, monitoring and control can be defined within the same path.

Step #1 Conduct a Hazard Analysis

There are 4 levels of hazard;

1. Extreme

• Intolerable
• Potential for serious injury of death
• Possible catastrophic results
• Difficult to control or monitor
• Requires adverse trend report

2. Major

• Undesirable
• Monitor closely to determine if limits are exceeded
• Remove or reduce

3. Minor

• No harm to the product or user
• Not economical to reduce

4. Minimal

• Not a (critical control point) CCP
• Not economical to reduce

Once the hazard analysis is conducted, focus on extreme and major items. Due to the lack of hazard analysis, most of the time we focus on minor things since they are quite obvious and easy to identify but not a real CCP.

Step#2 Identify Critical Control Points

Follow this decision tree form the FDA to identify your CCP's;

According to the FDA, important considerations when using the decision tree:

• The decision tree is used after the hazard analysis.
• The decision tree then is used at the steps where a hazard that must be addressed in the HACCP plan has been identified.
• A subsequent step in the process may be more effective for controlling a hazard and may be the preferred CCP.
• More than one step in a process may be involved in controlling a hazard.
• More than one hazard may be controlled by a specific control measure.

Step#3 Establish Limits

• One or two level limits,
• Limits may be based on process capability (historical data)
• In-process limits may be set relative to the attribute allowed in the final product
• Limits may be started in regulatory documents (GMP, FDA, etc.)
• Each CCP must have an assigned limit that is accurate, attainable and verifiable.

Step #4 Establish Monitoring Procedure

• Lay out/justify monitoring plans
• Site selection, frequency of testing based on criticality, validation, testing, historical data
• Describe the analysis of monitoring data-tracking/trending.

Step #5 Establish Corrective Actions

• What could go wrong, and how might we mitigate or correct it?
• Anticipate problems, use FMEA, fishbone or fault tree analysis to identify potential excursions and,
• Determine CAPA (Corrective Action/Preventive Action)

Step #6 Establish Verification Procedures

• Write SOPs
• Validate/test methods and processes
• Calibrate /qualify equipment
• Train your team

Step #7 Establish Documentation

• Where do we go for records?
• PM (facilities)
• Laboratory analyses (QC Laboratory?)
• Validation data (Validation department?)
• Engineering
• Routine monitoring (Batch record /QA review?)
• Are records complete?
• Is there a provision for the recording of all essential information?

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