Risk Management for Bio-Pharma ICH Q8 and ICH Q9

ICH Q9 elements of risk management

Risk Identification -> Risk Assessment ->Risk Mitigation -> Risk Communication

How to identify risk

•Theoretical analysis
-Science, engineering, or math
•Based on experiments
-Structured or unstructured experiments
-Edge of failure or validation
•Statistically derived
-Trend analysis

FMEA and HACCP

FMEA salient features

•How can the process fail?
-Power outage stops mixing
-Wrong valve open sends product to drain
•How can each mode be made less likely to occur, and less harmful if it does occur?
-Back-up power, UPS
-Feedback or automation control

ICH Q8 design space

Risk AssessMent

Risk can be reduced by

•Risk mitigation—two strategies
•Reduce the severity (building codes for earthquake resistance; testing)
•Reduce the probability (stop sign at intersection of two roads; training)

HACCP concepts for Food processors

The 7 principles applied to HACCP are
- Conduct a Hazard analysis
-Establish CCPs
-Establish critial limits
-Establish a monitoring system
-Establish corrective action
-Verification
-Record keeping

5 prelim steps to support the HACCP model
- Create the HACCP team
-Describe the products
-Identify the final users
-Create a flowchart of production process
-Verify the flow chart

Building requirements for a Food Audit

Building and Grounds should have -
-Lights clean and protected
-Glass, metal and brittle plastic control
-Wooden items eliminated
-Adequate lighting in production and storage areas
-Floor surfaces clean no water, good condition
-Doors pest proof
-Dock doors have buffers
- Walls in good repair no entry points for pests or harborage
-Personal item storage
-18 inch perimeter and 14 inches between rows
-Outside areas clean no standing water or weeds, litter
-Pallet storage clean and adequate
-Pallets maintained broken pallets removed
-Dumpster/cull area clean, covered
-Backflow prevention
-floor drains adequate

Third party audit in food facility

The difference between Regulatory and third party audit is at one side regulatory audits are concerned with compliance with code but thrird party audits go beyond codes and evalute the management of food safety systems. A facility can fail in third party audit though it is in compliance with regulatory requirements.
Here are list of general food safety requirements which is must for third party audits.

- GMP signeage is present in key locations
-Production and storage areas should be free from pests and any areas 20ft around it should be free from recurring pests.
-Pest control equipments are located away from infected area and monitered every month
-Pest control equipments should have barcodes.
-Ingreditents and products should be packaged and care to be taken to avoid cross contamination
-Storage racks should allow free passage of air
-On hold products should be segregated and properly identified
-Ingredietnts , products and packaging should be rotated in FIFO
-Equipments designed to prevenet condensation, dust or spillage
- Complete enclosure of packaging and processing areas.
-Raw ingredients should be examined before usage
-Unit and carton packaging should be coded for production day
- Bathrooms adequate in number, design and number, and stocked
-Hand washing stations adequate in number, design and number and stocked
-Warm water available for hand washing
- Single service containers not re used for food
-Reusable containers marked for purpose
-Infected employees are restricted or excluded, wounds bandaged
- Hair nets, beard nets, restraints
-Jewelry confined to a wedding band
-Clean outer garments
-Smoking, eating, drinking controlled
- No items in upper pockets
- No equipment should have provisional repairs using tape, cardboard, string, wire
-Temporary repairs should have date stamps.
- Equipment cleaning should have - Surfaces cleanable ,Clean items used for storage ,Protection of food during cleaning ,Cooler coils, fan guards clean ,Stored equipment protected , Safety equipment for sanitation crew ,Cleaning equipment color coded or identified for use ,Excess lubricants removed

Food Recall - Each Teams responsibility

There are many steps in each recall where multiple teams are involved and hence it is very important that each team exactly knows what to do and when to do. Here is a snap shot of all teams involved and at what stpe what need to be done.

Notification of a recall
Sales and Quality Team - These 2 teams generally receive the call

Initial risk assessment - Quality team does the initial risk assessment

Assembling recall team - The admin dept assembles all people who should be involved in the recall process.

Information gathering - Following teams are involved in this step
- Admin - Coordinate all team
- Production -Review ingredient lot numbers used. Check production records.
- Warehouse - Track ingredients and finished products. Check for rework, damaged goods.
- Quality - Check micro and lab results.
- Maintenance - Review all Work Orders, repairs during problem period
- HR - Check for staffing issues and levels.
- Legal - Contact insurance. Work with PR.
- PR - Develop communication plan
- Sales - Ensure customer contact info correct. Finalize customer notice with Legal.
Notification to CFIA
- Admin and Quality team generally calls and informs the authorities
- Legal - team reviews the wording of communication
- PR develops the initial communication to customers.
Customer Notification
- Admin team's duty is to ensure all teams has resources.
- HR works with PR to communicate the staff
- Legal team deals with contacts by consumers, customers and lawyers.
- PR team communicates with public, shareholders and staff.
- Sales team Faxes and calls to customers.

Product Retrieval and storage
- Warehouse team arranges for trucking. Calculates % product retrieved.Secure the goods in - - warehouse (class 3) or in locked trucks (class 1&2)
- Sales team co-ordinates with warehouse.

Investigate the problem
- Warehouse gets the sample of product.
- Quality team analyzes and Gather data
Dispose of product
Warehouse ensures products are destroyed or hire third party.

Food Recall steps and recall plan components

Steps of food recall
Notification of camplaint --->Initial risk assessment ----> Assemble recall team -->Gathering of information --> Determine risk level ---> Regulatory body communication --->customer notification --->Retrieve products --->Store faulty products --->Investigate the root cause -->Dispose the product

Recall team comprise of
-Plant Manager
-Production manager
-Quality manager
- Warehouse manager
-Sales Manager
-Human Resource
- PR, Legal and consultants
Components of a Recall Plan
The manual should include
-Responsibility of the tracebility co-ordinator and all teams
-Customer notification procedure
-Contact list details about all regulatory and gov people
-Description of product code identification
-How to handle product return
-Classification of Hazard level
-How to track customer complaint
-Description of test method used for traceability
-Maintenance of customer records
But you should create a Mock recall and prepare your teams for the actual recall.