MAKE EVERY PHARMACEUTICAL MOCK RECALL BRILLIANT

CREATE AND TEST with Mock recalls!

Pharma MOCK Recall PLANNING & TESTING

World Class Mock Recall Planning & Testing Services

Pharmaceutical and Nutriceutical Recalls, Field Actions and Alerts

On average about about 4,500 drugs and devices are pulled from U.S. shelves each year. The recalled products have U.S. Food and Drug Administration (FDA) approval and in many cases, are widely ingested, injected or implanted before being recalled.

These recalls cost the pharma industry not only in financial loss but also in reputation. Most importantly, it can cause an enormous interruption to business.

It is vital for all manufacturers and distributors to be able to successfully manage recalls, with the ultimate goal of protecting consumer health and safety. The key to successful recall management is preperation, which includes assigning a team, developing a recall plan, and testing them to assure that they are kept current and are fully operational.

Mock Recalls is a company only focused on the development and testing of mock recalls. Our Mock Recalls platform is GxP compliant AND works outside your system safely and securely.

Through our robust recall platform and our partnership with RQA, Inc., a worldwide crisis management company, we offer a robust recall simulation assessment and execution solution that supports every aspect of company’s recall needs..

Schedule a 1 Hour Recall Readiness Consultation

Don’t wait until it’s too late

The combination of operational challenges and increasingly aggressive safety regulators is leading to increased product recalls and enforcement actions across all industries.

We offer valuable resources to industry at a time when efficient and effective tools and robust processes in the hands of knowledgeable people are more critical than ever.

WHY USE US FOR MOCK RECALL TRAINING AND PLANNING?

Recall Planning and Testing could include:

Procedures for acquiring data that may lead to recall action
Product identification and lot code definition, lot trace systems
Recall process flow diagram or checklists available
Resources identified to perform health hazard assessment
Elements of recall strategy defined
Model communications available: press release, customer letters
Model effectiveness checks available: written, telephone interview, personal visit Procedure for performing post-recall review

Statement of Product Quality and Safety
Procedure for maintenance of Recall Manual
Relevant regulations and regulatory authority identified
Organizational training requirements identified
Mock recall requirements identified
Recall Team members identified with contact information
Roles and responsibilities identified for team and related functions

Mock Recalls VS Recall Simulations

Conducting a mock recall twice a year is the basic assurance that inventory can be traced in the event of a recall. A recall simulation ensures that the organization is trained and ready to respond with a robust recall plan.

Mock Recalls

A mock recall typically refers to an inventory-based traceability exercise. A product is selected and the organization conducts a complete tracking of the first ship to or all products used in, depending on if a raw material/ingredient is selected or a finished product or both. There are time and accountability goals – so ideally 100% of product is accounted for withing 2 hours.

Recall Simulation

A recall simulation tests the organization’s entire process, from receipt of the information that there may be a recall issue, through investigation, regulatory contact, media prep and response, etc. The simulation includes the mock recall elements as the product is traced with the same accountability and time goals. It challenges all roles and responsibilities of the recall team, ensures the plan is up to date and acts as a training tool.

A recall simulation involves a fictitious, but realistic, situation about one of your company’s products currently in the marketplace, created to test the Recall Team’s ability to efficiently and effectively conduct all aspects of a recall. The initial report of an incident is escalated into a true crisis situation as the simulation progresses. Because it involves “real” product, information and records, a realistic situation, and is conducted under time pressure, it is as close to a “real” recall as possible.

What's the Difference?

A lot-trace exercise (mock recall) tests a company’s ability to either forward trace a component from receipt to finished product or backward trace a component of a finished product back to the supplier. This exercise tests a company’s record keeping procedures and systems as well as the internal tracking systems for components and finished goods.

A Recall Simulation includes all aspects of a “real” recall situation, and it tests people, processes and systems. One of the most important parts of a Recall Simulation is it puts the team in a situation which allows it to proactively practice its recall process and see how well it follows its plan. RQA will engage the team in complex and emotionally charged activities, such as initial issue investigation with limited information, decision making as a team of unique individuals, lot-trace exercise and root cause analysis, while sifting through an over-abundance of information and records, all under extreme time pressures.