GMP, GCP & Quality Control

Biography

Biography: Nadia Narine

Abstract

Food Manufacturers must ensure every part of the receiving, production, processing and distribution processes are included as part of the trace system. Facilities have a responsibility to ensure they are able to trace all raw material and finished products. It is important that all records regardless of the form are maintained and kept accessible for any complaints, withdrawals, and recalls. Typically keeping records for the shelf life plus two years is industry best practice. Testing of the trace system should be done at a minimum of annually, and should include: primary packaging, raw materials, and finished product. A raw material from the finished lot trace can be selected for a mass balance. Traceability should be done in both directions and all supporting documentation kept. Once a mock recall or mass balance has been done, it is important that any key findings that impacted the trace are incorporated back into the management system after root cause analysis has been done. Ensuring the traceability system is robust at all times. Withdrawls and Recalls often confused and used interchangeably, they differ considerably. Withdrawal is being able to effectively contain product that has been sent to a customer and not yet reached the consumer. A recall is being able to recover all product that has entered the main stream market, and is with consumers. Withdrawals can be for food safety or quality reasons and do not have a legal setting; recalls involve government and have a legal aspect as consumers are now directly impacted.