Description
“Once a product is in widespread use, unforeseen problems can sometimes lead to a “Product Recall”. When an FDA-regulated product is either defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public.
Recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. But in every case, FDA’s role is to oversee a company’s strategy and assess the adequacy of the recall.”
(Source: FDA Consumer Updates)
Some of the Pharmaceutical Inspection Co-operation Scheme (PIC/S PE 009-13 Part I, 2017) guidelines for Good Manufacturing Practices (GMP) of medicinal products include:
- Clause 1.8 (x) A system is available to recall any batch of product, from sale or supply;
- Clause 8.10. There should be established written procedures, regularly checked and updated when necessary, in order to organise any recall activity.
- Clause 8.11. Recall operations should be capable of being initiated promptly and at any time.
- Clause 8.12. All Competent Authorities of all countries to which products may have been distributed should be informed promptly if products are intended to be recalled because they are, or are suspected of, being defective.
- etc
This SOP Template covers the procedures to ensure all facets of a “Product Recall”:
- There is a process map for ease of tracking a recall.
- Allows for product distributed in more than one country and involves Corporate participation.
PURPOSE OF SOP:
- To define the sequence of events and identify the relevant Company Personnel responsible for the evaluation of any potential recall situation. To present guidelines to making and enforcing the correct decision to recall stock from the market that presents as defective in quality, safety or efficacy.
- To periodically challenge the recall system by the use of an internal simulated recall exercise to ensure functionality.
