*Note* This article is NOT about Asda Cherry Soothers, or other children’s dummies being recalled. This is a post on carrying out a dummy recall/mock recall of pharmaceutical products.
If your wholesale site has not had an active recall during the course of the year, then the competent authority requires that you carry out a dummy recall/mock recall.
What is a dummy recall/mock recall?
How do you carry out a dummy recall/mock recall?
Effectively a dummy recall/mock recall is the same as a recall process which can be instigated by the licence holder, manufacturer or competent authority.
What would a good process be covering a dummy recall/mock recall?
As ever this is hard to find information. The MHRA, as the regulator, are not here to advise, merely ensure your compliance. Others talk around the subject and offer you the option to hire them.
As one of the frequent failures to comply with Good Distribution Practice, and as per our policy of “giving back” and working in the “spirit of wholesale” we want to offer a workable process for you… at no cost… in the hope that it increases quality and safety.
Our Senior Associate, Bernard Lawlor, offers his advice on how to carry out a dummy recall/mock recall.
• The new GDP Guidelines 2013/C 343/01 states that the effectiveness of the arrangements for product recall should be evaluated regularly (at least annually).
• Where no recalls occur in any 12 months, a dummy recall/mock recall must be performed.
• Person(s) performing the dummy recall/mock recall must be sufficiently trained.
• Recall operations should be capable of being initiated promptly and at any time.
• RP must be continuously contactable.
• Evidence of MHRA approval and or involvement must be obtained and retained.
• Conduct the dummy recall/mock recall as if it were real but do not cause a market scare.
• Do not contact suppliers and or customers unless simply to test the accuracy of the contact details.
• Record the duration of the dummy recall/mock recall from start to finish.
• Select a suitable product on which to perform the dummy recall/mock recall.
• Select a particular batch or batches of that product.
• Ideally, select a product that has several intakes, several sales (perhaps some returns activity) and still has stock quantities on hand.
• Using the official recall form/log, record the relevant details of the product being subjected to the dummy recall/mock recall.
• Record dummy recall/mock recall on the recall form/log.
• Complete all relevant boxes/lines on the form/log.
• Establish how many units per affected batch were purchased from the relevant supplier.
• Record findings and or process printouts.
• Establish how many units per affected batch were sold to relevant customers.
• Produce customer listing, showing sales quantities per affected batch(es), dates of sales, contact details, list of credits issued via returns. Please note, some customers may be outside of the UK.
• Record findings and or process printouts.
• Establish how many units of the affected batches are still on the premises. This may involve physically checking all stocks of that product to establish affected batches from non affected batches.
• Ensure to check the following areas for possible affected batches, stock locations, goods in, dispatch, returns, quarantine, destruction, assembly.
• Quarantine all affected stocks found (this step should be documented but not carried out in reality).
• Prepare a reconciliation to account for all affected units purchased.
• Investigate variances.
• Record the time taken to prepare this reconciliation.
• Prepare a final report for forwarding to the initiator of the recall and or the MHRA.
• If required, prepare a letter to be forwarded to relevant customers as per initiator’s instruction. Watermark with “dummy recall/mock recall do not action”. Do NOT forward this letter in case a mistaken recall is initiated.
• Inform all relevant staff.
• Prepare to quarantine all affected stocks.
• Document activities and findings as they occur.
• Critically establish the accuracy of all paperwork and records obtained.
• Utilise and involve relevant staff/persons as needed.
• The objective is to test the speed and effectiveness or otherwise of the recall system.
• Record the time taken to conduct all relevant and critical actions (actions may differ depending on the class of the recall).
• Retain evidence of all actions taken and the times.
• When complete, request the RP to close out the mock/dummy recall.
• Retain all records for at least 5 years.
Complicated? A little, but as a best-practice wholesaler you are responsible for ensuring quality and traceability of product.
Need some help or advice? We’d be glad to help.
20 Nov 2018
17 Oct 2018
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