SOP

1. Objective
To lay down a procedure for product recall.

2. Scope
This procedure applies to the recall of a batch or batches of any product for which the company is licence holder, authorised distributor or importer

3. Responsibility
Quality assurance, Pharmacovigilance and Warehouse Department

4. Procedure 
4.1 Product and batch recalls are normally carried out for safety, precautionary or legal reasons. A potential product defect may be identified by or notified to the company by one of the following means:
4.1.1 The quality issues system including deviation, OOSs, OOTs: including the situation when the impact on other or already released batches is considered.
4.1.2 Product quality reviews
4.1.3 The customer complaints and returns process.
4.1.4 The processing of adverse reactions and other safety information procedure.
4.1.5 Communication from the Regulatory Authority, or other regulatory authority.
4.1.6 An internal document review.
4.1.7 Product testing (e.g. stability testing).
4.1.8 Notification by field-based personnel.
4.1.9 Notification by the manufacturer or MA holder.

4.2 Any member of staff receiving information relating to a potential product problem must immediately pass full details to the company’s designated person, who shall in turn inform the designated person responsible for handling product complaints. All information should be provided within less than 8 hours of notice, immediately and with no delays. The route of communication may be direct, by telephone or email.

4.3 As soon as the potential product problem is reported, immediate action must be taken to investigate it and to identify its scope and seriousness (immediate action to be taken within less than 8 hours of receipt). Investigations into the product batch should be performed and may include:
4.3.1 Review the clear requirements as documented in the quality agreements where company is not the marketing authorisation holder.
4.3.2 Samples availability and or retention samples available from the impacted batch for internal review.
4.3.3 Communications with contractors and customers.
4.3.4 Laboratory analysis of the product.
4.3.5 Review of product / batch documentation.
4.4 All product defects must be classified according to the nature of the fault and the potential risk that it may present to the user. The appropriate classification must be discussed with the Defective Medicines Reporting Centre (DMRC). The standard European classification is used in both the UK and any other countries where the product was dispatched:
Class 1: the defect is potentially life-threatening or presents a serious risk to health;
Class 2: the defect may cause illness or mistreatment but is not life-threatening or serious;
Class 3: the defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons, such as non-compliance with the marketing authorization or specification;
‘Caution in Use Notice’ (also called a Class 4 Drug Alert in the UK): there is no threat to patients and the defect is not likely to impair product use or efficacy (e.g. minor defects in packaging or other printed materials).

4.5 Notes and minutes of meeting must be kept of all meetings, discussions and investigations regarding the potential recall.

4.6 The decision to recall a batch is made in consultation with the regulatory authority balancing the risk to patient coming from both the defective product and the lack of it on the market/supply chain.

4.7 Designated person must immediately (not more than 24 Hours from when the recall decision is made) notify in writing the contract company responsible for storage and distribution of the product concerned (hereinafter ‘the Distributor’) upon the final decision on recall as made in consultation with the regulatory authority. This notification must make clear the name, pharmaceutical form, strength and batch number(s) of the product and the reason for the recall. All stocks of the product or batch must be placed immediately into quarantine status and no further stocks should be despatched. The extent of the intended recall as proposed by company and agreed with the DMRC and/or the local authority in the country where the batches has been distributed will also be communicated at this stage.

4.8 Depending on which party in the drug product supply chain instigates the recall all the upstream and downstream parties affected by the recall will me immediately notified of the decision (no later than 24 hours from when the decision to recall a batch was made) e.g. API supplier, starting materials supplier, drug product manufacturer, drug product packager.

4.9 The recall responsibilities are shared as part of the quality agreements with the relevant parties involved in the supply chain and the implementation of the recall requirements is reviewed periodically and overseen by company during periodic mock up recalls and periodic GMP site audits.

4.10 The DMRC and / or local regulatory agency will be also informed immediately (not more than 24 Hours from when the internal recall decision is made), and consulted on the final decision to recall, unless they were responsible for instigating the recall. The minimum information to be given to the DMRC and / or local regulatory agency should be the brand and/or generic name of the product, the manufacturer, the strength and dosage form of the product, the product licence number, the batch number or numbers, the expiry date or dates, the nature of the defect and an account of any action taken in consequence. The final decision on recall lies with the regulatory authority.

4.11 The company’s designated person for parmacovigilance should also be consulted on the need for/notified of all recalls, irrespective of whether a safety issue is the cause.

4.12 The distributor must have in place a system to identify all recipients of the batch(es) concerned and must immediately use it to prepare a list of all customers that have to be contacted in direct connection with the extent of recall as communicated by company (e.g. wholesalers, pharmacies and hospitals, end user level).

4.13 Designated person shall provide the distributor with a written statement to be sent by the distributor to all customers to whom the batch or product has been supplied. This will usually include a brief explanation of the reason for the recall and must accurately reflect the seriousness of problem. Such communications must normally be approved by the DMRC in the UK and local regulatory agencies in other countries where the product was dispatched.

4.14 The distributor shall contact all relevant customers, usually by letter, telephone or facsimile, and shall arrange for collection of any remaining stocks at customers’ premises.

4.15 All recalled packs must be placed in quarantine status by the distributor until their fate has been decided.

4.16 If deemed appropriate after consultation with the DMRC and/or local regulatory agency where the product was dispatched, the QP/MA Holder and designated person, with the assistance of the company’s consultant medical adviser and / or Pharmacovigilance (PV) consultant if appropriate, shall prepare a press release for submission to the pharmaceutical press, including the pharmaceutical journal, chemist & druggist and hospital pharmacist. This document should include details of the batch(es) or product concerned, a brief reason for the recall and advice to pharmacists concerning the return of the batch or product concerned.

4.17 In the event that a recall is instigated because of a safety concern, consideration should be given to wider publicity of the recall. This shall be at the discretion of the designated person, the medical adviser, with the advice of the DMRC.

4.18 The fate of recalled goods shall be decided by the designated person.

4.19 Full records of recalls related to a safety issue must be made and kept indefinitely. Full records of all other recalls must be made and kept for at least seven years.

4.20 The aim of any recall is to reconcile completely the stock released and distributed with the stock received back, however this can seldom be achieved 100%. It is therefore up to the designated person to decide when the recall is complete. Firm guidance cannot be provided but may either be percentage based e.g. 90% reconciled or time based e.g. no further returns received after 14 days of notification. All recall records should be made available to the DMRC and/or local regulatory agency on request.

4.21 All reconciliation records should be signed by the designated person and should be stored in the recall file, these include and are not limited to recalls of batch distribution, and relevant reconciliation and release records within the supply chain including the manufacturing site or depending on the scope and extent of the recall, the starting materials site.

4.22 A summary report of any recall should be documented and sent to the DMRC and/or local regulatory agency to notify the completion of the recall.

4.23 The destruction certificate should also be filed with the recall file when destruction of the recalled batch has been completed.

4.24 Any storage and distribution, inventory records and reconciliation reports should also be filed in the recall file.

4.25 A “dummy/mock-recall” shall be carried out annually, unless a genuine recall has occurred. This will be instigated by the quality assurance department who will select a single product and batch at random.

5. Abbreviations:
SOP: Standard operating procedure
OOS: Out of specification
OOT: Out of trend
MA: Marketing authorisation
DMRC: Defective medicine reporting centre
UK: United Kingdom
GMP: Good manufacturing practices
QP: Qualified person

6. References:
6.1 Council Directive 2001/83/EC of 6 November 2001: articles 76 – 85 on the wholesale distribution of medicinal products for human use as amended in particular by Directive 2004/27/EC.
6.2 Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007.
6.3 Batch Recall of Pharmaceutical Products. Second Edition, September 1994. The Association of the British Pharmaceutical Industry.
6.4 A Guide to Defective Medicinal Products (MHRA).

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