SOP for PRODUCT RECALLS 1 of 4

The Institute for Standardization and Control of Pharmaceuticals

SOP no. GQM - 052/01

The Institute for Standardization and Control of Pharmaceuticals Jerusalem

PRODUCT RECALLS
SOP no. GQM - 052/01

Name Dr. Mimi Kaplan Dr. Ori Lerman Dr. Rami Kariv Sarah Covrigaro

Position Institute Director Deputy Institute Director for Chemical Products Head of GMP Inspectorate Quality Assurance Manager

Date

Signature

UNAUTHORIZED COPY

SOP for PRODUCT RECALLS 2 of 4

The Institute for Standardization and Control of Pharmaceuticals

SOP no. GQM - 052/01

Introduction Medicinal products are recalled from the market either because of a defect in the products quality or because of a serious and unexpected adverse drug reaction. The decision to recall a drug can be taken by the manufacturer, the licensee/sponsor, the import permit holder, or the Ministry of Health. The recall may apply to a particular batch of the product or extend to a general prohibition against any use of the product in consequence of new information indicating a health risk to its consumers. The manufacturers responsible pharmacist or quality assurance manager is responsible for reporting to the Institute for Standardization & Control of Pharmaceuticals (the Institute) of a quality defect in one or more product batches of local manufacture. Information about a quality defect in a medicinal product can reach the Ministry of Health from various sources the manufacturer or licensee, the Institute, reports of an unpredicted side effect, health care professionals, or from the investigation of a complaint from the public. Speed of response to such information is of the prime importance, particularly the speed with which information in the Institute is passed to the bodies which carry out the recall. 1. Scope 1.1 This SOP sets out the chain of communications and responsibility for product recalls, the practical recall process, how a recall is to be monitored and documented and lessons learnt from it. 2. Applicable Documents 2.1 SOP for Medicinal Product Recall and/or Prohibition against Its Consumption (SOP 3, Pharmaceutical Division). 3. Responsibilities 3.1 It is the responsibility of an Institute employee who is notified of a product recall, or of circumstances which might justify a recall, to pass on that information at once to the director of the Institute and the head of the GMP Inspection Unit. 3.2 It is the duty of the head of the GMP Inspection Unit to record and document the practical handling of any recall. Definitions Not applicable 4. Methods 4.1 Notice Received by the Institute of a Product Recall or of Circumstances which might Justify a Recall 4.1.1 The Institute will receive notice of a quality defect in a medicinal product and/or of a product recall by fax or phone. It is the duty of the Institute employee who is so notified to pass on that information at once to the director of the Institute and the head of the GMP Inspection Unit.

SOP for PRODUCT RECALLS 3 of 4

The Institute for Standardization and Control of Pharmaceuticals

SOP no. GQM - 052/01

4.1.2 A team will be formed at once comprising the director of the Institute, the head of the GMP Inspection Unit and the head of either the Chemical or the Biological Product Evaluation Department, as the case may be. In the absence of any of these officials another representative of their department shall be called in. The laboratory director may also be summoned, as the Institute Director sees fit. 4.1.3 This team will decide the following next steps: 4.1.3.1 Who takes charge of the recall: a coordinator will be appointed; 4.1.3.2 Action timetable; 4.1.3.3 The speed of the response to the manufacturer according to the seriousness of the defect: level 1(life-threatening) within 3 hours; level 2 within 24 hours; level 3 within 3 working days. 4.1.3.4 Notifying the Clinical Pharmacology Department in the Ministry of Health's Pharmaceuticals Division and the relevant District Pharmacologist. 4.2 Handling a Product Recall Action will follow the Pharmaceuticals Divisions SOP for a Medicinal Product Recall and/or Prohibition against its Consumption. 4.2.1 The Coordinator shall ensure that Clinical Pharmacology Department in the Ministry of Health's Pharmaceuticals Division and the relevant District Pharmacist are notified. 4.2.2 The Coordinator, together with the recall team, shall study the information submitted by the manufacturer, check it against relevant material held by the Institute (registration files, GMP inspection reports) and held elsewhere (on internet websites), weigh whether more information needs to be submitted before a decision can be made, assess all the implications of the problem for other medicinal products from the same manufacturer and other manufacturers, examine, with the Pharmaceuticals Division, the clinical implications and the level of need in the market and, together with the Division, determine the level of risk. 4.2.3 Once a decision has been reached on how the matter is to be handled, the Coordinator shall record that decision on a Defect or Risk in Medicinal Product form, sign it, and dispatch it to the manufacturers responsible pharmacist or to the nominated pharmacist, the relevant District Pharmacist and the Pharmaceuticals Division. 4.2.4 It is most important that all written materials be sent to the manufacturer/sponsor and not make do with telephone calls. Every telephone call to the manufacturer/ sponsor should at once be confirmed in writing. 4.2.5 A time limit should be set for the manufacturer's response commensurate with the urgency of the matter. 4.2.6 The Coordinator shall tabulate the details of the recall on a computer, using the I/GMP/Recalls software.

SOP for PRODUCT RECALLS 4 of 4

The Institute for Standardization and Control of Pharmaceuticals

SOP no. GQM - 052/01

4.3 Next Steps and Follow-up 4.3.1 The Coordinator shall monitor the handling of the recall and whether the manufacturer takes the necessary measures within the time allotted him. 4.3.2 At the same time, correspondence with the manufacturer shall proceed, to whatever degree and scope required, until the investigation into the matter is complete and the required corrective measures have been assessed. 4.3.3 Insofar as the investigation requires it, contact shall be made, via the product importer, with the overseas manufacturer. 4.2.4 The recall team shall convene once a month to discuss any issues still open. 5. Documentation 5.1 The head of the GMP Inspection Unit shall collect all written and printed matter pertaining to the incident and ensure that it is properly recorded. Copies of all documents shall be sent to the relevant Assessment Unit for filing in the drug's dossier. 5.2 The head of the GMP Inspection Unit shall ensure that the dates of all meetings and the matters discussed are recorded, and these records shall be entered into the Recalls file he is in charge of. 5.3 Notification of the recall shall be sent to all the Institutes professional staff. 6. Accompanying Documents

GQM-052A/01 Example of the data table in the I/GMP/Recalls software.