Recall Procedure

The standard requires the supplier to hold product until the required inspection and tests have been completed or necessary reports have been received and verified except when product is released under positive recall procedures. Release under positive recall procedures shall not preclude the activities outlined in 4.10.3(a). 

In continuous production, product is inspected by taking samples from the line which are then examined while the line continues producing product. In such cases you will need a means of holding product produced between sampling points until the results of the tests and inspections are available. You will also need a means of releasing product when the results indicate that the product is acceptable. So a Product Release Procedure or Held Product Procedure may be necessary. The standard implies, however, that if you have released product under positive recall procedures you do not need to hold product while in-process inspection and tests are performed. The reference to clause 4.10.3(a) is also ambiguous because the inspections and tests carried out in accordance with the quality plan or documented procedures may not cover those necessary to verify product on receipt into the plant. It would be wise to hold any product until you have... 

Complaints, product recall and emergency unblinding - complaints and recall procedures... 

For decades, FDA has worked with product manufacturers to request, and to help carry out, the recall of illegal products from the market. Courts have disagreed on whether the FD C Act authorises an injimction that includes a requirement for product recall. As a practical matter, however, the precise legal authority of FDA on this matter is irrelevant. Manufacturers routinely cooperate with FDA on the recall of any dangerous product. FDA has established detailed administrative policy governing recall procedures. ... 

Recalls are handled by the Australian Recall Coordinator within the TGA according to the voluntary Uniform Recall Procedures for... 

Consent decrees typically involve a defendant agreeing to address the areas of noncompliance in a manner satisfactory to the FDA within a certain amount of time. It can also provide for the hiring of an expert consultant to certify in detailed reports that the manufacturing facility, at periodic dates, is in full compliance with the cGMPs, and has adequate adverse-event controls, adequate training, and adequate recall procedures. It may also require the payment of money to the U.S. Treasury such as under the equitable remedy of disgorgement, as described in Figure 8. 

Give instructions regarding importance of completing medication or returning for additional doses of vaccine. Inform patients of tracking/recall procedures. 

This information is not all-inclusive. Please consult your company s QA executive, legal counsel, quality advisory team, recall procedure, or the specific regulatory requirements for handling a recall in the Code of Federal Regulations (21 CFR 7). 

Part 5 Uniform Recall Procedure for Medicines cmd Medical Devices, 1995... 

The product recall procedure depends very much on the national regulations. There should be a standard operating procedure (SOP) for storage of recalled herbal medicines in a secure segregated area, complying with the requirements specified under subsection 12.1 (Storage areas), while their fate is decided. 

Do you have a recall procedure, which enables you to recall any product effectively and promptly within 24 hours from the distribution points or market Yes No... 

Manufacturing, analytical, and distribution records and reference samples should be kept by, or be available to, the contract giver. Any records relevant to assessing the quality of a product in the event of complaints or a suspected defect must be accessible and specified in the defed/recall procedures of the contract giver. 

Recall procedures should be understood by the sponsor, investigator and monitor in addition to the person(s) responsible for recalls, as described in the guide on GMP (2, pages 28-29). 

A written procedure for product recall based upon the Australian Uniform Recall Procedure for Therapeutic Goods and the requirements of the Trade Practices Act should be developed. The procedure should specify the actions to be taken for all reasonable contingencies that may be anticipated. It should be capable of being put into operation at any time, inside or outside normal working hours and should include emergency and out of hours contacts and telephone numbers. 

The recall procedure should be shown to be practicable and operable within reasonable time (e.g. by conducting internal dummy runs ). It should be revised as necessary to take account of changes in procedures or responsible person(s). 

Drugs that have left the premises of a fabricator, packager/labeller, distributor, wholesaler and importer can be found in a variety of locations. Depending on the severity of the health risk, it may be necessary to recall a product to one level or another. Fabricators, packagers/labeliers, distributors, wholesalers and importers are expected to be able to recall to the consumer level if necessary. Additional guidance on recalls may be found in the document entitled "Product Recall Procedures". 

It should be possible to implement the recall procedure at any time, even when the concern is dosed. 

For the manufacturer Management/responsible pharmacist Dispensary Responsible pharmacist Other distribution points Responsible person or management A written recall procedure should be established. The procedures should indicate the means to execute a withdrawal for all degrees of recalls to all levels concerned, and to inform the Health Authorities, distributors, doctors, pharmacists and the public, as necessary. 

Detailed distribution records should be maintained and there should be procedures which describe the measures to be taken for stopping the use of defective radiopharmaceuticals. Recall procedures should be shown to be operable within a very short time. 

All complaints must be investigated and documented by the quality department. The recall procedure is one procedure that a manufacturer does not want to gain experience in implementing. However, when a firm finds itself in a recall situation, decisions must be made quickly and a well-defined procedure can facilitate the communication and decisionmaking processes. The procedure should identify the sources and types of information necessary for the decision, which functions are to be present in an advisory capacity, and the ultimate decision maker whether to proceed with a recall. 

Sometimes real time or complete quality control is not reasonably possible, especially when the radioactive dose is extremely high (e.g. loading of generators with mother radionuclide) or when the half-life of the radionuclide is very short. In those cases all feasible quality control tests are finalised after release, but always before administration to the patient. This two-step release requires a strict recall procedure in order to prevent administration when the delayed quality control results do not meet the requirements. 

In some situations, for example with very short-lived radiopharmaceuticals, conditional release before all QC tests are performed is necessary. As a consequence, process validation is important An immediate recall procedure must take place, when product quality is found to be insufficient Stock preparations usually undergo an extensive analytical control (see Sect. 34.9.2) and remain in quarantine until the QC is fuUy completed (see Sect. 34.9). The release is based on the assessment of the document control in combination with the analytical quality controls. During release, final reconciliation takes place. For certain preparations (e.g. aseptic preparations) also the results of monitoring of production conditions are included. 

GMP Chap. 8 Complaints and Product Recall refers, for licensed medicines, to legislation as the principle of a procedure to be followed in case of a potential defective product All complaints and other information concerning potentially defective products must be reviewed carefully according to written procedures. In order to provide for all contingencies, and in accordance with Article 117 of Directive 2001/83/EC and Article 84 of Directive 2001/82/EC, a system should be designed to recall, if necessary, promptly and effectively products known or suspected to be defective from the market. GMP is listing in Chap. 8 all actions that have to be part of a recall procedure. 

Promptly initiate product recall procedures on discovery of a product-safety issue. 

The Uniform Recall Procedure for Therapeutic Goods (URPTG) defines the action to be taken by health authorities and sponsors when therapeutic goods for human use, for reasons relating to their quality, safety and efficacy, are to be removed from supply or use, or subjected to corrective action. 

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