GMP Compliance Series: Part 8 – Product Complaints and Recalls

GMP Problems

The identification of the key issues in product complaints is a tool for overall quality improvement. The primary principle is that the manufacturer must assume responsibility for the quality of their products to ensure that they are fit for their intended use. Complaints must be handled quickly and positively and after careful review some corrective actions must be taken as necessary. This can mean amending a manufacturing process or it could mean as much as implementing a recall of a defective product from all markets where it has been distributed. Failures to address customer complaints or to implement corrective actions have resulted in FDA citations and warning letters.

InstantGMP Compliance Series-Complaints and Recalls from Richard Soltero on Vimeo.


Why a Complaint System is Important

Customer complaints serve multiple purposes. The identification of potential issues that affect the quality of the product and possibly the quality of life are very important. The customers who file complaints are normally the first ones in the supply chain who see a problem or experience the result of a problem or defect. Quick response to their complaints can determine a root cause and a potential solution. If the problem is endemic to the manufacturing operation or equipment, then process improvements can be implemented to overcome the recurrence of the issues. If the complaint is potentially life threatening, then a rapid response and a recall can prevent others from being in danger.


What Can You Do to Improve?

Written Procedures: The first step is to have a written procedure for handling complaints. It should describe the actions to be taken and the management reviews that are needed. The complaint should be acknowledged and a response provided to the customer. The procedure should include the process for considering a product recall in case there is product defect.

The basic requirements for a complaint procedure include having a designated person who has the authority to conduct complaints reviews in accordance with the SOPs. The designated person must have sufficient staff to be able to review all the complaints received in quickly and effectively. They must to be able to access all the relevant records about the product. That person may be the authorized Quality person in the organization. If not, then that Quality person must be kept informed of all complaints being investigated.

Investigation: The investigation should be thorough and fully recorded- and reflect all the details of the investigation in the records. Special attention must be given to determine whether “counterfeiting” may have been the cause. If a product defect is suspected the company should consider checking other batches, and possibly batches that contain reprocessed product.

Distribution Records: Each company must maintain records and accurate information on the quantity and batch number of any product it distributes to wholesalers or direct customers. The information should include the names, addresses and telephone numbers of all customers. These distribution records are essential to the success of any recall. This include clinical tests and medical samples

Follow Up: Once the investigation and the evaluation is completed, there should be follow up actions taken which may include a “recall” of the product, or batch. All decisions and measures taken should be recorded. The complaint should be referenced in batch records which can help identify trends during annual product reviews. Trends and recurring problems should be identified and action taken to prevent recurrence of the problems or cause. This is where the true value of a good complaints handling procedure comes in. It may be that a particular formulation or particular machine is the root cause for the complaints and the trend analysis process can point this out.

Classification of Defects: During complaints handling and especially in recall situations it is important to clearly define the magnitude of the problem. A system of classification defined by the company will be helpful. Here is one example:

  • Critical defects
  • Major defects
  • Other defects.

Critical defects are ones that can be life-threatening and require immediate action as the defect becomes apparent. In this case, wholesalers must be alerted and actions taken to start recalling the product throughout the distribution chain. Examples of critical defects are:

  • Product labelled with incorrect name
  • Counterfeit or deliberately tampered with product
  •  Microbiological contamination of a sterile product.

Major defects are those that may put the consumer at some risk, but are not life-threatening. They will require the recall of the batch or product withdrawal within a few days. Examples of major defects are:

  • Any labeling/leaflet misinformation (or lack of information) which represents a significant hazard to the patient
  • Microbial contamination of non-sterile products with some risks
  •  Non-compliance to specifications (e.g. active ingredient assay out of specification).

Other defects are those defects which present only a minor risk to the patient. Examples of such defect are:

  • Readily visible isolated packaging/closure faults
  • Contamination which may cause spoilage or dirt and where there is minimal risk to the patient

Reasons for Recall: It is important that complaints that result in potential recall situations are properly categorized. Then the company can initiate recalls with the correct level of urgency and not unduly alarm patients or the public. A recall situation can result from information entering a company in various ways:

  • Customer complaints – these may be so serious as to initiate a recall. An example could be the evidence of a lack of sterility
    GMP deviations/results of a failure investigation
  •  Request by the regulatory authorities
  • Result of an inspection
    Known counterfeiting or tampering
    Adverse reaction reported

Summary

Complaints are the first indication that a product may be defective or harmful. Manufacturers are responsibility for making sure their products do not place the consumer at risk because of inadequate safety, quality or efficacy. Critical defects can be life-threatening and require immediate action as soon as the defect becomes apparent. Major defects are those that may put the consumer at some risk, but are not life-threatening. They will require the recall of the batch or product withdrawal within a few days. Recalls must be handled positively and carefully be effective in removing defective product from everywhere where it has been distributed. With the solutions offered by InstantGMP™, pinpointing the cause of a recall occurrence and preventing it from happening again is part of our mission statement.

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