The staff at InstantGMP prepared the GMP for Dietary Supplements Compliance Series of presentations to focus on good manufacturing practices and GMP compliance for dietary supplements manufacturing. These are brought to you by our quality and manufacturing experts in the hope that it will help you avoid any GMP compliance issues in your shop. This presentation will address the GMP procedures for complaints and recalls.
The identification of the key issues in product complains 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.
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.
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.
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
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.
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 consumerat 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 labelling/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.
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
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.
This presentation is just one of many articles and videos available on cGMP compliance for Dietary Supplements. You can find the rest at the Resource Center at www.InstantGMP.com.
InstantGMP Compliance Series - Complaints and Recalls
InstantGMP Compliance Seriesfor cGMP Dietary Supplements Complaints and Recalls
Complaints and Recalls• Identifying key issues in product complaints is a tool for quality improvement• Primary Principle: Complaints and information concerning potentially defective products must be carefully reviewed and corrective action taken Electronic cGMP Manufacturing Execution System
Procedure• Written procedure (SOP): – Describes action to be taken – Includes need to consider a recall (e.g. possible product defect)• Designated responsible person: – To handle complaint – Decide on measure to be taken – Has sufficient support staff – Has access to records Electronic cGMP Manufacturing Execution System
Investigation• Thorough investigation: – QC involved – With special attention to establish whether "counterfeiting" may have been the cause – Fully recorded investigation – reflect all the details• Depending on product defect (discovered or suspected) – Consider checking other batches – Consider batches containing reprocessed product Electronic cGMP Manufacturing Execution System
Distribution Records• Available to authorized person and contain sufficient information on: – Wholesalers – Direct customers – Export locations – Batch numbers and quantities – Including for clinical tests and medical samples• Permit effective recalls Electronic cGMP Manufacturing Execution System
Follow Up• Investigation and evaluation should result in appropriate follow-up actions – May include a "recall"• All decisions and measures taken should be recorded• Referenced in batch records• Records reviewed - trends and recurring problems Electronic cGMP Manufacturing Execution System
Classification of Defects• If complaint is justified, then there has been a failure of the quality system• Once defect has been identified, company should be dealing with it in an appropriate way, even recall• The definition of defects is useful, e.g. – Critical defects – Major defects – Other defects Electronic cGMP Manufacturing Execution System
Critical Defects• Those defects which can be life-threatening and require the company to take immediate action• Examples – Product labelled with incorrect name or incorrect strength – Counterfeit or deliberately tampered-with product – Microbiological contamination of a sterile product Electronic cGMP Manufacturing Execution System
Major Defects• Defects which may put the consumerat some risk but are not life-threatening and will require the batch recall or product withdrawal within a few days• Examples – Any labelling/leaflet misinformation (or lack of information) which represents a significant hazard to the patient – Microbial contamination of non-sterile products with some risk for patients – Non-compliance to specifications Electronic cGMP Manufacturing Execution System
Other Defects• Those defects which present only a minor risk to the consumer— batch recall or product withdrawal would normally be initiated within a few days• Examples – Readily visible isolated packaging/closure faults – Contamination which may cause spoilage or dirt and where there is minimal risk to the patient Electronic cGMP Manufacturing Execution System
Reasons for Recall• Customer complaint• Detection of GMP failure after release• Request by the national authorities• Result of an inspection• Known counterfeiting or tampering• Adverse reaction reporting Electronic cGMP Manufacturing Execution System
Summary• Complaints may lead to defective product• Manufacturers are responsible for assuring the consumers at not at risk• Critical defects can be life-threatening and require immediate action• Major defects may put the consumer at some risk, but are not life-threatening• Recalls must be handled positively and carefully reviewed to be effective Electronic cGMP Manufacturing Execution System
InstantGMP™Find more presentations on cGMP Compliance for Dietary Supplements in the Resource Center at www.instantgmp.com