GMP Problems:

The ability to find key issues in product complaints can be a tool to improving overall quality. The manufacturer must first assume responsibility for the product’s quality, and then ensure that the costumer used the product as its intended use. All complaints should be handled swiftly and in a positive manner. After review of the facts, corrective actions may need to be taken. Possible drastic actions could include adjusting a manufacturing process or even issuing a recall of a tested defective product from the market. Failing to address customer issues or implement corrective actions as needed could result in FDA warning letters and citations.

Why it’s important:

Customer complaints can serve many purposes. The primary purpose is that the costumer could have identified a possible quality or quality life issue with the product. Often, customers who file complaints are the first ones in the supply chain can identify an issue or experience a problem with the product. If swift action is taken, complaints can lead to finding root causes of problems and thus quicker solutions. If the defect product is found to be a result of malfunctioning equipment or operations, then new systems or processes can be implemented to prevent any re-occurrences. Rapidly responding to a complaint that is life threatening could prevent others from using the product and being in danger.

How to improve:

Written Procedures: The first step in handling a complaint is to have a written procedure to record facts and conversations. The record should include suggested actions to be taken and what management should review the case. Any complaints should be noted and a quick response should be provided to the customer. A step by step procedure should be implemented into the procedure and no outcomes should be ruled out, even if it means a product recall.

A complaint procedure should designate an employee with proper authority to conduct review of complaints, following the established SOPs. If needed, the designated person should have additional staff so that complaints can be dealt with swiftly and thoroughly. The reviewing personnel should have authority to view any records about the product. Commonly, complaint reviewing personnel are quality control employees. If this is not the case, quality control personnel should be notified and kept informed of complaints and investigations.

Investigation: The next step after recording all necessary facts about the complaint is to start an investigation. All investigations should be fully recorded and thorough, recording any details found into the record. Attention should be given to determine if “counterfeiting” could have been the cause. If this is not the case, investigators should consider checking other batches or batches with reprocessed products.

Distribution Records: Manufacturers must maintain proper records and information on the quantity and batch numbers of products distributed to wholesalers or customers directly. The records should include information like the names, addresses, and telephone numbers of all customers a product was sold to. In the event of a recall, having information on record will ease the process and provide quick action. These records should also reflect products given out in clinical tests or medical samples.

Follow Up: After the investigations and evaluations are complete, follow up actions should be initiated, which could include recalls of certain batches, or even entire products. Again, as with any step in this process, all actions should be documented and recorded. The complaint notification should be then annotated on batch logs and records in case there is a trend in reviews. All trends and any recurring issues should be noted and special actions should be taken to find the root cause. Often times, sound complaint handling procedures find the root cause based off of trend analysis, and thus can prevent any furthermore complaints by executing follow-up actions.

Classification of Defects: When handling complaints, it is important to clearly define the magnitude of the issues. A simple predefined classification system will aid in dealing with complaints. Here are suggested levels:

– Critical defects

– Major defects

– Other defects

Critical defects should be defined as life-threatening and require immediate review until a defect is found. Wholesalers should be contacted and alerted to start recalling the product through their distribution chains. Some critical defects include:

– Incorrect product labeling

– Counterfeit or deliberately tampered products

– Microbiological contaminations of sterile products

Major defects include issues where the consumer is at risk, but is not life-threatening. Batches will have to be recalled within a few days. Examples include:

– Labeling issues or misinformation (or lack of information) which could present hazards to the consumers

– Microbial contaminations of non-sterile products

– Non-compliance issues to specifications (e.g. active ingredient being out of specification)

Other defects include those that present minor risks to consumers. Examples of minor defect are:

-Easily visible isolated packaging/closure issues

-Contamination of packaging which may cause spoilage and where there is minimal risk to the patient.

Reasons for Recall: Any situations involving recalls should be properly categorized due to their importance. The manufacturer can then send out notifications based on the correct level of urgency, trying to not alarm consumers. Recalls can be a result of many situations, including:

– Adverse reactions reports

– Inspection results

– Customer complaints – these may be not as serious as the need to initiate a recall (i.e., evidence of a lack of sterility)

– GMP deviations/results of a failure investigation

– Requests by regulatory authorities

– Known counterfeiting or tampering instances

Summary: Complaints can be the first warning that a product could be defective and thus harmful to consumers. It is the responsibility of manufacturers to ensure they do not put consumers at risk due to quality, efficacy or inadequate products. Life-threatening complaints are considered critical defects and require immediate action. Major defects put consumers at risk, but are not life-threatening situations. These defects require recalling the batch or entire product within a few days. All recalls should be handled swiftly and positively, paying special attention to any trends in complaints.

You can find more articles like this by searching for \”InstantGMP Compliance Series\”.

Rick Soltero, President of InstantGMP designed an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Rick Soltero, President of http://www.InstantGMP.com, designed this electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed http://www.InstantGMP-Lite.com, an electronic batch record system for cGMP manufacturing. These make staying in compliance easy

Author Bio: Rick Soltero, President of InstantGMP designed an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

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