How do you handle GMP quality complaints?

GMP must be a culture in the Organization Is mandatory develop habits in the production flor as well as across entire Supply Chain . Quality is a business partner to develop Thai cultural change that can impact the growth and performance of the Business.Organizations that present resignation to GMP Culture will pay a high price in Cost, Quality , Service and People . GMP always !!

The very first step to overcome GMP complaints is by identifying the error,defect value ,risk factors and risk posing to the consumers.the quality complaint be dealt or handle with care that no such step is left that still can risk even a minute amount to the consumer. the risk at very first be finished and products be marketed unless and untill it is free of any risk.and fully comply to the GMP,ISO,USP several standards

The way we handle GMP Quality Complaints, from a formulation point of view is: * First ensure the manufacturer has a GMP SOP or protocol in place that can be followed and checked off. This must sit with a specific team, usually a Quality Control Department. * The complaint must go to the QC Department or the person responsible in the department. * Usually, the complainant is contacted to fill in the required details of the complaint and submit any photos or samples of the item in question. *A process by way of identifying the cause of the complaint must be established.

When receiving a complaint, it can come from many sources. Directly from a patient, from a healthcare professional, or even from an employee whose overhead a conversation about a product made by their employer. The first thing to remember is that the initial contact with the complainant is handled correctly. The complainant will typically provide all the details in relation to how it has affected them but the person receiving the complaint must ensure that essential information is not missed. The process must be documented and information gathering recorded the same way each time. Vital details such as product name, batch number, purchase date, storage conditions, complainant contact details are needed.

It is important to always request samples of defective units from the customer. Verification of defective samples is crucial in finding the correct (not "most likely") cause of the issue. Request the customer to not modify/change the samples in any way and send them in "as found" state as much as possible. For most regulatory agencies, i.e. FDA/ Health Canada, the verification of retain samples from the same batch is an expected "must". Also think about the risk and immediate actions - if the complaint presents a potentially high risk, what do you do with the product already in inventory or the batches in production? In some cases, putting the inventory ON HOLD until further notice is critical so that the defective product isn’t shipped out

CAPA، Corrective Action and Preventive Action Root cause Identification Brainstorming Meeting FMEA 8D Action Plan Doing Effectiveness of CAPA Closed the Compliant

while investigating the root cause analysis of any deviation or Market or comsumer complaint or any voilation of GMP.every step be thoroughly checked and pre written.a written evidence be kept for removing deviation.

It is also important to ensure the issue, if warranted by severity or occurrence is contained. Investigations shall include checking whether the same issue is present in the rest of the batch, other batches and whether it affects all product. Depending on severity, product recall must be considered when end user risk is high.

We must also conduct an impact assessment and ensure our root cause analysis and resulting CAPAs extend to all potentially impacted batches and products.

It is important to not stop at "User Error" as your root cause. The next step is "Why did the customer incorrectly use the product?" For example, the actual root cause could be misleading or difficult to read instructions. Understanding why the cusotmer use the product incorrectly could lead your organization to design or equipment issue that you would not catch during manufacturing and product testing.

1. Find out 'what is wrong?' Not 'who is wrong'... otherwise the fear will force to hide the facts 2. Action, communication is not enough...the true process improvement and system development align to customer focus are not only commitment but the enjoyment resolving the problem is the journey towards excellence. 3. The complaint trigger to change the mindset and so accepting it as a source of R&D. Not repeating complaint but the new type of complaint is good for innovation beyond the customer's expectations.

Also in the food industry as this is my area of expertise. I would ensure all documentation is available to all auditors for their information in a clear and consise way. This will show that you are transparent with your procedures and effectively deal with complaints in a professional manner which would impress an auditor and mean they will have great respect for your company and lead to contracts with their respective companies being renewed and show the management commitment to food safety.

once corrective and preventive actions had been taken and the deviation had been removed and amended properly.all the steps taken for should be written and be documented with proper file history. and such things with documented proof be advertised on websites of the company,social media account etc.

Appreciation for the customer who raised the complaint is most important, as the customer who raised the complaint has a level of loyalty; a non-loyal customer will never raise a complaint. 

The quality complaints may trigger the recall of the concerned batches/lots from multiple sites, including hospitals, distributors, and CROs where the preclinical and/or clinical studies are being performed.

quality is not a step at the end.its the very first step till end of consuming.quality is a day to day event.and there is no end to quality.how much quality our mind think can be bring into reality

Tracking and trending of non-quality complaints such as inquiries can provide insight to many departments outside of the direct quality unit. This information may assist additional departments in tasks such as assessing product availability and considerations for new dosage or packaging configurations.

The data you collect from your complaint handling process needs to be reviewed by your organization on a regular basis. It will help you not only with your CAPA effectiveness but also your product development thus creating first in class products.