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Head of SOLABS' Quality & Best Practices Unit - Tips for Communicating with FDA, EMA or Health Canada Auditors

Handling Customer Product Complaints

Complaints - 13 July 2016

By Brian Graeff, Head of the Quality & Best Practices Unit, SOLABS

The quality process for handling customer complaints is unique in many ways. First, it is the only quality process that interacts directly with the customer. Company representatives frequently communicate directly with pharmacists, nurses, doctors or the patients to get specific information regarding the complaint. Having an automated system that captures all the information required to understand and record the complaint is critical. Without this information, the complaint cannot be properly investigated and responded to.

The issuance of complaint acknowledgement letters, product return instructions, credit authorizations and the issuance of follow-up letters to the customer after the investigation is completed are all important activities where process automation can really help!

"The time frames for the reporting of the complaints are based on the impact on the patient. Any failure by a company to properly report complaints to the authorities in a timely fashion can lead to serious regulatory action."

Brian Graeff
Head of the Quality & Best Practices Unit, SOLABS

Certain types of complaints have to be reported to the regulatory authorities. There are specific and different reporting requirements for complaints that are associated with pharmaceutical and medical device products. The time frames for the reporting of the complaints are based on the impact on the patient. Any failure by a company to properly report complaints to the authorities in a timely fashion can lead to serious regulatory action. Here is another area where automation can help directly with compliance!

In addition to the reporting a complaint to regulatory authorities, the timely completion of the complaint investigation where the root cause and any corrective and preventive actions (CAPA) are documented are major requirements of a complaint management system. Systems that provide for the assignment of specific tasks associated with the investigation and the CAPA help assure that activities don’t fall through the cracks.

The last major capability that a complaint management system must have is the trending of complaints. Regulatory agencies expect companies to have systems that can identify for each product, for example, increases in complaint frequency, the type of complaints, categories of the root causes for the complaints, distribution data and demographic factors that may help understand the complaint and can define any actions that should be taken to prevent future complaints.

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About the Author
Brian Graeff is currently the Head of the Quality Best Practices Unit at SOLABS. Brian’s career in the pharmaceutical industry spans over 40 years during which he held various management positions in Quality Assurance, Quality Control and Production with Sterling Drug-Winthrop Laboratories, AstraZeneca and Sunovion Pharmaceuticals Inc.. Brian retired from Sunovion in 2010, where he served as the VP of Quality Operations. During his career, Brian helped manage many different drug products and APIs with the majority of his experience being with parenteral, respiratory and tablet dosage forms. Brian brings a wealth of experience in pharmaceutical manufacturing, quality management, FDA interactions and CGMP interpretation and implementation to the table.

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