03/07/2019 Regulatory Requirements for Market Complaints : Pharmaceutical Guidelines

Regulatory Requirements for Market Complaints

Know the regulatory guidance on market complaints of pharmaceutical products.
The process of manufacturing is characterized by a number of steps, checks, tests, audits as well as evaluations along with other elements of quality
like validations and many others. All these components give confidence to the process or system that it is functioning as expected. While all these
elements are critical, the final hurdle is to make sure that the product is successfully manufactured with expected quality.

However, market complaints are almost unavoidable. Customers may claim that the product doesn't smell right, or even say that there are parts of
insects inside the bottle at the time of packaging and so on.

Basically, consumers complain about a lot of things. Market complaints are considered as communications pertaining to a perceived or a real
defect in the pharmaceutical product or even, the failure of a product to meet consumer expectations.

Typically, complaints might originate from different aspects of the product such as the services, delivery of the product, quality, communication and
response time, billing, documentation and follow up. An effective complaint handling system provides the company with an opportunity to enhance
the quality of its products. It is a perfect tool for ensuring compliance with good manufacturing practices.

Apparently, there is a regulatory guidance on pharmaceutical customer complaint management. Below are the cGMP expectations of pharmaceutical
market complaints.

1. There should be a clearly defined system for collecting complaint related information. The roles and responsibilities, as well as the process related
to the complaints, should be understood by all the relevant personnel. Besides, the individuals responsible for gathering information from the patients
and consumers must ensure timely and consistent collection of the same.

2. Investigations should be performed to establish the significance of the market complaints, the cause, as well as the potential effects of the defect
or the supposed quality issue of the product. Of utmost importance is to ensure that the investigations are taken seriously.

3. The records of the complaint, the process of investigation and the results should be recorded. These records should give the evidence of an
action, event or decision. The auditors and inspectors are usually highly interested in reviewing the complaint files. The files need to be not only
complete but also updated at all times. It is okay for an investigation to be kept open for some time when a complaint sample is being awaited by the
consumer.

4. The investigation conducted should extend to other pharmaceutical products that could possibly be impacted. The regulatory authorities always
want to know that all potentially impacted pharmaceutical products are part of the investigation.

5. Solutions should be taken in order to reduce the risk that consumers could suffer. A firm should make use of quality risk assessment tools to define
the potential harm to patients as well as the likelihood of its occurrence.

6. The data from the complaints should not only be monitored but also communicated and then utilized for improvement purposes. This information
should also be communicated to the relevant regulatory authorities.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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