Per FDA guidelines and GMP requirements, medical product manufacturers must have a formal program in place for the handling of Product Complaints. Products that are ultimately distributed to the end-user are subject to a wide variety of complaints that the manufacturer is required to track, investigate, and maintain diligent records for. In many instances, the complaints tend to be specific to product package or container shipment. A damaged carton, a deformed container, a broken vial or bottle, a cracked closure system are some common examples. In other instances, damage to the held drug product may also occur. A shortage or overfill of the product volume, damaged or broken tablets or capsules, a malfunctioning syringe system are some examples.
Th CS Analytical Team has many years of experience developing, implementing, managing and executing Product Complaint and Retain Sample programs that are tailored to the client’s specific needs or circumstances. Common features of an effective Product Complaint / Retain Sample Program include:
- Ability to receive product complaint samples from numerous locations.
- Fast (typically 72 hour) inspection and issue of a quality system reviewed report of analysis to include digital images.
- Comprehensive record management of all product complaints samples received.
- Dedicated and secured client storage space of all retain samples. Multiple storage conditions available to include monitored room temperature, cold and sub-cold conditions as well as client custom conditions for temp & RH.
- CS Analytical will be responsible for management of product disposal at the expiration of assigned storage time.
- There will be no minimum number of samples per month requirement.
- In most cases, laboratory fees are based upon a per sample charge preventing the client from making a large commitment.
- All work will be performed in the CS Analytical, FDA regulated, cGMP facility located in Clifton, New Jersey