PART III FINISHED PRODUCT QUALITY CONTROL
In the concluding part of our series on Quality Control, we present a summary on finished product quality. Input for this series was provided by K. Sivaprakash, Vice President -Technical and S. Velmurugan, Manager, QC/QA.
Finished product quality control starts with sampling of containers. Sampling is carried out at defined locations, using procedures designed to prevent contamination of the product. Every container of finished product is sampled irrespective of the number of containers. Before sampling, all the containers are labeled with in-process temporary tags that list product name, lot number and batch quantity. Sampled containers are marked to indicate that they have been sampled. Samples are physically examined for variations if any, when compared with previously accepted lots. A composite sample is analyzed as per the product specifications, for all parameters including microbial analysis. The container once sampled is immediately packed and sealed.
If any of the samples show variation or deviation in product quality , the containers are quarantined with appropriate label and stored in a designated area.
Once the product passes all tests with respect to the predetermined specifications, the containers are labeled with new finished product labels. These labels contain the following information - Product name, Lot Number. Net weight., Tare weight of the containers and Manufacturing and Expiration dates of the product. The in-process tags are then removed.
The material is now ready for shipping. Before shipping , QA personnel again inspect the labels for accuracy, and confirm that the containers are clean and sealed properly. A detailed Technical Report is generated for every product and a specific number .(Analytical Reference #.) is allotted to each and every batch to facilitate traceability.
A predetermined quantity of retain sample is stored in a designated area. The retain sample is destroyed 12 months after the expiration date of the product. All recorded documents are maintained on file until the end of the product's shelf life. These records are destroyed after one year from the expiration date.
The materials are now ready for shipping and moved to a designated "finished product - approved" area.
