Post Operational Activities
By: Shamita Kohli, Supriya Sharma
Poona College of Pharmacy, Bharati Vidyapeeth University, Pune
Pharmaceutical manufacturing & distribution starts with getting feed back as to what a customer wants. This will leads to developing & manufacturing & distributing of desired product to the customer. When customer receives & uses the product he may give good feed back or he may give adverse feed back. Manufacturers must use this feed back to improve products & eliminate deficiencies.
If the product has shown same defects the manufacturer recalls the product, handles the returned product appropriately & either salvage or destroy it.
Post operational activities includes distribution of finished products, recalled products, returned products, complaints & adverse effect & drug product salvaging.
Product is distributed either for sale or samples to doctors. A detailed record of its distribution should be maintained up to the wholesales. Finished products should be held in quarantine until final release & after that, should be stored as usable stock. Records of evaluation should be available with manufacturers.
Recalled products: Distributed product may get recalled for various reasons e.g. if the product is substandard quality. Stability related problems, accidental damage during transportation. A detailed SOP/R should be there for product recall. A person should be designated for execution of recall supported by staff. Recalled product should be stored in separate secure area. A final report should be prepared on reconciliation between distributed & recovered products.
Returned: Distributed products can be returned for substandard quality, damaged packaging, stability issues etc. Such products should be stored securely & should be destroyed unless modified to a satisfactory quality state. Such products should be assessed by quality control & then considered for resale & relabelling. A detailed SOP should be available for handling of returned products. Records of returned product should include name & label potency of product, reason of return, quality returned, date of disposition etc.
Complaints & adverse effects: A product complaints should be used for improving the product quality. there should be detailed SOP/R for complaint handling. A person should be designated for complaint handling with sufficient staff. All decisions & actions taken should be recorded & a file should be maintained for such products & shall be maintained for one year after expiry date of the product. The record should mention name & strength of product, batch no., name of complainant, nature of complaint, investigation made, if not made, reason for it is not investigated.
Adverse events: There should be a system for dealing with adverse events. A detailed SOP/r should be available indicating the responsible person with appropriate knowledge & experience. He will investigate the events & will take necessary actions.
Salvaging: Sometimes batches of finished product which are either stored in company’s ware house or in market place are required to be salvaged. SOP/R for salvaging should exist. Finished products which have been subjected to improper storage conditions shall not be salvaged. Salvaging must be done if lab tests & assays indicate that drug product meets all applicable standards of identity, strength, quality & purity. Records must be maintained for salvaging.
Current Good Manufacturing Practices 
unlike the introductory paragraph, where the customer feedback is represented as optional/subjective activity,
i believe that feedback is mandatory [as a post marketing activity]; required not only for adverse event but also for continuous improvement; more so for the pharmaceutical industry.
one can add many significant systems such as ‘annual product review’, change control and deviation review…etc., These systems are not just regulatory requirements but have to be looked in for objective evaluation and feedforward mechanism.
valiveti
July 3, 2008