Methods of pharma traceability

You might not give a lot of thought to the drugs your doctor prescribes, but you should in many cases. To monitor the quality and safety of their medications, pharmaceutical companies must implement strict systems for tracking every step taken in drug production. This process is called pharma traceability. 

Consignment Systems

Only certain drugs can be deemed “covered” and sent to a pharmacy. These drugs are consigned with the pharma company, meaning that they are being held by the drug company until they have been dispensed and verified. To ensure that these drugs have not been tampered with, a pharma company must employ several people, known as “consignees,” responsible for ensuring that each consignment is complete and on its way to the pharmacy, according to strict standards. One of the ways this is accomplished is through in-house audits. Pharmacists are responsible for ensuring that all drugs sent from the company conform to their original packaging and labeling. They may also perform random spot checks. 

Batch Serialization

Every batch of drugs manufactured by a drug company includes a unique serial number, which can trace the drug from its origin to the patient it was prescribed for. The serial number is found on the original packaging and its accompanying label. It is typical for multiple stickers placed over the title, with each layer indicating a consignment system. In addition, all products are checked by an agent who prepares a checklist of all drugs in the batch. If there is something unusual about a batch of pills, such as yellow spots, the inspector will document this information in the drug’s logbook.

Serialized Traceability

“Serialized traceability” is a system in which all products are numbered to indicate their order of packaging and batch. The serial number on each product shows the batch in which it was produced. To ensure that it is traceable back to its origin and its original packaging and labeling. It is accomplished using a process called serialization. A serial number is assigned after the pharma company packages each product. It is then applied to the product’s label and its accompanying materials.

Batch Recording

When there are multiple products in a pharma company’s inventory for a single patient, there is a need to record these products’ history. Companies employ batch recorders and feed them with data from their systems to provide this service. This data includes information about when the drugs were produced, their final packaging, and various other details that can be used to identify each drug. This data is then entered into a proprietary database maintained by the company. The company then reports its customers on any irregularities found with a particular batch of products.

A pharma company’s failure to maintain its pharma traceability (https://authena.io/pharmaceuticals/) could have disastrous consequences. As you have seen, companies have several methods at their disposal to maintain the safety of their products, and health authorities tightly regulate them. With proper oversight, pharmacists and patients can rest assured that the drugs they receive are safe and effective.