Product classification for pharmaceutical supply companies
In order to manage quality requirements and ensure inspection security, pharmaceutical supply companies are developing identification processes for product classification.
Relevant issues include the best method of structuring and standardizing these processes and identifying the requirements of health authorities.
The detailed identification of pharmaceutical products, APIs, additives and allergenic substances can be very time-consuming and resource-intensive, if there is no standard procedure or classification manual available.
For this reason, we have compiled some hints on speeding up the information gathering process:
a) The list of ATC codes produced by WHO can be used to identify pharmaceutical products and APIs. This can be found at http://www.whocc.no/atcddd.
b) In order to identify additives, it is important to ask the customer about the purpose of the product, if the customer is a drug manufacturer or medical technology company. If the additive is required directly to manufacture products in these industries, the pharmaceutical supplier is obliged to qualify the customer. In order for the qualification process to take place, the customer must be registered with the local health authority. The relevant form for Switzerland can be found at Swissmedic.
c) There is currently no definitive list available on the internet for identifying highly active or allergenic substances. Instead the evaluation must be based on answers provided by the customer and on the customer's experience of using the substance. Assistance can be obtained from the IPCS (International Programme on Chemical Safety – Chemical Safety Information from Intergovernmental Organizations) website at http://www.inchem.org and the OECD Screening Information DataSets (SIDS) at http://www.inchem.org/pages/sids.html. In our opinion, it is too time-consuming for companies to compile and maintain the data in their own product evaluation tables.
Arcondis will be happy to provide you with support in designing classification processes for your product portfolio.