Six steps to secure product safety in pharma filling
July 2, 2019
When it comes to pharmaceutical product security the baseline is complying with the most stringent global standards. Companies producing medical devices, over the counter products, and prescription drugs need to install and verify a consistent approach with the production process. Securing product safety in sterile pharma filling is all about repeatedly minimizing risk. Here are the six checkpoints towards securing product safety in pharma filling:
1. The supplier follows the country specific regulations
Having the correct validation process in place during pharma production ensures no end user will come to harm due to a mistake during the manufacturing of the product. As technology has advanced – particularly with the advent of automation – the rules and regulations required of the pharma industry have kept pace, becoming more and more stringent in order to ensure safety and security during production. Those rules and regulations differ from country to country, so suppliers have to ensure that the packaging machines are compliant to country-specific markets.
2. Using safe materials and evaluating the pharma production equipment
In order to comply with the various rules and regulations you first and foremost perform what is called ‘installation qualification’, which includes the selection of the correct materials for the machine, such as what is used inside the pump or inside the nozzle. Your supplier also verifies that the machine is built correctly, looking at the specifications and drawings, comparing and confirming that the machine is built for the intended purpose.
Building the machines and ensuring there is no deviance or error that could lead to some kind of harm to the product which could cause harm to the end user is key – and the initial steps with which your machine supplier is helping. Creating an audit trail is the next step, because changing any parameter in the machine is a pharmaceutical risk that could lead to unforeseen risk circumstances.
**GAMP guidance aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.