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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.
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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.
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3. Tracking the production process step-by-step
The audit trail is a log that registers any changes made in the machine by a user. Having an assessment as far as what kinds of changes is critical from a pharmaceutical standpoint. This might be the temperature for sealing the tube, the fill volume, the code you read, print, or verify. This allows the manufacturer to act accordingly if there is a risk – which is critical, because if something goes wrong you can pinpoint exactly where in the process it happened. The audit trail creates a chain of responsibility, where any changes are written into the database of the machine, such as who made the change, when it was made, what value it has, etc.
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4. Securing the operations with multi-national pharmaceuticals – and local pharma companies
Labelling is also part of the audit trail and a critical step when it comes to pharma. When you apply a label in a pharma production environment, you have a bar code on it, which you verify is correct and allows you to track the product from beginning to end. While multi-national pharmaceutical companies have been in the game for a long time, small or new players or sub-contractors would probably need to hire someone to verify installation qualifications and operational qualifications.
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5. FDA approvals – demanding the strictest standards by registering a production user-directory
CFR21-part 11 is an extension of the audit trail. In order to meet full FDA compliance you need to not just fulfil CFR21-part 11 but also meet a number of other demands, such as handling your users and local logins. In the standard setup you have local users in the operator’s interface and in order to maintain a secure environment you need to have a password. But to reach full CFR21-part 11 compliance you need to connect the machine to an active directory where you handle all the users. You also need to back up all the records to an external server, as well as have Internet timestamps. Norden is fully compliant in all of these areas.
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6. Seek help from the software experts
Product security also includes having the expertise when it comes to software. Norden follows all the major standards, such as those set out by Gamp 5, using verified PC software that runs the control system, operator interface, and the automation equipment in the machine. It’s critical that the software verifies that the machine is consistent and delivers the same result every time – and if something goes wrong that it’s handled correctly. Software verification is done Norden, and the source codes are not shared with third parties, so testing of the source code is done in-house at Norden, which ensures optimal security. When it comes to pharmaceutical product security the baseline is complying with the most stringent global standards. Norden does this by ensuring the design specifications of the machine, verifying that everything works the way it should for consistent results,