Validation & traceability for packaging machines: IQ/OQ/PQ, risk analysis, and certificates for materials, welding and calibration.
Quality might be an ambiguous concept if you cannot prove it while comparing it to clearly defined standards. In Universal Pack we take quality very seriously and never get exhausted of giving evidence of it. Our packaging machines are built from scratch with prime quality materials and complete with state of the art technology. We uniquely code every single component, keep full track of it and provide documentation certifying its compliance with Pharmaceutical industry regulations.
Get to know our comprehensive range of certificates to grasp what prime quality means to us.
What documentation can we provide you?
An essential list ready for you includes for instance: certificates of all materials and parts in contact with the product, welding certificates, calibration certificates and parts full traceability.
The provision goes beyond the latter certificates for proving the components quality and compliance, as it stretches to further documents concerning the line construction and effectiveness.
The list goes on with:
- IQ (Installation qualification)
- OQ (Operational qualification)
- PQ (Performance qualification)
- FDS (Functional design specifics)
- HDS (Hardware design specifics)
- Risk analysis
FDA Regulations
FDA regulations are the legally binding rules issued by the U.S. Food and Drug Administration (FDA) that set requirements for how certain products are made, tested, labeled, packaged, stored, and marketed in the United States.
They mainly apply to:
- Drugs
- Medical devices
- Food & beverages
- Dietary supplements
- Cosmetics
In packaging terms, FDA rules can affect things like:
- Label content
- Safety features
- Material suitability
- Good Manufacturing Practices (GMP) expectations around hygiene, traceability, and quality controls
As fundamental parts of the safety measures in the pharmaceutical industry, security systems to govern access and recorded data on the production line can also be provided. They can manage different levels of access (e.g. operator, factory, administration) making the machinery compliant with CFR 21 part 11 regulation.
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