Regulatory factors to consider before purchasing a vial labelling machine
Among the top considerations when selecting a vial labelling machine for use in a pharmaceutical manufacturing environment is how well it supports overall regulatory compliance.
Beyond considerations around capacity, quality, delivery and price, this aspect of a machine purchase is probably the most significant selection factor beyond overall labelling performance and operating reliability.
Seek solutions intended for pharma applications
Pharma’s equipment buyer’s require more assurances to implement new equipment into their production processes.
A lot of regulatory expectations have to be met before a new piece of equipment is qualified, commissioned and put into production in a pharma Current Good Manufacturing Practice (cGMP) environment.
Equipment qualification and validation
Equipment qualification and validation is a basic authority requirements for equipment in the pharmaceutical and medical business. For being in compliance you will need to start with a Quality Activity Plan followed by Validation Master Plan (VMP) and flow through a series of documents that define the scope and tasks required to successfully execute equipment qualification. You will receive a note of deficiency if you don't follows the authorities and legislation requirements and expectations to the mandatory validation documents starting with the Validation Master Plan.
To guide the process, the VMP defines the roles and responsibilities of the people involved in equipment qualification and directs compliance strategy. Included in this is the Equipment Validation Plan (VP) which may include more than one piece of equipment.
The list of equipment is appended to the plan. Each piece of equipment must have its own stream of documentation; this includes:
- User Requirement Specifications
- Design Qualifications
- Risk Assessment
- Installation Qualifications
- Operational Qualifications incl. Process Validation
- Performance Qualifications
Be sure equipment is validation and audit ready
Regardless of the vendor, be sure that the vial labelling machine you select is documented for pharmaceutical application.
All of this documentation is necessary to commission equipment. Purchasing equipment from a labelling solutions provider without it is no solution - especially to pharma.
Although large pharma companies may have staff to support extensive equipment documentation to manage compliant equipment acquisition, a smaller company may not have the same resources to navigate machine commissioning without support.
That’s why vendor selection may be the most important factor to consider in making a labelling solution purchase decision. Those with specific experience and the expertise to know exactly what regulators need, as well as what they want to assure labelling capabilities and equipment are 100% compliant.
Contact us today for comprehensive labelling systems and vision inspection solutions ready to simplify the complexities associated with serializing and marking your pharmaceutical products.
If you would like to know more about how our vial and ampule labeling solutions, find our labelling solutions guide her