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.
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 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:
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
Procurement strategies for a vial labelling machine begin with a customer specifying the requirements. Once a customer knows the requirements, a User Requirement Specifications (URS) is sent to potential suppliers to start a dialogue. The discussions with the supplier then lead to an updated and final URS. Changes may be made to the first URS draft as a customer gains more knowledge and understanding during talks with the supplier and therefore changes, adds or removes certain requirements.
This purchasing conversation with suppliers covers a lot of ground and setting priorities can help. The following five considerations should lead the conversation and help to deliver a holistic vial labelling solution, not just a machine:
One of the first things an equipment purchaser should know is if the machine has the capacity to meet desired production targets. Does it have the capacity and flexibility required?
How will it fit into the production environment? Can it deliver the throughput needed without compromise the quality? Will it be integrated in-line or stand alone? This part of the dialogue is fundamental; can the equipment do the job?
Pharma’s regulatory environment is one of the strictest there is, and the regulatory foundation of the vial labelling technology should be given top priority. A machine suited for the pharmaceutical business must be able to answer regulators with a deep dive of documentation including URS, DS, DQ, IQ/OQ, PQ and FMEA risk analysis. Customers must decide, usually based on work load, whether they are able to create the documents themselves, outsource the task to the supplier or hire a consultant company.
Delivery timing is always critical to meet project deadlines. The interests of both supplier and purchaser often collide here so it is important to come to mutually agreeable timeframe. Beyond the technical capabilities of the machine this may be one of the most important aspects of any equipment purchase.
Details of the machine, the number units purchased and other variables set the timeline, as does the orderbook of your vendor. All of these variables can add weeks and months to delivery timing and can clash with business plans if not sorted.
When both parties have a clear understanding of the delivery expectations the better it serves the purchasing experience and ultimately access to the labelling capabilities being sought in the first place.
One of the great things about modern vial labelling machines is their engineered reliability. Most vial labelling machines don’t usually come with service technician attached. There is a certain amount of trust involved, but most equipment buyers considering a purchase should seek a little proof. Ask for reference cases, but also ask about what the vendor might offer in after sales services to support continuous improvement in labelling operations.
Although a priority consideration, purchase price is rightly last on the list. The four prior considerations need to be asked, then answered first before comparing the prices of vendors labelling machines.
If the machine being specified doesn’t meet key criteria, and the vendor’s quality and machine performance is not able to meet the needs of the organization now or into the future, then no matter what the purchase price that risk is too expensive.
Purchasing capital equipment is a challenging process. It needs to be done with a straightforward planned approach to ensure the investment is not wasted. Aligning manufacturing business interests with experienced vendors who’ve already considered the above are likely to yield the best machine for the investment.
If you are interrested in more information about vial labeling, please download our ebook about vial labeling here
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