December 21st, 2015

Validation Essentials: Three Must-Dos to Achieve Compliance

Validation of your converting processes is critical, and GAMP is your guiding light. Developing your validation attributes requires focus on three critical areas, with a particular emphasis on the quality attributes that define your product.

 

Good Automated Manufacturing Practices (GAMP) are the guidelines for manufacturers and users of automated systems in the pharmaceutical industry. Because of the regulatory nature of pharmaceuticals, GAMP was established to ensure quality through each stage of the manufacturing process.

Sounds great in theory, but in reality, there are parts of the entire process that don’t always live up to GAMP’s standards. Whether it’s due to a business decision here or a manufacturing oversight there, sometimes the process breaks down. Then audits occur. Then pain.

No one in this business is interested in pain (especially because in pharma industry, there is chance that literal pain could be inflicted on a patient or end user), and so we strive to uphold GAMP. These three key areas can help you reach that objective.

Three Impact Areas for Validation in Medical Manufacturing

Wikipedia defines Validation in the following way: “Establishing thorough documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.”

Quite the mouthful, isn’t it? But there’s a lot of relevant info packed into that overflowing sentence. In essence, you need “documented evidence” that you’ve met both “predetermined specifications” and “quality attributes.”

DeltaModTech Validation Quote

We’ve described each area in broad strokes, and then highlighted the key items for validation. The bold items must be in place, otherwise it will be difficult to proceed with document creation and guarantee compliance.

1. Documented Evidence

You need to produce a deliverable that validates how your machine and your processes meets specific standards. Your documented evidence can take many forms — a separate document, an FDS, a disaster recovery procedure.  

Within that documentation, there are certain protocols that you must follow. For example, let’s say you have a module attached to your machine, and you refer to it as an “island placement station.” In the documented evidence you have of the machine – schematic drawings, etc. – any references to that module must be consistently written as “island placement station.”

Key Items for Validation

  • List of relevant regulatory standards
  • Drawings defining product tolerance
  • Product identification: Liners, adhesives, active drugs, etc.
  • Parameters for critical processes: heat sealing: time/temp/pressure, Nip and die pressures, unwind and rewind tensions, etc.
  • Chemistry (volumes, components)
  • Fabrication methods, including certs if needed
  • Surface finish requirements, including certs if needed
  • Raw material requirements, including certs if needed

2. Predetermined Specifications

These are the specifications relative to the standards you must maintain. They may be regulatory standards such as CE, EU, FDA, OSHA, guidance such as GAMP, and/or internal company standards such as ISO 13485.

Clearly defining these pre-determined specs will help you throughout the manufacturing process. For example, are there dust requirements in the manufacturing process – and does your facility meet them?

When we work with clients, we carefully discuss their needs and their pre-determined specifications upfront, before we even begin designing a machine.  

Key Items for Validation

  • Process requirements / outline
  • Process timeline
  • Process resources
  • Change control requirements
  • Utility / electrical requirements
  • Room layout / spec considerations
  • Example of documents which meet requirement
  • Process layout

3. Product Quality

Arguably, this is the most important element of validation, and it can also be the most difficult. That’s because your success will be defined by the level of detail you produce.  

From the materials used in production to the tolerances of the end product, the more specific you are in defining the product quality the more successful your equipment manufacturer will be.  If you want us to guarantee quality test strips, for example, you need to be specific about what materials you plan on using, and provide us with samples of the materials to test our machines.

Key Items for Validation

  • Health and safety requirements
  • Control system requirements
  • Production rate/materials
  • Production rate/tolerances
  • Production material data sheets
  • Preferred suppliers
  • Spare parts requirements

Why Do Teams Struggle Writing Their Own Attributes?

Creating your own attributes for validation is no easy task, probably because regulatory agencies prefer that this be a multi-disciplinary approach. In an ideal world, that involves input from quality control, engineering, suppliers — everyone who is involved in the process should have a hand in creating these attributes.

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Getting all those parties involved in the process is a challenge on multiple levels. However, if you start early, include your supplier in the process, and use the three GAMP areas we’ve detailed here, achieving validation is a much easier task.

For more information on our validation support package, contact your Delta ModTech Manufacturing expert.

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