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Good Manufacturing Practices Support

Why does your organization care about Good Manufacturing Practices?

Good Manufacturing Practice (GMP) ensures that your business has controls in place to consistently design, develop and delivery your products to meet quality standards.

What are Good Manufacturing Practices?

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any product production that cannot be eliminated through testing the final product.

GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.

Below are some elements for Good Manufacturing Practices:

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Buildings and Facilities Management

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Equipment Log

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Equipment Maintenance, Cleaning and Calibration

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Risk Management for Process Controls

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Risk Management for Product Controls

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Cleaning Validation

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Production and In-process Controls

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Materials Management

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Packaging and Labeling

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Laboratory Controls

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Personnel

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Complaints and Recalls

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Change Control

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Computer Systems

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Safety Regulations

Why Kreative?

WE WORK IN PARTNERSHIP WITH YOU

As an ISO 9001 certified organization, Kreative applies Quality Management Principles to our work. We integrate your business requirements, production activities, business continuity plans, and recall procedures, along with risk controls, to create a culture of excellence by employing best practices, techniques, and technology. We diligently work with you as a teaming partner to help design and develop standard organizational processes, allowing your businesses to go beyond process standards, by looking at your business goals to establish performance targets that drive REAL results!

WE USE AN INNOVATIVE APPROACH

Kreative has prepared many companies and supported GMP external audits using multiple Registrars. We have developed techniques and tools to integrate your efforts across your organization. We apply a level of simplicity to your organization that will keep you compliant and help you stay on track.
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Leverage SharePoint

Kreative will work with you to set up document and database repositories to organize your business assets that will provide easy access for everyone in your organization and external auditors who will review these assets as part of the certification process

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Utilize Our In-House kARM (Audit Readiness) Tool

Kreative understands the substantial effort and cost associated with preparing for external certifications and assessments. Our kARM tool allows an organization to organize according to each model but also, more important leverage its assets to satisfy the various requirements. For example, both the ISO and CMMI models focus on Project Management and your organization’s Project Management assets can be linked within the tool, saving you time, effort, and cost.

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