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Facility Compliance

As information and technology evolve, systems and processes change. Pharmaceutical firms must ensure they stay compliant with industry regulations. This often requires businesses to alter, add to, or relocate their facilities. These modifications typically involve:

  • Specific Facility Components
  • Compounding
  • Raw materials
  • Equipment utilized
  • Staff
  • Drug classification
  • USP regulatory standards such as 795, 797, 503b, and the evolving 800

B&L Builders, Inc. consolidates these factors and puts every penny to good use to ensure your facility meets compliance for the long term. We adapt your facilities to fit fields including non-sterile compounding, low-risk compounding and radio pharmaceuticals, high-risk compounding, and hazardous drugs.

What We Do

Clean Design: Innovative Methodology

Utilize resources to get the job done right the first time

Proactive Resource Management

Unify architects engineers, inspectors, and other industry professionals to design facilities
Anticipate inevitable changes in regulation and technology

Clean Design Process

Planning & Resource Allocation

PHASE 1:
Planning & Resource Allocation
Identify resources and personnel needed including designers, consultants, engineers, and inspectors.

Design

PHASE 2:
Design
Analyze the flow of daily operations, types of compounding used, equipment, systems, raw materials, and drugs stored or used in the facility.

Compliance Audit

PHASE 3:
Compliance Audit
Ensure facilities meet standards set by the FDA, DEA, USP, and State Pharmacy Boards. B&L Builders ensures facility compliance with current regulations and keeps a watchful eye on upcoming mandates including the evolving 800.

Construction

PHASE 4:
Construction

Construction Closeout

PHASE 5:
Construction Closeout
Clean the new facility, complete unfinished tasks, walk through facility inspection with the client, and provide certification when applicable.

CONTACT US

We help pharmaceutical companies achieve regulatory compliance quickly and affordably. Our team of professionals work hard to design, build, and certify your facility. B&L Builders tackles projects of all sizes and works with some of the industry’s top pharmaceutical firms. Call us today to learn more about Clean Design and get a free estimate for your project.

Clean Design Process

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