Equipment Design, Commissioning, and Qualification for Biopharma Facilities

process validation

Process Validation for Biopharma Facilities

cleaning and sterilization

Cleaning and Sterilization for Biopharma Facilities

Life Science Industry Services

Assuring project success across FDA and international medicinal health
agency regulated industries

equipment CQV

PROJECT
MANAGEMENT

AM Life Science provides experienced master plan development and project management enabling successful project execution.

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validation project management

CQV / PV

AM Life Science provides the knowledge and practical experience to develop and implement a custom tailored Commissioning, Qualification, Validation (CQV) and Process Validation (PV) program for your specific needs.

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cqv program development

ENGINEERING
SERVICES

We support engineering efforts of construction completion, equipment start-up, commissioning and operational readiness, process optimization and manufacturing support.

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process validation

CLEANING
DEVELOPMENT

AM Life Science is an invaluable resource in your cleaning development program, including authoring, training and executing Clean In Place (CIP), Clean Out of Place (COP) and Steam In Place (SIP) protocols.

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cleaning and sterilization

CONSTRUCTION
QUALITY

We have the expertise to bridge between the design, construction, quality release, commissioning and qualification. Our approach is to deploy quality by design (QbD) methods throughout the construction process.

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Recent News

Aug 15 2018

The USP 61 and USP 62 Updates You Need to Know

In 2009, the United States Pharmacopeia (USP) issued harmonized reference standards for the Microbiological Examination of Non-Sterile Products. While AM Life Science (AMLS) does not offer services that directly support method validation...

Jun 18 2018

The CQV Process: Where to Get Started

CQV (Commissioning, Qualification, and Validation) is a very detail-oriented process that requires the right mix of knowledge, experience, and diligence to correctly place equipment/systems into use. Additionally, with FDA regulations and requirements...