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Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief
Bacterial
endotoxins cause fever, septic shock, and other disease symptoms — and thus
attract considerable regulatory scrutiny from such organizations as the U.S.
Food & Drug Administration (FDA) and the United States Pharmacopeial
Convention. Regulations require that devices that contact circulating blood or
cerebrospinal fluid, or are used with intraocular products or in vitro
fertilization procedures, are required to be endotoxin-free.
- Definition of endotoxins;
- Various tests used for their detection;
- Use of depyrogenation and other ways to remove
endotoxins;
- Types of devices that should be tested;
- Preparation and testing of samples;
- Options for sampling containers;
- Acceptance criteria for each of the assays; and
- Sources of official information, reference, and
guidance.
“The
Fundamentals of Endotoxin Testing” is authored by Steven Richter, Ph.D.,
said Steven Richter, Ph.D., president and scientific director of Microtest
Laboratories — and a former FDA official.
The
paper is one in a series about testing, manufacturing, and regulatory issues of
concern for medical device manufacturers from Microtest Laboratories, a leader
in testing services and contract manufacturing for medical devices,
pharmaceuticals, and biotechnology.
About Microtest Laboratories
Microtest Laboratories is a leader in testing
services and contract manufacturing for medical devices, pharmaceuticals, and
biotechnology. It was founded in 1984. The company’s expertise and flexible
processes enhance product safety and security, speed time to market, and
minimize supply chain disruption. Microtest’s unique single-source capability
to provide testing and manufacturing solutions allows the firm to support a
full pharmaceutical or medical device product release. The company’s facilities
in Agawam, Massachusetts, USA include state-of-the-art aseptic manufacturing
areas; analytical chemistry, microbiological, and virological laboratories;
Class 100 clean rooms; onsite steam and ethylene oxide sterilization, plus
depyrogenation capabilities; purified water systems; and voice/data systems. For
more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or
toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter
@MicrotestLabs on Facebook at http://goo.gl/TndoBg.
# # #
Labels: endotoxin testing, FDA, medical device, medical device manufacturing, medical device testing
New FDA Regulations Streamlining the Governance of Combination Products are Detailed in New White Paper
Combination products are
a large and growing segment of the medical device market. Some analysts
estimate they represent over 30% of all new FDA product submissions.
"Over the last 10
years, FDA regulatory centers have struggled with the changes and challenges
that these new technologies present. For manufacturers, the convergence of
drugs, biologics, and devices has created both a host of regulatory issues —
and many exciting opportunities," according to Steven Richter, Ph.D,
President and Chief Scientific Officer of Microtest Laboratories, Inc., and
author of the new white paper.
The new FDA publication,
"21 CFR Part 4 — Current Good
Manufacturing Practice Requirements for Combination Products," revises
regulations by establishing different categories of products. These included
single-entity products (such as a drug-eluting stent) and co-packaged products
(such as a packaged syringe and pharmaceutical). The rules also distinguished
between a drug with a device, a biologic with a device, and a device with an
HCT/P.
The new white paper discusses,
in detail and example, how the new FDA rules guide a manufacturer into one of
two approaches, depending upon the characteristics of their product.
According to Dr.
Richter, "the FDA's new streamlined approach for regulating combination
products is a big step forward for the practitioner. It applies parts of both
the QSR and GMP quality systems in a way that makes sense for the unique
characteristics of each combination product. 21 CFR Part 4 closes the gaps in
the 2004 guidelines and succinctly clarifies the process for establishing
quality systems that ensure compliance and patient health and safety.”
Based in Agawam, Mass.,
the company provides expertise and flexible processes that enhance product
safety and security, accelerate time to market, and minimize supply chain
disruption. For more information about Microtest Laboratories, visit microtestlabs.com or call 1-413-786-1680
or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter
@MicrotestLabs at http://twitter.com/MicrotestLabs.
Labels: biologic, combination products, FDA, Federal Food & Drug Administration, manufacturers, Medical Devices, paper, pharmaceutical, white, whitepaper
New White Paper Details What Compounding Pharmacies Must Know to Prepare for FDA Inspections
“The FDA requires all
compounding pharmacies to comply with USP section <797>, which outlines
the different standards and regulations for environmental control, testing, and
personnel training. Currently, the operations of large-scale compounders do not
fall under the scrutiny and regulation of the FDA. However, these facilities
may now face inspections from both the state regulatory authorities and the
federal government,” said white paper
author Steven Richter, Ph.D., president
and scientific director of Microtest Laboratories — and a former FDA
official.
In the white paper, Dr.
Richter advises compounding pharmacies on the critical issues to resolve prior
to an FDA or state inspection, including sterile compounding regulations,
quality testing, sterility testing of compounded articles, disinfectant
validations, and endotoxin testing.
“In the aftermath of the
NECC case, FDA and state actions regarding compounding pharmacies are
relatively certain: regulations and inspections will both tighten and increase.
The FDA, in some instances, will assume the role of lead auditor for the
compounding pharmacy’s operations,” Dr. Richter said. “It is critical for
compounding pharmacies to maintain a state of control in their controlled
environments. While there may always be excursions, it is the actions that are
undertaken after the excursions that will influence an inspector’s responses
and observations during an on-site investigation and inspection.”
Microtest Laboratories is a
Massachusetts-based, FDA-audited company with a history of exceptional
regulatory compliance. Microtest Labs’ environmental sciences group helps
clients maintain control of their controlled environments and is a proven
resource for contamination testing needs arising from the manufacturing of
medical devices or pharmaceuticals, as well as sterile compounding in hospital
pharmacies.
Labels: compounding pharmacies, compounding pharmacy, FDA, Federal Food Drug Administration, USP 797, USP 797 compliance, USP797, USP797 compliance, white paper, whitepaper
New White Paper Assists Medical Device Manufacturers with Changes to FDA Endotoxin Testing Guidelines
AGAWAM, MASS. —October 24, 2012 — A new white paper is
available to assist medical device manufacturers with understanding recent changes
to the U.S. Food and Drug Administration’s (FDA) thinking regarding endotoxin
testing. The paper is available to download from the Web at http://www.microtestlabs.com/medical-device-endotoxin-testing-paper.
In the paper, Dr. Richter discusses the FDA’s recently
published document, “Guidance of Industry Pyrogen and Endotoxin Testing:
Questions and Answers.” The FDA document replaced the agency’s 1987
Endotoxin Guidelines — now considered out of date as a result of changes in the
USP and pharmaceutical dosage forms. It presents the agency’s current position
regarding pyrogen and bacterial endotoxin testing requirements for
pharmaceuticals, biologics, and medical devices. Medical devices that contact
circulating blood or cerebrospinal fluid, or are used with intraocular products
or in vitro fertilization procedures, are required to be endotoxin-free.
In his new white paper, Dr. Richter reviews the FDA’s updated guidelines
on endotoxin testing and explains how they relate to medical devices. Since the
majority of pyrogens found on medical devices are bacterial in nature, the paper
focuses on those contaminates.
Some medical devices that are required by the FDA to be tested for
endotoxin are:
•
Intravenous catheters and tubing
•
Cardiac stents and angioplasty balloons
•
Certain implants such as pacemakers/defibrillators
•
Spinal catheters
•
Transfusion catheters
•
Intraocular lens implants
•
Cranial drills
•
Perfusion tubing
•
Dialysis tubing and filters
•
Vascular grafts
•
In vitro fertilization catheters
About Microtest Laboratories
Microtest Laboratories is a full-service medical device testing
laboratory and provider of related services for the medical device,
pharmaceutical, and biotechnology industries. Medical device testing is
performed in-house by seasoned regulatory microbiologists and chemists under
strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified.
Testing services include bioburden, sterility, endotoxin, accelerated aging,
and toxicity (ISO 10993). In addition, Microtest recently introduced a
fast-track test to screen plastics and polymers in medical devices for toxicity
using Zebrafish embryos.
Based in Agawam, Massachusetts, USA, the company provides
expertise and flexible processes that enhance product safety and security,
accelerate time to market, and minimize supply chain disruption. For more
information, visit http://www.microtestlabs.com, or call
1-413-786-1680 or toll-free 1-800-631-1680. Follow on Twitter at http://twitter.com/MicrotestLabs.
# # #
Labels: endotoxin, endotoxin testing, FDA, Guidance of Industry Pyrogen and Endotoxin Testing: Questions and Answers, manufacturers, Medical Devices
Industry Perspective on Reusable Medical Device Cleaning and Validation Requirements Outlined in New Management Brief
“Although the FDA guidance
document is not legally enforceable, it describes the agency’s ‘current
thinking and should be viewed as recommendations,’” said Steven Richter,
Ph.D., president and scientific director of Microtest Laboratories — a former
FDA official — and author of the brief.
- “Spore tag
reduction” and Hucker’s soil challenges
- Cleaning
methods using protein, carbohydrates, red blood cells and lipids
- Separation of cleaning,
disinfectant and sterilization validation activities
- ASTM Simulated
Use Test
- Three log
reduction for cleaning validations
- Empirical data
in 510(k) submissions
- Reducing manufacturing
materials to “safe levels”
While Richter emphasized that “the
FDA document was issued for comment and is not for implementation, the medical
device industry understands that changes from current best practices will be
required immediately.”
His brief seeks to “raise the
industry discussion of issues that must be anticipated, discussed, and thoroughly
evaluated for the time when implementation is required,” he said.
Dr. Richter founded Microtest Laboratories in 1984 after a
distinguished career at the FDA. Under his leadership, Microtest Laboratories
provides the medical device, pharmaceutical, and biotechnology industries with
premier testing and manufacturing support.
Microtest Laboratories, based in Agawam, Massachusetts, is a full-service
medical device testing laboratory and a leader in medical device testing and
related services for the medical device, pharmaceutical, and biotechnology
industries. Testing is performed in-house by seasoned regulatory
microbiologists and chemists under strict GMP/GLP regulations. Microtest is
both ISO 9000 and 17025 certified. Testing services include bioburden,
sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition,
Microtest recently introduced a fast-track test to screen plastics and polymers
in medical devices for toxicity using Zebrafish embryos.
# # # Labels: cleaning validation, FDA, FDA regulations, medical device, medical device cleaning, medical device testing, testing requirements, Validation requirements
New Scope of Reusable Medical Device Cleaning Validations is Examined in New White Paper
AGAWAM, MASS. – Nov. 2, 2011 – A new white paper detailing the new scope of reusable medical device cleaning validations is available free from Microtest Laboratories on the Web at http://www.microtestlabs.com/new-scope-cleaning-validation-paper. “Cleaning validation for reusable medical devices is an important step in proving their safety. Available guidance documents now indicate that the traditional method of validating cleanliness, spore log reduction, will no longer be acceptable. Analytical assays capable of providing quantitative results will now be required instead,” writes white paper author Patrick Kenny, Manager of Analytical Services, Microtest Laboratories. In the new white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” Kenny notes that “although a new requirement for reusable medical devices, these tests are traditional analytical assays that are performed routinely on other types of samples.” “An effective protocol and report that includes justifications for the test soil and assays chosen, as well as thorough documentation of all parameters used in the validation, will help ensure success for the device’s submission,” he notes. In the paper, Kenny also discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation. His recommendations are based on several key documents relating to reusable device cleaning validations that are either in draft or final form. They include AAMI document TIR30:2003, a comprehensive guide to medical device cleaning validations. TIR30 is currently in revision, and an updated version is scheduled for 2011 release. Kenny holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories. At Microtest, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide. Downloada free copy of the white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” from the Microtest Laboratories website at http://www.microtestlabs.com/new-scope-cleaning-validation-paper. Microtest's broad portfolio of medical device and combination product testing services include sterilization validation, reusable device studies, endotoxin and sterility testing, and package validation. About Microtest Laboratories Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs. Labels: cleaning, cleaning validations, FDA, med devices, Medical Devices, regulations, reusable medical devices, white paper, whitepaper
New White Paper for Dietary Supplement Manufacturers Provides How-to for New FDA Compliance Paradigm
Critical information that dietary supplement manufacturers must know in order to meet the Federal Food & Drug Administration’s (FDA) good manufacturing practices “compliance paradigm” is detailed in a free white paper available at http://www.microtestlabs.com/dietarypaper. The white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” provides how-to guidance for manufacturers of dietary supplements – a fast-growing market, which totaled $23 billion and more than 40,000 products in 2008. Just 15 years ago, the production of dietary supplements was regulated as food ingredients without oversight. Today, the FDA regulates their manufacture under the current Good Manufacturing Practices (cGMP) for Dietary Supplements, listed in 21 Code of Federal Regulations (CFR) 111. “Today, there’s a new paradigm for dietary supplement manufacturers – and it’s one of testing, manufacturing, and lot release. cGMP controls are used to assure that products meet the requirements of safety and have the strength and identity to meet the label claims. And label claims are the driver for all FDA regulatory actions,” said Steven G. Richter, Ph.D., RAC, SM (NRM), author of the white paper, and President and Chief Scientific Officer of Microtest Laboratories. “In fact, this new ‘compliance paradigm’ dietary supplement manufacturers is very similar to pharmaceutical manufacturing. The problem is that, for many small- and medium-sized companies which produce dietary supplements, compliance with the spirit and intent of the cGMPs is proving to be a challenge,” he said. For those manufacturers, the white paper provides a much needed overview and discussion of what’s required of the by the FDA, including how-to guidance on: - Developing the Necessary Quality System
- Management “Buy In”
- Microbiological Testing/Practices In The USP Dietary Supplement Compendium and FDA BAM
- Chemistry and Manufacturing Controls (CMC)
The white paper is available at: http://www.microtestlabs.com/dietarypaper. “The challenges for small and medium sized manufacturers are these: Testing dietary supplements and determining compliance requires the personnel and facilities to handle large-scale testing programs. The ability to train and retain these employees may be a challenge. And a full cGMP assessment is required for each manufacturer. “Compliance with the intent of the law will be determined by management’s buy-in to a robust quality program with concomitant lab support,” Richter said. “Given all this, for many small and medium sized manufacturers, outsourcing the majority of their testing may make most economical sense.” For a full discussion of the issues surrounding the FDA’s Good Manufacturing Practices (cGMP) for Dietary Supplements, download the new, free white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” from http://www.microtestlabs.com/dietarypaper. For more information, visit http://www.microtestlabs.com. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs. About Microtest Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Labels: Compliance, dietary supplements, FDA, Federal Food Drug Administration, good manufacturing practices
White Paper Outlines Disinfection Testing, Cleaning Validation Studies Requirements for Reusable Medical Devices
AGAWAM, MASS. – A new, free white paper outlining the application of disinfection and cleaning validation requirements for reusable medical devices in line with U.S. Food and Drug Administration (FDA) regulations is now available from Microtest Laboratories (http://www.microtestlabs.com/medical-disinfection-paper). Titled “Reusable Medical Device Disinfection and Cleaning Validation Requirements,” the paper outlines the salient aspects of validating that a medical device can be safely reused; addresses disinfection studies and processes, rather than sterilization; and provides cleaning validation information germane to all reusable medical devices. The author of the paper is Steven Richter, Ph.D., president and scientific director of Microtest Laboratories. Richter is himself a former FDA official. “Reusable medical devices come in all shapes and sizes — from specula to colonoscopes. Generally, these devices have expensive components that require them to be cleaned and disinfected or sterilized,” Dr. Richter notes. “Recently, the FDA began requiring additional information on 510(k) submissions, demanding clarity in the options afforded to practitioners. Microbiologists generally treat all medical devices equally, even though many devices require special treatment. “Historically, manufacturers were not required to validate that cleaning and disinfection processes were effective in reducing microbial and protein loads to safe levels. The FDA may have asked manufacturers for data regarding disinfectant use during reprocessing, but manufacturers would often simply perform cursory simulated-use tests that might not pass muster with FDA reviewers today. “Currently, the FDA requires validation studies for both disinfection and cleaning. Both disinfection testing validation and cleaning validation studies are important to the manufacturer because they will validate the safety and efficacy of the disinfection process. It is important to qualify both the cleaning and disinfecting processes prior to validation activities. “This new white paper is aimed at helping practitioners determine the best practices for performing these critical disinfection testing and cleaning validation studies,” Dr. Richter states. Download a free copy of the white paper “Reusable Medical Device Disinfection and Cleaning Validation Requirements” from http://www.microtestlabs.com/medical-disinfection-paper. Dr. Richter founded Microtest Laboratories in 1984 after a distinguished career at the FDA. Under his leadership, Microtest Laboratories provides the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support. About Microtest Laboratories Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs. # # # Press Contact: Don Goncalves, 781-793-9380, dgoncalves@tizinc.com Keywords: Cleaning validation studies, Disinfection testing, Reusable Medical Devices Labels: cleaing validation, disinfection testing, FDA, hospitals, Medical Devices, reusuable medical devices
New White Paper Helps Medical Device Manufacturers Apply New FDA Regs to Combination Products
AGAWAM, MASS. – July 13, 2010 – A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories ( http://www.microtestlabs.com/combination-products-20/) Combination products are a large and growing segment of the medical device market, with some analysts estimating they represent over 30% of all new product submissions to the FDA. As the market continues to grow, it is further compounded by the introduction of human tissue and cellular products (HCT/Ps) incorporated in combination products, which in turn, raise a host of new challenges for testing, sterilization, and contamination avoidance.  Over the past 12 months, the FDA has addressed the dichotomy of dual quality systems by developing streamlined regulations for Good Manufacturing Compliance. These regulations, designated as 21 CFR Part IV, are anticipated to become law by the end of 2010. Once promulgated, manufacturers will be held accountable for compliance and the FDA will use it as a legal document for enforcement. In the new white paper titled, “ Combination Products 2.0: Applying the New FDA Regulations,” Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., addresses the implications for manufacturers. (Download from: http://www.microtestlabs.com/combination-products-20). In the white paper, Dr. Richter discusses: • The New Regulations • Determining Principal Mode of Action — Device or Drug? • Stem Cells & Human Tissue in Combination Products • The Implications for Testing and Validation • An Example: Drug-Eluting Stents “The new FDA regulations governing combination products are a major step forward for the industry. They apply to parts of both the QSR and GMP quality systems in a way that makes sense for the unique characteristics of each combination product. 21 CFR Part IV closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety. The ability of manufacturers to understand, establish, implement reliable testing procedures will be critical in complying with these new requirements,” Dr. Richter said. Download a free copy of “ Combination Products 2.0: Applying the New FDA Regulations” from http://www.microtestlabs.com/combination-products-20/. Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest provides the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.  About MicrotestMicrotest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. # # # Labels: 21 CFR Part IV, biologic component, biotechnology, combination products, FDA, HCT/Ps, manufacturing, Medical Devices, Microtest Laboratories, pharmaceutical, regulations
New White Paper for Dietary Supplement Manufacturers Provides How-to for New Compliance Paradigm
AGAWAM, MASS. – April 5, 2010 -- Critical information that dietary supplement manufacturers must know in order to meet the Federal Food & Drug Administration’s (FDA) good manufacturing practices “compliance paradigm” is presented in a free white paper, available now for download from http://www.microtestlabs.com/dietarypaper. The white paper, “ Dietary Supplements — A New Paradigm for Manufacturers,” provides how-to guidance for manufacturers of dietary supplements – a fast-growing market, which totaled $23 billion and more than 40,000 products in 2008. Just 15 years ago, the production of dietary supplements was regulated as food ingredients without oversight. Today, the FDA regulates their manufacture under the current Good Manufacturing Practices (cGMP) for Dietary Supplements, listed in 21 Code of Federal Regulations (CFR) 111. “Today, there’s a new paradigm for dietary supplement manufacturers – and it’s one of testing, manufacturing, and lot release. cGMP controls are used to assure that products meet the requirements of safety and have the strength and identity to meet the label claims. And label claims are the driver for all FDA regulatory actions,” said Steven G. Richter, Ph.D., RAC, SM (NRM), author of the white paper, and President and Chief Scientific Officer of Microtest Laboratories. “In fact, this new ‘compliance paradigm’ dietary supplement manufacturers is very similar to pharmaceutical manufacturing. The problem is that, for many small- and medium-sized companies which produce dietary supplements, compliance with the spirit and intent of the cGMPs is proving to be a challenge,” he said. For those manufacturers, the white paper provides a much needed overview and discussion of what’s required of the by the FDA, including how-to guidance on: • Developing the Necessary Quality System • Management “Buy In” • Microbiological Testing/Practices In The USP Dietary Supplement Compendium and FDA BAM • Chemistry and Manufacturing Controls (CMC) The white paper is available at: http://www.microtestlabs.com/dietarypaper. “The challenges for small and medium sized manufacturers are these: Testing dietary supplements and determining compliance requires the personnel and facilities to handle large-scale testing programs. The ability to train and retain these employees may be a challenge. And a full cGMP assessment is required for each manufacturer. “Compliance with the intent of the law will be determined by management’s buy-in to a robust quality program with concomitant lab support,” Richter said. “Given all this, for many small and medium sized manufacturers, outsourcing the majority of their testing may make most economical sense.” For a full discussion of the issues surrounding the FDA’s Good Manufacturing Practices (cGMP) for Dietary Supplements, download the new, free white paper, “ Dietary Supplements — A New Paradigm for Manufacturers,” from http://www.microtestlabs.com/dietarypaper. For more information, visit http://www.microtestlabs.com. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs. About MicrotestMicrotest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. # # # Public Relations contact, Boston: Tiziani Whitmyre Inc., http://www.tizinc.com/public-relationsLabels: 21 Code of Federal Regulations, CFR 111, cGMP, compliance paradigm, dietary supplements, FDA, Federal Food Drug Administration, good manufacturing practices, regulations
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