From The Corner Lab - Blog Posts

Why is ISO 17025, and not just GMPs, Important to You?

Posted by Jim Menoutis on Mon, Mar 28, 2016 @ 10:58 AM

Current Good Manufacturing Practices (cGMPs), are the regulatory framework  mandated by law, and enforced by the US Food and Drug Administration (FDA).  They encompass not only drug (21CFR 210-211), but also dietary supplements (21 CFR 111), pharmacy compounding (21CFR 216),  biologics (21CFR 600-680), medical devices (21CFR 820), and cosmetics.   cGMPs are defined as that part of quality assurance aimed at ensuring products are consistently produced and controlled implementing the quality standards appropriate for their intended use.

They provide systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This includes the establishment of strong quality management systems, robust operating procedures, use of suitable quality raw materials, procedures for detecting and investigating quality deviations, and maintaining reliable laboratory testing capabilities.  It is important to note that cGMPs are minimum requirements.

ISO 17025, General Requirements for the Competence of Testing and Calibration Laboratories, was first published in 1999 as Guide 25, by the International Standards Organization.  In 2005, it was updated as ISO/IEC 17025:2005.   In most major countries, ISO/IEC 17025 is the standard by which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a laboratory that does not hold this accreditation.  The FDA  has issued a Draft Guidance for Industry, Submission of Laboratory Packages by Accredited Laboratories in 2009.This standard comprises five elements - Scope, Normative References, Terms and Definitions, Management Requirements, and Technical Requirements. It is the single most important International Standard governing laboratory quality systems.  Laboratories that are accredited to this International Standard have demonstrated that they have very robust quality systems, are technically competent, demonstrate the calibration and suitability of equipment, and are able to produce precise and accurate test data.

While there are many overlapping similarities between cGMPs and ISO 17025, there is also one significant difference. cGMPs are the minimum requirements mandated by law, and dictate what must be done, but not necessarily how to do it.   ISO 17025, on the other hand, is voluntary, not only dictating what must be done, but also providing the guidance of how to do it.  It is important to note that FDA operates its own laboratories according to ISO 17025, holding third party accreditation under this international standard, as well.   

So why is ISO 17025 important to you?   It helps determine which laboratory can deliver accurate and precise results.  A laboratory that has achieved ISO/IEC 17025:2005 accreditation has met the international standard of testing excellence, demonstrating technical competence, a robust quality system, precise and accurate tests, and suitably calibrated equipment. In fact, the ISO states, "Laboratory customers, regulatory authorities and accreditation bodies may also use ISO/IEC 17025:2005 in confirming or recognizing the competence of laboratories."  A company or vendor  that has implemented a quality system, incorporating both cGMPs and ISO 17025, is displaying a strong commitment to quality, and values the importance that quality plays in the research, development, and manufacturing processes. 

Quantex Laboratories maintains a robust quality system that complies with cGMPs, as well as GLPs. We are also ISO/IEC 17025:2005 accredited, holding the same accreditation scope, and accredited by the same ISO accreditation body  as many of the FDA’s own laboratories  This accomplishment is a tribute to both the robust quality systems, and the broad scope of capabilities  in place at Quantex Labs, as well as the superior technical competency of our staff.    We are also one of the very few labs, nationally, to hold accreditation for Elemental Impurities. Quantex is very proud of this record, and continues to remain committed to quality systems for the integrity of our data.

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Topics: cGMP, FDA, ISO, ISO 17025, Lab Accreditation

New Guidance Available for Elemental Impurities: Meeting Compliance with USP, ICH Q3D, FDA and GMP Requirements.

Posted by Jim Menoutis on Tue, Oct 27, 2015 @ 02:01 PM

A new guide is available covering meeting compliance with USP<232> & <233>, ICH Q3D, FDA’s and GMP requirements. The guide details time lines for compliance, including FDA and EQDM/EMA deadlines for both existing and new drug products. In addition to covering USP’s requirements , it also provides an in depth analysis of FDA’s requirements for complying with ICH Q3D. The guide also covers what will be needed to demonstrate compliance with elemental impurities during FDA GMP inspections.  Click Here to Download


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Topics: USP, cGMP, USP <232>, FDA, ICH, Q3D, FDA ANDA,

Elemental Impurities: Where we were then, Where we are now, and Where are we going

Posted by Jim Menoutis on Tue, Sep 22, 2015 @ 05:44 PM

On Wednesday, September 9, 2015 the FDA published the final Q3D Elemental Impurities Guidance for Industry. At the same time, Contract Pharma Magazine published a feature article in its September issue on elemental impurities. The feature discusses elemental impurities in depth with perspectives on USP and regulatory the expectations from both FDA and EMA. The article notes that” …In both Europe and the US, the EQDM/EMA and FDA deadlines for compliance of new marketing authorization and new drug applications, respectively, with ICH Q3D are each set for June 2016…” to access the article in full click below:

Click here to access the article

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Topics: USP <232> USP <2332>, Elemental Impurities, USP <233> elemental Impurities, FDA, ICH

FDA Draft Guidance Under FDASIA States That Delaying, Denying, Limiting an FDA Inspection Could Deem A Drug Misbranded or Adulterated

Posted by Jim Menoutis on Thu, Nov 07, 2013 @ 03:27 PM

On July 12, 2013 the FDA released a Draft Guidance,  Guidance for Industry Circumstances  that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, for comment. The Draft Guidance was issued in support of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under Section 707(b) of FDASIA, the FDA was required to issue  guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j).  This is because 501(j) adds a new twist to what is deemed  an adulterated drug.  Specifically, Section 707 of FDASIA adds 501(j) to the Food, Drug, and Cosmetic Act (FD&C Act) to deem adulterated a drug that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”

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Topics: Establishment Inspection, Inspection, cGMP, Drug facility Inspection, FDA, Aduterated, Misbranded, FDA Inspection

ICH Issues Q3D step 2b Elemental Impurities Guideline; USP & EMA Take Action

Posted by Jim Menoutis on Wed, Aug 28, 2013 @ 05:17 PM

The International Conference on Harmonization (ICH) has started the consultation period on elemental impurities. ICH Q3D - Impurities: Guideline for Elemental Impurities - laying out limits for metallic impurities in pharmaceutical ingredients and preparations and detailing the testing procedures used to detect and measure them.  With the July 26, 2013 issuance of the guideline, Q3D has now entered step 2b of a five-step implementation process. There is a six-month comment period which gives  the industry and other stakeholders time to forward their comments.

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Topics: Elemental Impurities, CHMP, USP <232>, USP <233> elemental Impurities, FDA, ICH, Q3D, EMA

Teva Pulls Generic Version of Wellbutrin XL From U.S. Market

Posted by Jim Menoutis on Fri, Oct 05, 2012 @ 02:31 PM

Teva Pharmaceuticals is pulling its generic version of Wellbutrin XL. After extended testing, the FDA has determined that Teva's generic isn't equivalent to the branded drug. And now, the FDA is requiring other generics companies to test whether their own versions of Wellbutrin XL are acceptable (read Bloomberg story).

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Topics: Generic Version, Generics, FDA, Teva, Wellburtin XL, Budeprion XL

FDA Launches Antibacterial Drugs Task Force

Posted by Jim Menoutis on Tue, Oct 02, 2012 @ 12:32 PM

The U.S. Food and Drug Administration is creating an internal task force to help it develop and revise guidance on antibacterial drug development and address the growing crisis of antibiotic resistance.

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Topics: FDA, Antibacterial Drugs, Antibiotics, drug resistant bateria