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 The FDA has issued a Draft Guidance for Industry, Submission of Laboratory Packages by Accredited Laboratories in 2009.This standard comprises five elements - Scope, Normative References, Terms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.
From The Corner Lab - Blog Posts
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
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.”
Quantex Laboratories has completed the expansion of its GMP analytical laboratory with its relocation to a larger, state of the art facility at 3000 Eastpark Boulevard in Cranbury, New Jersey. With the new facility nearly four times the size of Quantex Laboratories’ previous site, the company is also adding microbiological testing capabilities later in the year to its contract laboratory and analytical testing CRO services.