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[PharmSciTech]Re: Difference between GMP and cGMP

Kanran Mkzaman,


In general, the term "GMP" (an apparent
acronym for the phrase "good manufacturing
practice") is not officially (legally)
defined in the "mutual recognition"
regulatory framework developed between the
US and the EU.


The DEFINED term is "GMP's"
[see, for example,
21 CFR PART 26--MUTUAL RECOGNITION OF
PHARMACEUTICAL GOOD MANUFACTURING PRACTICE
REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT
REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT
EVALUATION REPORTS: UNITED STATES AND THE
EUROPEAN COMMUNITY at Section Sec. 26.1
Definitions, paragraph c:

>(c) Good Manufacturing Practices (GMP's).
>[The United States has clarified its
>interpretation that under the MRA, paragraph
>(c)(1) of this section has to be understood as
>the U.S. definition and paragraph (c)(2) as
>the EC definition.]
>     (1) GMP's mean the requirements found in
>the legislations, regulations, and administrative
>provisions for methods to be used in, and the
>facilities or controls to be used for, the
>manufacturing, processing, packing, and/or
>holding of a drug to assure that such drug
>meets the requirements as to safety, and has
>the identity and strength, and meets the quality
>and purity characteristics that it purports or
>is represented to possess.
>     (2) GMP's are that part of quality assurance
>  which ensures that products are consistently
>produced and controlled to quality standards.
>For the purpose of this subpart, GMP's include,
>therefore, the system whereby the manufacturer
>receives the specifications of the product and/
>or process from the marketing authorization/product
>authorization or license holder or applicant and
>ensures the product is made in compliance with
>its specifications (qualified person certification
>in the EC).
>


The term CGMP is the PROPER American English
acronym for the phrase:
  "current good manufacturing practice"
which is derived from 21 U.S.C. [Title 9,
Subchapter V, Part A] Sec. 351(a)(2)(B)
which states [with CAPITALIZATION added for
emphasis]:
>
>  TITLE 21 - FOOD AND DRUGS
>   CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
>    SUBCHAPTER V - DRUGS AND DEVICES
>     Part A - Drugs and Devices
>     Sec. 351. Adulterated drugs and devices
>     A drug or device shall be deemed to be adulterated -
>     (a) Poisonous, insanitary, etc., ingredients;
>         adequate controls in manufacture
>       (1) ...
>       (2)(A) ...; or (B) if it is a drug and the
>     methods used in, or the facilities or controls
>     used for, its manufacture, processing, packing,
>     or holding do not conform to or are not perated
>     or administered in conformity with CURRENT GOOD
>     MANUFACTURING PRACTICE to assure that such drug
>     meets the  requirements of this chapter as to
>     safety and has the identity and strength, and
>     meets the quality and purity characteristics,
>     which it purports or is represented to possess;
>


In my decades of looking into the usage of the acronyms
CGMP, cGMP or GMP, it has been my general experience
that those who are (a) REGULATED by the FDA and (b)
truly quality oriented, including U.S. officials, use
the proper acronym, CGMP, while those regulated by the
FDA but with lesser quality imperatives prefer the
term cGMP while those who have a different regulatory
perspective use GMP.


However, most U.S. regulatory officials seem NOT to
care whether the acronyn used for the phrase "current
good manufacturing practice" is CGMP or cGMP just as
they admit that they do not rigorously enforce several
of the clear requirement minimums set forth in 21
C.F.R. Part 211 governing the CGMP for finished
pharmaceuticals, including those that require the
firms to PROVE that their sampling and testing plans
provide "representative" samples or that their
testing for release includes valid "statistical
quality control criteria."


Technically, the use of the acronym, cGMP, for the root
phrase "current good manufacturing practice" conveys the
sense that cGMP is some form of "GMP" (an obvious acronym
for "good manufacturing practice"), the "current" form,
as if there are other forms (or degrees) of "GMP," which
is not the case.

Usually, those who use the correct statutorially
derived acronym "CGMP" and and the regulatorily
defined "GMP's" (rather than "cGMP" and/or "GMP")
have a better understanding of what the true
requirement MINIMUMS are for CGMP and what are the
important differences between the regulatory
framework of the U.S. and that of the EC when it
comes to ensuring that each lot or batch of drug
released into commerce has the quality
characteristics that said lot or batch is claimed
to possess.


Hopefully, this post has provided you with the
differences between the acronym "CGMP" and the
acronym "GMP's" as they are "defined" as well as
the origin of the acronyms "cGMP" and "GMP" as
they were derived from the original "CGMP."


As far as an example of the real-world difference
between CGMP and GMP, consider the following
example for the testing of lots or batches of a
drug product for acceptance and release for
distribution:

  A firm that has adopted the approach to testing
  each lot or batch of drug product to determine
  if its quality in the manner defined defined in
  the US CGMP regulations (commonly called
  "statistical quality control") and using the
  approach embodied in ISO 3951 for its plan
  for the acceptance (or rejection) of each lot
  or batch of drug for release as set forth in
  21 C.F.R. Sec. 211.165(d) is operating under
  the CGMP minimum.

  Wheras, a firm that ONLY uses the USP sample
  numbers/amounts and monograph specifications'
  criteria for release could be considered to be
  operating under some form of "good manufacturing
  practice" (GMP) though its approach is NOT up
  to the clear "statistical quality control criteria"
  requirement minimum set forth in the US CGMP
  regulations for finished pharmaceuticals (21
  C.F.R. Part 211).


Hopefully, the preceding has not only addressed
what the "proper" acronyms should be but also
shown you their derivation and provided you with
a clear example of the difference as you asked.


Respectfully,

Dr. King
http://www.dr-king.com

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