General Chapters Group
Cycle 2015-2020
Horacio Pappa, Ph.D.
Director, General Chapters
2015-2020 Council of Experts
2
General Notices # 4.20. General Chapters

Describe the basics of commonly used analytical techniques and how
they apply in compendial testing

Contain descriptions of tests and procedures for application through
individual monographs.

Other compendial requirements

General guidance to manufacturers of official substances or official
products (>1000).

Dietary supplements general tests (>2000)
General Chapters Group – Demographics
Committee
Portfolio
(number of
chapters)
Total
%
International Domestic
volunteers
new
Chemical analysis
90
21
5
16
31
Physical analysis
39
20
3
17
40
Statistics
9
15
6
9
27
Dosage Forms
52
28
4
24
31
Packaging, Storage
and Distribution
32
16
5
11
44
Microbiology
51
14
1
13
43
114
24
90
40
Total
General Notices # 3.10 Applicability of Standards
Official USP 39

The identity, strength, quality, and purity of an article are determined by the
official tests, procedures, and acceptance criteria, and other requirements
incorporated in the monograph, in applicable general chapters, or in the General
Notices and Requirements. Applicable general chapters means general
chapters numbered below 1000 or above 2000 that are made applicable to
an article through reference in General Notices and Requirements, a
monograph, or another applicable general chapter numbered below 1000.

General chapters numbered 1000 to 1999 are for informational purposes
only. They contain no mandatory tests, assays, or other requirements
applicable to any official article, regardless of citation in a general chapter
numbered below 1000, a monograph, or these General Notices and
Requirements.
Current Classification of Chapters



GENERAL TESTS AND ASSAYS (<1000)
– General Requirements for Tests and Assays
– Apparatus for Tests and Assays
– Microbiological Tests
– Biological Tests and Assays
– Chemical Tests and Assays
• Identification Tests
• Limit Tests
• Other Tests and Assays
– Physical Tests and Determinations
GENERAL INFORMATION (>1000)
DIETARY SUPPLEMENTS (>2000)
6
Numbers available for new chapters
General Requirements for Tests and Assays
Current
span
1-20
Apparatus for Tests and Assays
21-50
25
Microbiological Tests
51-80
20
Biological Tests and Assays
81-180
82
Chemical Tests and Assays - Identification Tests
181-200
15
Chemical Tests and Assays Limit Tests
201-300
73
Chemical Tests and Assays Other Tests and Assays
301-600
250
Physical Tests and Determinations
601-999
305
General Information
1001-1999
791
GC Category
Slots
available
12
7
Recommendations
1) When selecting a number for a new general chapter, choose a number
available from the desired category avoiding, if possible, the use of the decimal
point notation.
2) For a procedural chapter that contains several related methods. The preference
is to include all the methods in one chapter instead of using the decimal point to
numbering subchapters. The methods within the chapter should be identify as
Method 1, 2, etc.
3) If it has been determined that the sub classification using decimal notation will
best meet the current needs, the root general chapter number will not change.
For example, the root general chapter <133> will not change to <133.0>.
4) When the decimal point is introduced into a new series of chapters, a root
general chapter must be created.
5) In the case of general information chapters, there are no restrictions and they
may be sub-classified as deemed necessary, however, rules (3) and (4) will
apply.
8
General Chapters Group – Reference
standards
•
There are 220 reference standards used in GCs
•
Approval of a new lot or a replacement lot of a reference
standard is the responsibility of the pertinent EC
•
Volunteers will work with the Reference Standard Scientist
during the development of reference materials
General Chapters – Topics of interest


Chemical Analysis Expert Committee
–
Elemental Impurities
–
Spectroscopy
–
Residual Solvents
–
Chromatography
–
Validation
Dosage Forms Expert Committee
–
Product Quality Chapters by Route of Administration
–
Veterinary Products Quality and Performance
–
Modern dosage forms: Nanoparticles, transformational dosage forms,
nanoemulsions, etc
10
General Chapters – Topics of interest

Microbiology Expert Committee
– Aseptic Processing
– Modern Microbiological Methods

Physical Analysis Expert Committee
–
Rheology for pharmaceutical dosage forms with DF-EC
–
Excipients Performance
–
Tablet Compression Characterization
–
Image Analysis of Particles
11
General Chapters – Topics of interest


Packaging, Storage and Distribution Expert Committee
–
Modernizing Packaging Material Standards (Plastic, Glass, Elastomers and
Metal)
–
Good Distribution Practices
–
Biocompatibility Testing of Packaging Systems and Medical Devices
Statistics Expert Committee
–
<1210> Statistical Tools for Procedure Validation
–
Content uniformity for large samples
12