GMP電子報第28期

1
GMP
100 10 15
28
GMP
USP 35
Microbial Characterization, Identification, and Strain Typing
<1113>
1
USP
Microbial Examination of Non-sterile Products: Acceptance

Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
<1111>
nonsterile preparations
bioburden
Microbial Enumeration Tests
<61>Microbiological
Examination of Nonsterile ProductsTests for Specified Microorganisms <62>
total aerobic microbial count
TAMCtotal combined yeasts and molds countTYMC
1 2
individual results
replicate counts direct plating methods
1 2
---101 cfu=20
---102 cfu=200
---l03 cfu=2000
1
* EP7.0
TAMC 103 CFU
GMP 2
28
100 10 15
TAMC 104
CFUTYMC 102 CFU
* 3 4 JP15
prescribed tests
indicated acceptance criterionlimit of

detection
1. USP33
1g
cfu/g cfu/mL cfu/g cfu/mL 1mL
103
102
102
10
10
10
102
101
102
101
102
101
10
10
102
101
102
101
102
101
102
101
2. USP33
cfu/g cfu/mL
cfu/g cfu/mL
100 10 15 28
3 GMP
103
102
3. JP15

cfu/g cfu/mL cfu/g cfu/mL
20
20
100
50
100
50
100
50
100*
50*
1000
100
1000
100
100
50
4. JP15
cfu/g cfu/g
cfu/mL
cfu/mL
1000
100
z
z
z
z
z
z
GMP 4
28
100 10 15
cGMP
objectionable microorganisms
""
microbial content
-/container closure system-/
(
)
1. USP 33Microbial Examination of Non-sterile Products: Acceptance Criteria for

2.
Pharmaceutical Preparations and Substances for Pharmaceutical Use <1111>

EP 7.0Microbiological quality of non-sterile products for pharmaceutical use
3.
<5.1.4.>
JP 15Microbial Attribute of Nonsterile Pharmaceutical Products <General
4.
5.
Information12>
FDA's HUMAN DRUG CGMP NOTES (Volume 6, Number 1) March, 1998
GMP Questions and Answers / may 12, 2006 (Health Canada / Health Products
and Food Branch Inspectorate)
1.
2.
PIC/S
PIC/S 103 12 31
GMP PIC/S
PIC/S
10/8 PIC/S
100 10 15 28
3.
4.
5.
6.
5 GMP
11 5 PIC/S
5 PIC/S
PIC/S
PIC/S
103 12 31 GMP
2011 GMP QMS
7.2
9
5 6 200
GMP
3.2
100 9 13 76
GMP
3.2
100 9 21 22
100
GMP
3.2
100 10 4 6
213
GMP 28
100 10 15
11561 161-2
(02)27878000
http://www.fda.gov.tw
97 3 12
gmp@fda.gov.tw

GMP電子報第28期

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GMP電子報第28期

Uploaded by

Copyright:

Available Formats

1

Microbial Examination of Non-sterile Products: Acceptance

indicated acceptance criterionlimit of

1. USP 33Microbial Examination of Non-sterile Products: Acceptance Criteria for

Pharmaceutical Preparations and Substances for Pharmaceutical Use <1111>

2011 GMP QMS

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