Errata - English

In Standardization with visual end point: Change
M = mL edetate disodium × edetate disodium/mL ZnSO₄
to:
M = mL edetate disodium × M edetate disodium/mL ZnSO₄
AND
In Standardization with potentiometric end point: Change
M = mL edetate disodium × edetate disodium/mL ZnSO₄
to:
M = mL edetate disodium × M edetate disodium/mL ZnSO₄

Change
Standardization: Add 2 drops of phenolphthalein TS to 20 mL of 0.1 N potassium hydroxide VS. Titrate with 0.1 N hydrochloric acid VS until a permanent pale-pink color is produced.
to:
Standardization: Add 2 drops of phenolphthalein TS to 20 mL of 0.1 N hydrochloric acid VS. Titrate with the potassium hydroxide solution until a permanent pale-pink color is produced.

Line 2 of bullet 1 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/human/bwp/026895en.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003684.pdf
AND
Line 2 of bullet 2 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/human/bwp/179302en.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/WC500003675.pdf
AND
Line 3 of bullet 3 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/vet/iwp/074300en.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004575.pdf
AND
Delete bullet 4 of International Regulations and Guidance Documents in second paragraph
AND
Line 2 of bullet 5 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/human/bwp/TSE%20NFG%20410-rev2.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003712.pdf
AND
Line 1 of bullet 6 of International Regulations and Guidance Documents in second paragraph: Change
Terrestrial animal health code 2007. Available at http://www.oie.int/eng/normes/mcode/code2007/anc-en_summary.htm.
to:
Terrestrial animal health code. Available at http://www.oie.int/doc/ged/D10905.pdf.

In In-Process Controls/paragraph 2: Change
Refer to Risk Assessment for discussion on critical process parameters (CPP).
to:
Refer to Quality Systems for discussion on critical process parameters (CPP).
AND
In Final Product Release Specifications/Dose-Defining Assays/paragraph 3: Change
relay
to:
rely

A paragraph before the Introduction was deleted:
This chapter provides guidance and procedures used for characterization of biotechnology-derived articles by polyacrylamide gel electrophoresis. Portions of the chapter that are not harmonized with the other two pharmacopeias are marked by the symbol ♦. This chapter is harmonized with the corresponding chapter in JP and EP. Other characterization tests, also harmonized, are shown in Biotechnology-Derived Articles—Amino Acid Analysis <1052>, Biotechnology-Derived Articles—Capillary Electrophoresis <1053>, Biotechnology-Derived Articles—Isoelectric Focusing <1054>, Biotechnology-Derived Articles—Peptide Mapping <1055>, and Biotechnology-Derived Articles—Total Protein Assay <1057>.

Line 2 of paragraph 1 of Operational Qualification: Change
OQ demonstrates fitness for the selected use, and should reflect the contents of the DQ document.
to:
OQ demonstrates fitness for the selected use, and should reflect URS.
AND
Line 2 of paragraph 3 of Operational Qualification/Instrument Function Tests: Change
Holistic tests, which involve the entire system, demonstrate that the whole system complies with user specifications in the DQ.
to:
Holistic tests, which involve the entire system, demonstrate that the whole system complies with URS.

In 4.1 Documentation and Procedures/4.1.3 Labels: Change
The use of symbols that are recognized by international organizations is strongly recommended.
to:
The use of symbols that are recognized by international organizations is strongly recommended. See General Notices, 10.20. Labeling.

In paragraph 2 of 2.4 Study Design/2.4.1 Time Points: Change
Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution 〈1090〉.
to:
Assessment of Solid Oral Drug Product Performance and Interchangeability, Bioavailability, Bioequivalence, and Dissolution 〈1090〉.

Product column: Change
10.00 (neat), 5.00, 2.50, 1.25, 0.63, 0.31, 0.16
to:
10.00 (neat), 5.00, 2.50, 1.25, 0.625, 0.3125, 0.15625
AND
Sample 1/HCP ratio column: Change
4.9, 5.7, 4.8, 5.9, 5.0, 5.1, <6
to:
4.90, 5.70, 4.80, 5.92, 4.96, 5.12, <6
AND
Sample 2/HCP ratio column: Change
2.0, 3.3, 4.0, 5.9, 5.3, 6.1, <6
to:
2.00, 3.30, 4.00, 5.92, 5.28, 6.08, <6
AND
Sample 3/HCP ratio column: Change
0.3, 0.5, 0.6, 0.9, 1.4, <6, <6
to:
0.32, 0.50, 0.60, 0.88, 1.44, <6, <6
AND
Sample 3/% max ratio value column: Change
83%
to:
61%

In 10.2 Algebra Method/10.2.1 Calculating by using the algebra method/Examples—Algebra method:
In example 2, in equations 1, 2, 3, and 4 in all instances: Change
C_s
to:
Q_s
AND
In example 2, in equation 5: Change
C_w
to:
Q_w

In 19.4 Example Calculations of MKT for CRT Storage Evaluation/Example 3—Calculation of Annual MKTStep 3: Change
3.354
to:
3.340
AND
In Step 4: Change
2.795
to:
2.783
AND
In Step 5: Change
−33.511
to:
−33.515
AND
In Step 6: Change
298.410
to:
298.372

In the variable definition list: Change
T_n = value for the total number of storage temperatures recorded during the observation period temperature recorded during the nth time period, e.g., nth week
to:
T_n = value for the temperature recorded during the nth time period, e.g., nth week

Footnote 2: Change
http://whqlibdoc.who.int/trs/WHO_TRS_917_annex2.pdf (Accessed June 30, 2011)
to:
http://who.int/medicines/areas/quality_safety/quality_assurance/GoodtradeDistributionPracticesTRS917Annex2.pdf?ua=1 (Accessed March 2, 2015)

Footnote 11: Delete
http://www.fda.gov/ForIndustry/ImportProgram/AdmissibilityDeterminationsforShipmentsofForeign-originOASIS/ucm077691.htm (Accessed June 6, 2011).

Line 4 of paragraph 3 of 3.2 Combined Validation of Accuracy and Precision: Change
validate evaluate
to:
validate
AND
Variable definition in paragraph 6 of 3.2 Combined Validation of Accuracy and Precision: Change
Z²(1 + P)/2 = standard normal
to:
Z²(1 + P)/2 = the square of the standard normal

In Standard stock solution: Change
of USP Insulin RS of the appropriate species
to:
of the USP Insulin Reference Standard of the appropriate species
AND
In Sample stock solution: Change
of USP Insulin RS of the appropriate species.
to:
of the USP Insulin Reference Standard of the appropriate species.

Line 1 of Medium B: Change
Kreb's salt solution containing 0.3% (v/v) human serum albumen
to:
Krebs' salt solution containing 0.3% (v/v) human serum albumin
AND
Line 1 of Medium C: change
Kreb's salt solution containing 0.3% (v/v) human serum albumen
to:
Krebs' salt solution containing 0.3% (v/v) human serum albumin