International labeling requirements for medical devices, medical equipment, and diagnostic equipment part 3





Cleaning validation

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Cleaning validation / No. 5-285-890 (2000)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Managing the analytical laboratory: plain and simple

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Managing the analytical laboratory: plain and simple / No. 4-240-470 (1996)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Master keyword guide to 21 CFR food and drug

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Master keyword guide to 21 CFR food and drug / No. 3-008-687 (1990)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Metered dose inhaler technology

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Metered dose inhaler technology / No. 4-730-259 (1998)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Microbial limit and bioburden tests: validation approaches and global requirements

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Microbial limit and bioburden tests: validation approaches and global requirements / No. 4-712-262 (1998)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Pharmaceutical applications in the European Union

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Pharmaceutical applications in the European Union; a guide through the regulations maze / No. 4-724-184 (1998)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Pharmaceutical manufacturing change control

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Pharmaceutical manufacturing change control / No. 5-296-485 (2000)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Pharmaceutical marketing

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Pharmaceutical marketing; a practical guide / No. 5-454-077 (2001)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Pharmaceutical quality systems

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Pharmaceutical quality systems / No. 5-285-819 (2000)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Pharmaceutical unit operations--coating

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Pharmaceutical unit operations--coating / No. 4-866-455 (1998)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Pharmaceutical water: system design, operation, and validation

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Pharmaceutical water: system design, operation, and validation / No. 4-864-583 (1998)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Physician investigator handbook--GCP tools and techniques

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Physician investigator handbook--GCP tools and techniques / No. 4-558-611 (1997)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Physician investigator handbook--GCP tools and techniques

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Physician investigator handbook--GCP tools and techniques / 2nd ed. No. 5-562-748 (2002)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Predictor

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Predictor / No. 3-089-291 (1990)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Pre-production quality assurance for healthcare manufacturers

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Pre-production quality assurance for healthcare manufacturers / No. 4-608-136 (1997)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Reg-words keyword guide to drug GMPs

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Reg-words keyword guide to drug GMPs / No. 291-342 (1979)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Reg-words keyword guide to good laboratory practices GLPs

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Reg-words keyword guide to good laboratory practices GLPs / No. 291-023 (1979)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Reg-words keyword guide to medical device GMPs

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Reg-words keyword guide to medical device GMPs / No. 291-024 (1979)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Reg-words keyword guide to parenteral GMPs

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Reg-words keyword guide to parenteral GMPs / No. 289-508 (1979)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Safety in electromedical technology

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Safety in electromedical technology / No. 4-326-478 (1996)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Separations technology: pharmaceutical and biotechnology applications

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Separations technology: pharmaceutical and biotechnology applications / No. 4-129-018 (1995)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Sterile pharmaceutical manufacturing, vol. 1

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Sterile pharmaceutical manufacturing, vol. 1 / No. 3-058-916 (1991)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Cleaning validation

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005285890 / 2000-10-16
Date of Publication:
January 3, 2000
Date of Creation:
2000
Title:
Cleaning validation : a practical approach / Gil Bismuth and Shosh Neumann.
Imprint:
Denver : Interpharm Press, c2000.
Description:
186 p.
Variant title:
Cleaning validation : a practical approach
Copyright Claimant:
Interpharm Press, Inc.
Names:
Gil Bismuth 1942-
Shosh Neumann 1955-
Interpharm Press, Inc. (79 documents)
example document: EPA-speak

Copyrights records by Interpharm Press, Inc.



Cleaning validation

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006449363 / 2006-10-06
Date of Publication:
September 25, 2006
Date of Creation:
2006
Title:
Cleaning validation : practical compliance solutions for pharmaceutical manufacturing.
Rights and Permissions:
Rights & permissions info. on original appl. in C.O.
Copyright Note:
Cataloged from appl. only.
Copyright Claimant:
Destin A. LeBlanc
Names:
Destin A. LeBlanc

Cleaning validation for removable valves non-sterile systems only

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TXu000588849 / 1993-08-23
Date of Creation:
1993
Title:
Cleaning validation for removable valves non-sterile systems only.
Description:
1 v.
Copyright Claimant:
Cora International, Inc.
Names:
Cora International, Inc.

Cleaning validation for clean-in-place (CIP) systems non-sterile systems only

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TXu000588851 / 1993-08-23
Date of Creation:
1993
Title:
Cleaning validation for clean-in-place (CIP) systems non-sterile systems only.
Description:
1 v.
Copyright Claimant:
Cora International, Inc.
Names:
Cora International, Inc.

Cleaning validation Sarong Suppository Machine

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TXu000606311 / 1993-10-15
Date of Creation:
1993
Title:
Cleaning validation Sarong Suppository Machine.
Copyright Note:
C.O. correspondence.
Description:
1 v..
Copyright Claimant:
Key International, Inc.
Authorship on Application:
text & compilation: Key International, Inc.
Names:
Key International, Inc.

Copyrights records by Key International, Inc.



Cleaning validation

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TXu000606441 / 1993-12-29
Date of Creation:
1993
Title:
Cleaning validation : Frewitt SG turbo sieve.
Description:
1 v.
Variant title:
Cleaning validation : Frewitt SG turbo sieve
Copyright Claimant:
Key International, Inc.
Names:
Key International, Inc.

Cleaning validation Frewitt oscillating granulator

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TXu000611670 / 1993-10-15
Date of Creation:
1993
Title:
Cleaning validation Frewitt oscillating granulator.
Copyright Note:
C.O. correspondence.
Description:
1 v.
Copyright Claimant:
Key International, Inc.
Notes:
Text.
Names:
Key International, Inc.

Cleaning validation

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TXu000620922 / 1994-02-22
Date of Creation:
1994
Title:
Cleaning validation : Tonazzi tube filling and sealing machine.
Description:
Sheets.
Variant title:
Cleaning validation : Tonazzi tube filling and sealing machine
Copyright Claimant:
Key International, Inc.
Names:
Key International, Inc.

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