ISPE Baseline pharmaceutical engineering guide, Vol. 1: active pharmaceutical ingredients



GAMP, good automated manufacturing practice

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004171734 / 1995-07-03
Date of Publication:
January 10, 1995
Date of Creation:
1995
Title:
GAMP, good automated manufacturing practice : Supplier guide for validation of automated systems in pharmaceutical manufacture.
Edition:
2nd draft.
Basis of Claim:
New Matter: compilation, additions & editing.
Copyright Note:
C.O. correspondence.
Description:
1 v.
Other Title:
Supplier guide for validation of automated systems in pharmaceutical manufacture
Copyright Claimant:
International Society for Pharmaceutical Engineering
Authorship on Application:
UK Pharmaceutical Industry Computer Systems Validation Forum (employer for hire)
Names:
International Society for Pharmaceutical Engineering
UK Pharmaceutical Industry Computer Systems Validation Forum

GAMP supplier guide for validation of automated systems in pharmaceutical manufacture

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004367216 / 1996-09-05
Date of Publication:
May 15, 1996
Date of Creation:
1996
Title:
GAMP supplier guide for validation of automated systems in pharmaceutical manufacture.
Basis of Claim:
New Matter: revisions & additions.
Previous Registration:
Prev. reg. 1995, TX 4-171-734.
Description:
1 v.
Other Title:
GAMP, good automated manufacturing practice: supplier guide for validation of automated systems
Copyright Claimant:
International Society for Pharmaceutical Engineering
Notes:
Spine ti.: GAMP, good automated manufacturing practice: supplier guide for validation of automated systems in pharmaceutical manufacture.
Names:
International Society for Pharmaceutical Engineering

GAMP guide for validation of automated systems in pharmaceutical manufacture

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005079812 / 1999-10-14
Date of Publication:
March 1, 1998
Date of Creation:
1998
Title:
GAMP guide for validation of automated systems in pharmaceutical manufacture : vol. 2, best practice for users and suppliers.
Basis of Claim:
New Matter: revisions & additions.
Previous Registration:
Prev. reg. as GAMP 96 supplier guide (version 2.0), 1996, TX 4-367-216.
Copyright Note:
C.O. correspondence.
Description:
1 v.
Variant title:
GAMP guide for validation of automated systems in pharmaceutical manufacture : vol. 2
Other Title:
GAMP 96 supplier guide (version 2.0)
Copyright Claimant:
International Society for Pharmaceutical Engineering
Authorship on Application:
GAMP Forum, employer for hire.
Names:
International Society for Pharmaceutical Engineering
GAMP Forum

Copyrights records by GAMP Forum

GAMP guide for validation of automated systems in pharmaceutical manufacture

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005079813 / 1999-10-14
Date of Publication:
March 1, 1998
Date of Creation:
1998
Title:
GAMP guide for validation of automated systems in pharmaceutical manufacture : vol. 1, pts. 1-2.
Application Title:
GAMP 3: vol. 2.
Basis of Claim:
New Matter: revisions & additions.
Previous Registration:
Prev. reg. as GAMP 96 supplier guide (version 2.0), 1996, TX 4-367-216.
Copyright Note:
C.O. correspondence.
Description:
2 v.
Variant title:
GAMP guide for validation of automated systems in pharmaceutical manufacture : vol. 1, pts. 1-2
Other Title:
GAMP 3: vol. 2
GAMP 96 supplier guide (version 2.0)
Copyright Claimant:
International Society for Pharmaceutical Engineering
Authorship on Application:
GAMP Forum, employer for hire.
Names:
GAMP Forum
International Society for Pharmaceutical Engineering

GAMP good practice guide

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005500088 / 2002-03-13
Date of Publication:
January 31, 2002
Date of Creation:
2002
Title:
GAMP good practice guide : calibration management.
Description:
1 v.
Variant title:
GAMP good practice guide : calibration management
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Authorship on Application:
GAMP Forum, employer for hire.
Names:
International Society for Pharmaceutical Engineering, Inc.

Copyrights records by International Society for Pharmaceutical Engineering, Inc.

ISPE

Copyrights records by ISPE

GAMP Forum

GAMP guide for validation of automated systems

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005500101 / 2002-03-13
Date of Publication:
November 19, 2001
Date of Creation:
2001
Title:
GAMP guide for validation of automated systems : GAMP 4.
Basis of Claim:
New Matter: revision & new content.
Previous Registration:
Prev. reg. 1999, TX 5-079-812 & 2000, TX 5-079-813, as GAMP guide for validation of automated systems in pharmaceutical manufacture, GAMP 3, vol. 1-2.
Imprint:
Tampa : ISPE, c2001.
Description:
1 v.
Other Title:
GAMP guide for validation of automated systems in pharmaceutical manufacture, GAMP 3, vol. 1-2
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Authorship on Application:
GAMP Forum, employer for hire.
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE
GAMP Forum

ISPE good practice guide

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005952608 / 2004-03-26
Date of Publication:
March 25, 2003
Date of Creation:
2003
Title:
ISPE good practice guide : technology transfer.
Imprint:
Tampa : ISPE, c2003.
Description:
124 p.
Variant title:
ISPE good practice guide : technology transfer
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE

Sterile manufacturing facilties

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005956956 / 2004-03-26
Date of Publication:
January 15, 1999
Date of Creation:
1999
Title:
Sterile manufacturing facilties.
Edition:
1st ed.
Series:
Baseline pharmaceutical engineering guide ; v. 3
Imprint:
Tampa : ISPE, 1999.
Description:
162 p.
Other Title:
Baseline pharmaceutical engineering guide ; v. 3
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE

Oral solid dosage forms

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005956957 / 2004-03-26
Date of Publication:
February 15, 1998
Date of Creation:
1998
Title:
Oral solid dosage forms.
Edition:
1st ed.
Series:
Baseline pharmaceutical engineering guide ; v. 2
Imprint:
Tampa : ISPE, 1998.
Description:
81 p.
Other Title:
Baseline pharmaceutical engineering guide ; v. 2
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE

Water and steam systems

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005956958 / 2004-03-26
Date of Publication:
January 15, 2001
Date of Creation:
2001
Title:
Water and steam systems.
Edition:
1st ed.
Series:
Baseline pharmaceutical engineering guide ; v. 4
Imprint:
Tampa : ISPE, 2001.
Description:
223p.
Other Title:
Baseline pharmaceutical engineering guide ; v. 4
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE

GAMP good practice guide

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005957007 / 2004-03-26
Date of Publication:
October 31, 2003
Date of Creation:
2003
Title:
GAMP good practice guide : validation of process control systems.
Imprint:
Tampa : ISPE, c2003.
Description:
1 v.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Authorship on Application:
GAMP Forum, employer for hire.
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE
GAMP Forum

ISPE good practice guide

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006233947 / 2005-09-02
Date of Publication:
January 14, 2005
Date of Creation:
2005
Title:
ISPE good practice guide : assessing the particulate containment performance of pharmaceutical equipment.
Copyright Note:
Cataloged from appl. only.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Authorship on Application:
SMEPAC Committee, employer for hire.
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE
SMEPAC Committee

Baseline pharmaceutical enginnering guide

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006246324 / 2005-09-12
Date of Publication:
August 8, 2004
Date of Creation:
2004
Title:
Baseline pharmaceutical enginnering guide : vol. 6, Biopharmaceutical manufacturing facilities.
Copyright Note:
Cataloged from appl. only.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. ISPE
Authorship on Application:
ISPE Biopharmaceutical Manufacturing Facilities Task Team, employer for hire.
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE
ISPE Biopharmaceutical Manufacturing Facilities Task Team

GAMP good practice guide

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006256629 / 2005-09-20
Date of Publication:
February 11, 2005
Date of Creation:
2005
Title:
GAMP good practice guide : a risk-based approach to compliant electronic records and signatures.
Previous Registration:
Some text is preexisting.
Copyright Note:
Cataloged from appl. only.
Other Title:
International Society for Pharmaceutical Engineering, Inc.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Authorship on Application:
GAMP Forum, employer for hire.
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE
GAMP Forum

GAMP good practice guide

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006256796 / 2005-10-03
Date of Publication:
April 12, 2005
Date of Creation:
2005
Title:
GAMP good practice guide : validation of laboratory computerized systems.
Copyright Note:
Cataloged from appl. only.
Other Title:
International Society for Pharmaceutical Engineering, Inc.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Authorship on Application:
GAMP Forum, employer for hire.
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE
GAMP Forum

GAMP good practice guide

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006323288 / 2006-01-25
Date of Publication:
November 3, 2005
Date of Creation:
2005
Title:
GAMP good practice guide : global information systems control and compliance.
Imprint:
Tampa : ISPE, c2005.
Description:
1 v.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc.
Authorship on Application:
GAMP Forum, employer for hire.
Names:
International Society for Pharmaceutical Engineering, Inc.
GAMP Forum

GAMP good practice guide

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006326655 / 2006-02-16
Date of Publication:
December 20, 2005
Date of Creation:
2005
Title:
GAMP good practice guide : testing of GxP systems.
Copyright Note:
Cataloged from appl. only.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Authorship on Application:
GAMP Forum, employer for hire.
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE)
GAMP Forum

ISPE.ORG web site

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006348240 / 2005-10-04
Date of Publication:
June 20, 2003
Date of Creation:
2005
Title:
ISPE.ORG web site.
Copyright Note:
Cataloged from appl. only.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc.
Names:
International Society for Pharmaceutical Engineering, Inc.

Pharmaceutical Engineering

Title:
Pharmaceutical Engineering : the official journal of the International Society of Pharmaceutical Engineers.
Serial Publication Year:
2000
Serial Key Title:
Pharmaceutical Engineering
Imprint:
Tampa : ISPE.
ISSN:
0273-8139

Description:
print material.
Frequency:
Bimonthly.
Description based on:
Vol. 8, no. 1, Jan./Feb. 1988.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. ISPE)
Names:
ISPE
International Society for Pharmaceutical Engineering, Inc.

Pharmaceutical Engineering

Title:
Pharmaceutical Engineering : the official journal of the International Society of Pharmaceutical Engineers.
Serial Publication Year:
2005
Serial Key Title:
Pharmaceutical Engineering
Imprint:
Tampa : ISPE.
ISSN:
0273-8139

Description:
print material.
Frequency:
Bimonthly.
Description based on:
Vol. 8, no. 1, Jan./Feb. 1988.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. ISPE)
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE

Pharmaceutical Engineering

Title:
Pharmaceutical Engineering : the official journal of the International Society of Pharmaceutical Engineers.
Serial Publication Year:
1995
Serial Key Title:
Pharmaceutical Engineering
Imprint:
Tampa : ISPE.
ISSN:
0273-8139

Description:
print material.
Frequency:
Bimonthly.
Description based on:
Vol. 8, no. 1, Jan./Feb. 1988.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc.
Names:
International Society for Pharmaceutical Engineering, Inc.

ISPEAK

Title:
ISPEAK : news for and about ISPE members.
Serial Publication Year:
2002
Description:
print material.
Frequency:
Bimonthly.
Variant title:
ISPEAK newsletter.
Description based on:
Vol. 20, no. 2, Mar. 2000.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. ISPE)
Names:
ISPE
International Society for Pharmaceutical Engineering, Inc.

ISPEAK

Title:
ISPEAK : news for and about ISPE members.
Serial Publication Year:
2003
Description:
print material.
Frequency:
Bimonthly.
Variant title:
ISPEAK newsletter.
Description based on:
Vol. 20, no. 2, Mar. 2000.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. ISPE)
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE

ISPE good practice guide

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006585582 / 2007-03-16
Date of Publication:
February 8, 2007
Date of Creation:
2007
Title:
ISPE good practice guide : commissioning and qualification of pharmaceutical water and steam systems.
Copyright Note:
Cataloged from appl. only.
Other Title:
International Society for Pharmaceutical Engineering, Inc. good practice guide : commissioning and qualification
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc. (Tampa, FL) (ISPE)
Names:
International Society for Pharmaceutical Engineering, Inc. (Tampa, FL)
ISPE

ISPE Baseline pharmaceutical engineering guide, Vol. 1: active pharmaceutical ingredients

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006584839 / 2007-06-04
Date of Publication:
May 23, 2007
Date of Creation:
2007
Title:
ISPE Baseline pharmaceutical engineering guide, Vol. 1: active pharmaceutical ingredients.
Edition:
2nd. ed.
Basis of Claim:
New Matter: additions and revisions.
Previous Registration:
Prev. reg.: 2004, TX 5-956-948.
Copyright Note:
Cataloged from appl. only.
Copyright Claimant:
International Society for Pharmaceutical Engineering, Inc.
Authorship on Application:
ISPE
Names:
International Society for Pharmaceutical Engineering, Inc.
ISPE
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