Compliance auditing for pharmaceutical manufacturers: a practical guide to in-depth systems auditing





Automated microbial identification and quantitation

Document number:
V3498D984
Date of Recordation:
June 21, 2003
Entire Copyright Document:
V3498 D984 P1-17
Title:
Automated microbial identification and quantitation / No. 4-284-233 (1996)
Number of similar titles:
1
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Automated microbial identification and quantitation

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Automated microbial identification and quantitation / No. 4-284-233 (1996)
Number of similar titles:
1
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Cleanroom microbiology for the non-microbiologist

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Cleanroom microbiology for the non-microbiologist / No. 4-084-612 (1995)
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3
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Clinical development: strategic, pre-clinical, clinical, and regulatory issues

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Clinical development: strategic, pre-clinical, clinical, and regulatory issues / No. 5-454-076 (2001)
Number of similar titles:
1
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Code of Federal regulations, Title 21, part 58, good laboratory practices

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Code of Federal regulations, Title 21, part 58, good laboratory practices / No. 1-030-003 (2002)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Code of federal regulations, Title 21, part 606, biological and blood products GMPs

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Code of federal regulations, Title 21, part 606, biological and blood products GMPs / No. 1-030-004 (2002)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Code of federal regulations, Title 21, parts 210 and 211, pharmaceutical and bulk chemical GMPS

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Code of federal regulations, Title 21, parts 210 and 211, pharmaceutical and bulk chemical GMPS / No. 1-030-002 (2002)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Compact regs good clinical practices (GCP), code of federal regulations

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Compact regs good clinical practices (GCP), code of federal regulations / No. 4-217-522 (1996)
Variant title:
Compact regs good clinical practices (GCP)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Compact regs good laboratory practices (GLP), code of federal regulations

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Compact regs good laboratory practices (GLP), code of federal regulations / No. 4-214-587 (1996)
Variant title:
Compact regs good laboratory practices (GLP)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Compact regs medical device and equipment GMPS

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Compact regs medical device and equipment GMPS; code of federal regulations / No. 4-222-093 (1996)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Compact regs pharmaceutical and bulk chemical GMPS

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Compact regs pharmaceutical and bulk chemical GMPS; code of federal regulations / No. 4-217-521 (1996)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Complaint handling: worldwide regulations for healthcare manufacturers

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Complaint handling: worldwide regulations for healthcare manufacturers / No. 4-369-957 (1996)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Control of particulate matter in healthcare manufacturing

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Control of particulate matter in healthcare manufacturing / No. 5-296-319 (2000)
Number of similar titles:
1
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Cryopreservation: applications in pharmaceuticals and biotechnology

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Cryopreservation: applications in pharmaceuticals and biotechnology / No. 5-285-820 (2000)
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1
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Data acquisition and measurement techniques

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Data acquisition and measurement techniques / No. 864-995 (1998)
Number of similar titles:
2
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Drug development programme management

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Drug development programme management / No. 5-299-948 (2000)
Number of similar titles:
2
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Drug regulation in African countries

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Drug regulation in African countries / No. 3-151-125 (1991)
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2
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

FDA inspections: a guide for medical device and diagnostic manufacturers

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
FDA inspections: a guide for medical device and diagnostic manufacturers / No. 4-547-211 (1997)
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1
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

FDA regulation of medical devices

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
FDA regulation of medical devices / No. 5-454-078 (2001)
Number of similar titles:
3
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

FDA-SPEAK, a glossary and agency guide

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
FDA-SPEAK, a glossary and agency guide / No. 5-603-501 (2002)
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

FDA-SPEAK--the interpharm glossary of acronyms and regulatory terms

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
FDA-SPEAK--the interpharm glossary of acronyms and regulatory terms.
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

Fluid sterilization by filtration

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
Fluid sterilization by filtration / 2nd ed. No. 4-547-212 (1997)
Number of similar titles:
4
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

GLP applications for test substance control, formulation, and analysis

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
GLP applications for test substance control, formulation, and analysis / No. 5-454-065 (2001)
Number of similar titles:
2
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

GLP essentials: a concise guide to good laboratory practice

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
GLP essentials: a concise guide to good laboratory practice / No. 4-074-540 (1995)
Number of similar titles:
2
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

GLP quality audit manual

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
GLP quality audit manual / 3rd ed. No. 5-287-643 (2000)
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2
Similar Title:
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

GLP/GMP computer procedures and systems

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
GLP/GMP computer procedures and systems / No. 3-663-002 (1995)
Number of similar titles:
2
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

How to apply quality assurance principles--facilitator's manual

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
How to apply quality assurance principles--facilitator's manual / (GMP training series) No. 4-086-310 (1996)
Number of similar titles:
1
Variant title:
GMP training series
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

How to apply quality assurance principles--student book

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
How to apply quality assurance principles--student book / (GMP training series) No. 4-264-613 (1996)
Number of similar titles:
1
Variant title:
GMP training series
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

How to organize a validation file--facilitator's manual

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
How to organize a validation file--facilitator's manual / (GMP training series) No. 4-235-931 (1996)
Number of similar titles:
1
Variant title:
GMP training series
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

How to organize a validation file--student book

Document number:
V3495D573
Date of Recordation:
March 24, 2003
Entire Copyright Document:
V3495 D573 P1-14
Title:
How to organize a validation file--student book / (GMP training series) No. 4-259-998 (1996)
Number of similar titles:
1
Variant title:
GMP training series
Title appears in Document:
A handbook of SOPs for GCP & 145 other titles.

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