This index was originally prepared as a poster presented at the 1995 Society of Quality Assurance annual meeting in Phoenix, AZ. The authors are members of the Quality Assurance Unit of Ricerca, Inc., 7528 Auburn Rd., Painesville, OH 44077-1000, (216) 357-3265.

This index has been reprinted and modified for the internet with permission of the authors by Michael E. Mispagel, The University of Georgia, College of Veterinary Medicine, Athens, GA 30602-7371, (706) 542-5875.

Sources for Food and Drug Administration and Environmental Protection Agency listings are from Society of Quality Assurance Regulatory Review Bulletins (RRB), no. 1 (January 1991) through no. 5 (September 30, 1994 (printed as 1995)) and the Regulatory Affairs Q&A column in the SQA Newsletter, Quality Assurance, vol. 2, no. 1 (April 1986) through vol. 10, no. 2 (Summer 1995). The electronic reprinting of these SQA documents is by express permission of the Society of Quality Assurance Board of Directors.

The reference from the SQA Newsletter is listed by volume, number, and date (example: Vol. 9, No. 2, June 1994). Reference from the Regulatory Review Bulletins (RRB) is listed as RRB number and date (example: RRB 3 Oct. 29, 1993).

Click here for the EPA topic index starting midway in this document.

Animal Identification

Animal Welfare (USDA) interactions

Archiving

Characterization of Test, Control, and Reference Substances

Cleaning Products

Clinical Quality Assurance - RRB 3 Oct. 29, 1993

Computers and Computer Validation

Container Labeling Requirements - Vol. 6, No. 4, Dec. 1991

Contractor/Sponsor Interactions - RRB 3 Oct. 29, 1993

CVM Inspection Program - RRB 3 Oct. 29, 1993

Data Verification

Definitions

Environmental Assessment Studies

Exact Copies

Extracted Test Article Solution Used as Test Article - Vol. 6, No. 2, June 1991

Facility Data

Final Report

Fraud Policy - RRB 3 Oct. 29, 1993

FDA 483s - RRB 3 Oct. 29, 1993

FDA Laboratories

Good Academic Research Practices Draft Guideline - RRB 3 Oct. 29, 1993

GMP Definition of Reagent/Finished Product Reagent for Medical Device - Vol. 5, No. 4, Dec. 1990

Immunotoxicology Guidelines/Nonavailability of Guideline - Vol. 4, No. 2, May 1989. And also here. - Vol. 6, No. 2, June 1991

Laboratory Environmental Records as Study Data - Vol. 5, No. 4, Dec. 1990

Master Schedule

Memoranda of Understanding (MOUs)

Physical and Chemical Characterization Studies to be in Full GLP Compliance - Vol. 6, No. 3, Sept. 1991

Protocol

Protocol Changes

Protocol Signature

Quality Assurance (QAU)

QAU Records

Raw Data Corrections

Reagent Labeling

Record Retention

Report Amendments

Reserve Samples

Scope of Good Laboratory Practice Regulations (GLPR)

Society of Quality Assurance (SQA)

Specimens

Study Director

Test Article

Test Substance (Article) Containers

Vendor Audits - RRB 3 Oct. 29, 1993

Accreditation/Certification of Laboratories - RRB 5 Sept. 30, 1995

Aerial Application

Agency

Archiving

Calibration

Characterization

Computer Validation

Definition

Efficacy Study Compliance Status - RRB 5 Sept. 30, 1995

EPA Inspections

EPA Inspectors

Equipment and other Facility Records

Experimental Termination Date - RRB 5 Sept. 30, 1995

Facility Data

Facility Inspections

Final Report

Freedom of Information (FOI) system - Vol. 9, No. 2, June 1994

GALPs (Good Automated Laboratory Practices) - RRB 5 Sept. 30, 1995. And

• also here - Vol. 10, No. 2, Summer 1995.

To go to the EPA Home Page and the complete text of the GALPs, click here.

GLP Compliance Statement

• Amended compliance statement - Vol. 9, No. 1, March 1994. And, also here - RRB 5 Sept. 30, 1995.
• For amended report - Vol. 9, No. 1, March 1994
• Measurements, physical observations - Vol. 9, No. 2, June 1994
• PR Notice 86-5 (and revision) - RRB 3 Dec. 10, 1993
• "To the best of" cause for study rejection - RRB 3 Dec. 10, 1993
• Will reporting deviations from GLP result in compliance (legal) action? - Vol. 5, No. 1, March 1990

GLPS and field studies - RRB 3 Dec. 10, 1993

GLP Deviations - RRB 3 Dec. 10, 1993

Harmonization of GLPs

• EPA with OECD - RRB 5 Sept. 30, 1995

Industry Response

• What can sponsor, contract facilities, third party management, and QA do to improve compliance programs? - RRB 5 Sept. 30, 1995

Inspection Manual for Field Studies - RRB 1 Jan. 1991

Inspection Report Findings - RRB 1 Jan. 1991. And, also here - RRB 3 Dec. 10, 1993.

• No '483-type' form expected - RRB 1 Jan. 1991. And, also here - RRB 3 Dec. 10, 1993.
• Relative to enforcement actions - RRB 3 Dec. 10, 1993

Inspector Training Program - RRB 1 Jan. 1991

Laboratory Accreditation - RRB 3 Dec. 10, 1993

Laboratory Certification - German Requirement - RRB 3 Dec. 10, 1993

Manufacturing

• Do GLPs apply to routine manufacture? - Vol. 5, No. 2, June 1990

Master Schedule

• Purpose of listing - Vol. 5, No. 2, June 1990

Mechanism for Dissemination of EPA Policy - RRB 1 Jan. 1991

• Q & A Document - RRB 1 Jan. 1991

MOUs as basis for non-U.S. submissions under EPA GLPS - RRB 5 Sept. 30, 1995

Normal Agronomic Practice and GLP Compliance - RRB 3 Dec. 10, 1993

Organization and Personnel

• Adequacy of QAU, scientific personnel - RRB 3 Dec. 10, 1993
• Job description content requirements - RRB 3 Dec. 10, 1993
• Maintenance staff as study personnel? - Vol. 9, No. 2, June 1994

Product Performance

• Data - RRB 1 Jan. 1991
• Studies and GLP - RRB 3 Dec. 10, 1993

Protocol

• Amendment and deviation handling - Vol. 9, No. 2, June 1994
• Availability to all participants - RRB 3 Dec. 10, 1993
  • Soil characterization clarification - RRB 3 Dec. 10, 1993
• Can multiple test articles be applied under one study? - Vol. 5, No. 1, March 1990. And, also here - Vol. 5, No. 3, Sept. 1990.
• Confidentiality issues - RRB 3 Dec. 10, 1993
• Deviations and the compliance statement - RRB 3 Dec. 10, 1993. And, also here- Vol. 9, No. 1, March 1994.
• Location relative to QAU and study director - RRB 5 Sept. 30, 1995
• Measurements, physical observations - Vol. 9, No. 2, June 1994
• Protocol approval - RRB 5 Sept. 30. 1995
• Signing of protocol by other parties - RRB 5 Sept. 30, 1995
• Amendment requires only study director signing - RRB 5 Sept. 30, 1995
• SOP deviations written as protocol deviations - Vol. 9, No. 2, June 1994
• Test system (transplant or seed) records - Vol. 9, No. 2, June 1994

Quality Assurance (QAU)

• Audit copies/original - Vol. 9, No. 2, June 1994
• Independence and separateness - RRB 3 Dec. 10, 1993
• Inspection frequency for a study - Vol. 5, No. 1, March 1990
• Inspectional frequency/minimum - RRB 5 Sept. 30, 1995
• Inspection of some short term studies - Vol. 5, No. 2, June 1990
• Involvement in specimen disposition - RRB 5 Sept. 30, 1995
• Non study specific procedure inspection - Vol. 9, No. 1, March 1994
• Protocol review including scientific issues - RRB 3 Dec. 10, 1993
• Reporting to study director also in management role - RRB 3 Dec. 10, 1993. And, also here - RRB 5 Sept. 30, 1995.
• Reporting to study director/management - RRB 3 Dec. 10, 1993
• Key parties to be kept informed - RRB 3 Dec. 10, 1993
• Retention of proof review - RRB 5 Sept. 30, 1995
• Routing of QA audit report copies to both management and study director - RRB 5 Sept. 30, 1995
• Routing of QA audit reports to intermediate - RRB 5 Sept. 30, 1995
• When sponsor does part of study - RRB 5 Sept. 30, 1995

Quality Assurance Verification - Vol. 5, No. 1, March 1990

Raw Data

• Entry required for each measured sample - RRB 5 Sept. 30, 1995
• Hand-entry requires authentic initials and date - RRB 5 Sept. 30, 1995
• Use of preprinted forms and need for authentic initials, dates - RRB 5 Sept. 30, 1995

Record Retention Requirements - RRB 1 Jan. 1991

• Amended report - Vol. 9, No. 1, March 1994
• Difference between FIFRA and TSCA - RRB 1 Jan. 1991
• Record and Sample - Vol. 5, No. 2, June 1990
• Test system records per protocol - Vol. 9, No. 2, June 1994

Reporting of Selected Data - RRB 3 Dec. 10, 1993

Reserve Samples

• Clarify the "4 weeks" in 40 CFR 160.105 - Vol. 3, No. 4, May 1988

Residue Studies

• Is water analysis required? - Vol. 5, No. 1, March 1990

Sample (Specimen) Retention

• Degradation and discarding dates to be recorded - RRB 5 Sept. 30, 1995
• In nontoxicological studies - RRB 1 Jan. 1991

Solubility Studies

• Is 160.135(a) applicable to organic solubility studies? - Vol. 5, No. 1, March 1990

Standard Operating Procedures (SOPs)

Availability

• Electronic access - RRB 3 Dec. 10, 1993
• Documentation of SOP deviation with the raw data - Vol. 9, No. 2, June 1994
• Individuals authorizing deviations - Vol. 5, No. 1, March 1990
• Required for equipment which can malfunction/affect study integrity - Vol. 9, No. 1, March 1994

Study Director

• Absences, accessibility - RRB 5 Sept. 30, 1995
• Multiple site studies - Vol. 5, No. 2, June 1990
• Multiple study directors - Vol. 5, No. 1, March 1990
• Protocol not to specify QAU inspectional activities - RRB 3 Dec. 10, 1993
• Relationship with QAU - RRB 3 Dec. 10, 1993
• Signing of final report by surrogate - Vol. 9, No. 2, June 1994

Submissions

• Copies of field notebook or summaries of data - Vol. 5 , No. 2, June 1990

Surfactant

• In spray mixtures what documentation is needed? - Vol. 5, No. 1, March 1990

Test, Control and Reference Substances

• Commercial supplier for control or reference substances - RRB 5 Sept. 30, 1995
• Container exemption - Vol. 5, No. 1, March 1990
• Container retention - Vol. 5, No. 1, March 1990
• Location for documentation of synthesis method - RRB 5 Sept. 30, 1995
• Multiple substances - RRB 3 Dec. 10, 1993
• GLP implication of one test substance/one final report - RRB 3 Dec. 10, 1993
• Periodic analyses of (typical) tank mixes - RRB 5 Sept. 30, 1995
• Reference substances - RRB 5 Sept. 30, 1995
  • Study director decision for reanalysis - RRB 5 Sept. 30, 1995
• Retention of empty containers - RRB 3 Dec. 10, 1993
• Stability and homogeneity requirements
  • For "acute" studies - RRB 3 Dec. 10, 1993
  • For tank mix admixing of maintenance chemicals with test substances - RRB 3 Dec. 10, 1993

Testing Facility Management

• Participative oversight encouraged by EPA - Vol. 9, No. 2, June 1994

Test System Identification

• Field site plot - Vol. 9, No. 2, June 1994

Third Party Contractor (or Subcontractor) Reports - RRB 3 Dec. 10, 1993

TSCA Section 5/GLP Compliance Statement - RRB 1 Jan. 1991

Click here to go back to top of EPA Topic Index or here to go back to top of FDA Topic Index.

Or click here to go to an Index of Titles of these documents.

[Regulatory Review Bulletin #5 (EPA/SQA RRC Meeting July 21, 1994) dated September 30, 1995 was issued ca. September 30, 1994.]

[Q and A synopsis of a NACA/FIFRA GLP Workshop by Patrick O. Jones included in SQA Newsletter Volume 5, No. 1, dated March 1990.]

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