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" Lot means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process... "
Competitive Problems in the Drug Industry - 8341. lappuse
autors: United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1971
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Code of Federal Regulations: Containing a Codification of Documents of ...

1997 - 200 lapas
...or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. (11) Lot number, control number, or batch...
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Hearings, Reports and Prints of the Senate Select Committee on ..., 20-22. daļas

United States. Congress. Senate. Select Committee on Small Business - 1971 - 1192 lapas
...for manufacturing use in the production of a medicated feed. Medicated premixes are subject to S§ 133.200-133.210, inclusive. (d) As used in §§ 133.2-133.15,...has uniform character and quality within specified limit*. (4) The terms "lot number" or "control number" mean any distinctive combination of letters...
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Validation Compliance Annual: 1995

International Validation Forum - 1995 - 1114 lapas
...or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. (11) Lot number, control number, or batch...
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Strauss' Pharmacy Law and Examination Review, Fifth Edition

Steven Strauss - 2000 - 454 lapas
...or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. 21 CFR210.3IJK1DI Lot Number a distinctive...
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Validation Standard Operating Procedures: A Step by Step Guide for Achieving ...

Syed Imtiaz Haider - 2001 - 498 lapas
...or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. §211.48 Plumbing (a) Potable water shall...
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Pharmaceutical Quality Control Lab Guidebook

Daniel Farb, Anthony Luttrell, Robert Kirsch - 2005 - 100 lapas
...or, in the case of a drug product, produced by continuous process. It is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. Measurement - Individual replicate value...
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Pharmaceutical Computer Validation Introduction Guidebook

Daniel Farb, Bruce Gordon - 2005 - 116 lapas
...or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. (11) Lot number, control number, or batch...
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Part 11 and Computer Validation Guidebook

Daniel Farb, Bruce Gordon - 2005 - 329 lapas
...or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. (11) Lot number, control number, or batch...
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Validating Chromatographic Methods: A Practical Guide

David M. Bliesner - 2006 - 354 lapas
...limits or, in the case of a drug product, is a continuous process; it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. Master production record. A document...
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Establishing A CGMP Laboratory Audit System: A Practical Guide

David M. Bliesner - 2006 - 384 lapas
...limits, or in the case of a drug product, a continuous process. It is a specific identified amount produced in a unit of time or quantity in a manner that assures uniform character and quality, within specified limits. Master Production Record A document that specifies...
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