DOXPUB

$50.00
2 to 8C Cold Room Installation Qualification Report Edition: 1.0 Doxpub, Inc. / 01-Aug-2004 / 5 pages An equipment validation report that describes the Conclusions and Recommendations of a successfully completed IQ Protocol for a built-in, walk-in refrigerator for storing GxP raw materials and finished products at a temperature range of 2 to 8 degrees C. Includes Results & Analysis sections for each data collection form identified in the IQ Protocol, 11-0042-IQP-1.0. See the OQ Protocol...
$160.00
2 to 8C Cold Room Installation Qualification Protocol Edition: 1.0 Doxpub, Inc. / 01-Aug-2004 / 16 pages An equipment validation protocol for assessing, verifying and documenting the installation and completeness of a built-in, walk-in refrigerator for storing GxP raw materials and finished products at a temperature range of 2 to 8 degrees C. Includes 11 data collection forms for Equipment, Materials in Product Contact, Procurement and Installation Records, Certification Documents, Equipment...
$140.00
2 to 8C Cold Room Operational Qualification Protocol Edition: 1.0 Doxpub, Inc. / 01-Aug-2004 / 14 pages An equipment validation protocol for evaluating procedures for monitoring, maintaining, cleaning and operating a built-in, walk-in refrigerator for storing GxP raw materials and finished products at a temperature range of 2 to 8 degrees C. Also includes functional verification of system components, including controls and alarms, and temperature mapping using a Kaye thermal validator....
$80.00
2 to 8C Cold Room Operational Qualification Report Edition: 1.0 Doxpub, Inc. / 01-Aug-2004 / 8 pages A validation report that describes the Conclusions and Recommendations of a successfully completed OQ Protocol for a built-in, walk-in refrigerator for storing GxP raw materials and finished products at a temperature range of 2 to 8 degrees C. Includes a Results & Analysis and a Discrepancies & Exceptions section for each data collection form identified in the OQ Protocol,...
$50.00
IOQ Report for the A&D Engineering Model FX-4000 Balance Edition: 1 Doxpub, Inc. / 01-Nov-2004 / 5 pages This document is an IOQ report that describes the Conclusions and Recommendations of a successfully completed protocol that qualifies the A&D; Engineering Model FX-4000 Balance for use in manufacturing product for clinical or commercial distribution. Includes Results & Analysis sections for each test identified in the IOQ Protocol, 02-0047-IOP-1.0. Keywords: fda, gmp, gcp, gxp,...
$100.00
Virus Removal Capabilities of 12.8 Ab with the Fast Flow Quaternary Amine (FF Q) Chromatography Purification Process Edition: 1 Doxpub, Inc. / 01-Nov-2004 / 10 pages This document describes a process validation protocol for establishing the amount of removal/inactivation of various viruses in ABx purified 12.8 when passed over a Flast Flow Q (FF Q) column as described in Master Batch Records. Experiments using a scaled-down column diameter keeping equivalent column heights, linear flow...
$50.00
IOQ of PDI 420oe Imaging Densitometer, Report Edition: 1 Doxpub, Inc. / 01-Oct-2004 / 5 pages An IOQ report that describes the Conclusions and Recommendations of a successfully completed protocol for qualifying the PDI 420oe densitometer, controlled by Quantity One software, to test final products for release and stability. Includes Results & Analysis sections for each data collection form identified in the IOQ Protocol, 09-0061-IOR-1.0. Keywords: fda, gmp, gcp, glp, gxp, IOR, report,...
$110.00
Vial and Receiving Vessel Depyrogenation Process Validation, Report Edition: 1 Doxpub, Inc. / 01-Oct-2004 / 11 pages A process validation report that describes the Conclusions and Recommendations of a successfully completed PV Protocol for depyrogenating vials and receiving vessels used in the aspetic filling of Biotin. Includes Results & Analysis sections for each data collection form identified in the PV Protocol, 02-0042-PVP-1.0. Adheres to PDA Technical Report No. 7,...
$70.00
Stopper Cleaning Process Validation, Report Edition: 1 Doxpub, Inc. / 01-Oct-2004 / 7 pages A process validation report that describes the Conclusions and Recommendations of a successfully completed PV Protocol for the cleaning process of stoppers used as primary product closures. Includes Results & Analysis sections for each data collection form identified in the PV Protocol, 02-0040-PVP-1.0. Adheres to USP XXII, <788> Particulate Matter in Injections, Small Volume Injections....
$14.50
General Calibration Protocol Edition: 1.0 Doxpub, Inc. / 01-Aug-2007 / 3 pages Summary: Provide a general procedure for the calibration of instruments not covered by a specific calibration SOP. Applicable to the calibration of automatic, mechanical and electronic equipment not covered by a specific calibration SOP used in development, production, environmental control, and testing for products. Suitable for Manufacturing, Facilities, Product Engineering, and QA/QC. Included Sections:...
$90.00
Stopper and Aseptic Filling Component Sterilization Process Validation, Protocol Edition: 1 Doxpub, Inc. / 01-Oct-2004 / 9 pages A process validation protocol for demonstrating the effectiveness and reproducibility of sterilizing vial stoppers and aseptic filling components used in the aspetic filling of Biotin. Sterilization process incorporates Mueller autoclave, model SS-244 . Acceptance criteria includes Thermocouple values, 12-log reduction of bioburden values, non-growth of biological...
$140.00
Antibody Receiving Vessel Cleaning Process Validation, Protocol Edition: 1 Doxpub, Inc. / 01-Oct-2004 / 14 pages A process validation protocol for verifying the effectiveness and reproducitibility of a cleaning process for 5- & 10-Liter glass vessels used in bulk antibody receiving. Cleaning process incorporates Damas-AquaSan Washer, Model MK-4. Acceptance criteria includes bioburden, residual detergent, residual protein, and review of all procedures pertaining to the monitoring,...
$110.00
Vial Cleaning Process Validation, Protocol Edition: 1 Doxpub, Inc. / 01-Oct-2004 / 11 pages A process validation protocol for verifying the effectiveness and reproducitibility of a cleaning process for 5mL vials used as primary product containers. Cleaning process incorporates Cozzoli Rotary Vial Washer. Acceptance criteria includes endotoxin, bioburden, particulates, and review of all procedures pertaining to the monitoring, maintenance and operation of the system. Attached forms include a...
$84.00
Chemical Hygiene Plan Edition: 1.0 Doxpub, Inc. / 01-Aug-2007 / 57 pages Summary: Describes the procedures, equipment, personal protective equipment and work practices necessary to protect employees from the potential health hazards presented by hazardous chemicals in laboratories. Applies to personnel engaged in the use of chemicals. Includes provisions for personal protective equipment (PPE), safety glass and goggles, emergency equipment, purchasing, labeling, NFPA Hazard Warning Labels,...
$19.50
Operation and Maintenance of the Cleansphere CA100 Edition: 1.0 Doxpub, Inc. / 01-Aug-2007 / 4 pages Summary: Describes procedures for operating and maintaining the Safetech Cleansphere CA100 bench top portable mini-cleanroom. Applicable to Safetech Cleansphere CA100 devices used to simulate cleanroom conditions while performing aseptic procedures such as pouring supernatant, changing bottles and filters, and changing media bags. Included Sections: Purpose, Scope, Responsibility, References...
$9.50
SMEJA Stopper Washer Preventive Maintenance Edition: 1.0 Doxpub, Inc. / 01-Aug-2007 / 2 pages Summary: Describes the preventive maintenance procedures for the SMEJA Stopper Washer used in GMP production facilities. Includes provisions for system inspections, operational testing, and service reporting. Included Sections: Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures...
$29.50
Operation and Maintenance of The Lytzen Class 100 Dry Heat Sterilizer Edition: 1.0 Doxpub, Inc. / 01-Aug-2007 / 6 pages Summary: Provides procedures for dry-heat depyrogenation of glassware and metallic equipment using the Lytzen Dry Heat Sterilizer. Applicable to heat-resistant equipment and components, where depyrogenation by dry heat is required. Covers preparation, operation and preventive maintenance. Included Sections: Purpose, Scope, Responsibility, References and Applicable...
$49.50
Operation and Maintenance of the Clean Steam System Edition: 1.0 Doxpub, Inc. / 01-Aug-2007 / 10 pages Summary: Describes procedures for a Manufacturing and Development facility clean steam system. Includes provisions for operation, maintenance, monitoring, service contracts, calibration, sampling and testing, and documenting activities. Included Sections: Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations,...
$14.50
Audits of Clinical Research Edition: 1.0 Doxpub, Inc. / 01-Aug-2007 / 3 pages Summary: Describes a procedure for verifying that the documents and records for a given clinical study conform with clinical guidelines and FDA requirements. Intended for trials conducted in the US only. Covers criteria for performing selective audits, as well as internal and external audits requirements. Included Sections: Purpose, Scope, Responsibility, References and Applicable Documents, Materials and...
$4.50
Operation and Maintenance of the Clean Compressed Air System Edition: 1.0 Doxpub, Inc. / 01-Aug-2007 / 1 pages Summary: Describes the standard operating and maintenance procedures for a Compressed Air System in a manufacturing and development facility. Covers operation, maintenance, alarm handling, startup, shudown, backup with clean nitrogen system, and air quality testing. Included Sections: Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment,...