|
Document Number |
Document Title |
|
Withheld |
Quality System Policy Manual |
|
Withheld |
Management Review |
|
Withheld |
Organization Chart Control |
|
Withheld |
Quality Plan |
|
Withheld |
Facility Inspection Procedure |
|
Withheld |
Contract Order Review Procedure |
|
Withheld |
Product Development Protocol |
|
Withheld |
How to Perform Failure Mode, Effect and
Criticality Analysis and Fault Tree Analysis |
|
Withheld |
Product Development Protocol for Pharmacy
Compounded Product |
|
Withheld |
Product Commercial Release Authorization Form |
|
Withheld |
Design Phase Review Checklist |
|
Withheld |
Design Phase Review and Product Development
Approval Form |
|
Withheld |
Design Input Evaluation Checklist |
|
Withheld |
Formulation and Compounding History Record
Checklist, Pharmacy Compounded Products |
|
Withheld |
Document Control |
|
Withheld |
Computerized Quality Record Documentation Control |
|
Withheld |
Document Change Notice Form |
|
Withheld |
Deviation to Established Compounding History
Record |
|
Withheld |
Supplier Selection and Evaluation Procedure |
|
Withheld |
Purchasing Procedure |
|
Withheld |
Supplier Qualification Plan |
|
Withheld |
Supplier Quality Systems Survey |
|
Withheld |
Label Control (DCN Controlled product) |
|
Withheld |
Batch and Lot Number Assignment Method |
|
Withheld |
Label Control (Non-DCN Controlled Product) |
|
Withheld |
Label Creation and File Control (All Product
Labels) |
|
Withheld |
Label Control Form |
|
Withheld |
Pharmacy Services Label Control Form |
|
Withheld |
Work Instructions and Production History Record
Requirements |
|
Withheld |
Standard Operating Procedure Requirements |
|
Withheld |
DCN Controlled Raw Materials Specification
Requirements |
|
Withheld |
Product Labels and Inserts Specifications
Requirements |
|
Withheld |
Equipment Preventive Maintenance System |
|
Withheld |
Component Analysis and Special process
Determination Procedure |
|
Withheld |
DCN Controlled Product Specification Requirements |
|
Withheld |
Facilities, Equipment and Tooling Document
Requirements |
|
Withheld |
Compounding History Record Requirements |
|
Withheld |
In-house test method procedure Requirements |
|
Withheld |
First Article procedure |
|
Withheld |
Incoming Materials Control |
|
Withheld |
Component History Form |
|
Withheld |
Quality Assurance First Article Inspection Record |
|
Withheld |
Raw Material Log Form |
|
Withheld |
Control and Calibration System For Inspection,
Measurements and test Equipment |
|
Withheld |
Calibration Record Form |
|
Withheld |
Calibration Control Number Assignment Form |
|
Withheld |
Calibration/Maintenance Corrective Action
Notification Form |
|
Withheld |
Inspection and Test Status |
|
Withheld |
Scrap Disposition Procedure |
|
Withheld |
Control of Non-Conforming Product |
|
Withheld |
Corrective and Preventive Action |
|
Withheld |
Product Notification and Recall |
|
Withheld |
Return Goods and Complaint Handling Procedure |
|
Withheld |
Product Misuse, Diversion or Other Anomaly
Investigation Procedure |
|
Withheld |
Medication Error Procedure |
|
Withheld |
Service Complaint Form |
|
Withheld |
Return Goods Authorization Form |
|
Withheld |
Corrective and Preventive Action Request Form |
|
Withheld |
Product Misuse, Diversion and Other Anomaly
Investigation Form |
|
Withheld |
Medication Error Form |
|
Withheld |
Product Complaint Form |
|
Withheld |
Inventory Control of Finished Goods |
|
Withheld |
Release and Distribution From Finished Goods |
|
Withheld |
Storage of Final Compounded Parenteral Products |
|
Withheld |
Production And Compounding History Record Control
System |
|
Withheld |
Master Formulation and Control File Procedure |
|
Withheld |
Quality Records Maintenance Procedure |
|
Withheld |
Master Formulation File Approval Sheet and
Revision History |
|
Withheld |
Quality Audits |
|
Withheld |
Training |
|
Withheld |
Statistical Methods |
|
Withheld |
Sampling Plans |
|
Withheld |
Order Processing Procedure |
|
Withheld |
Order Processing Procedure for Manufactured Goods |
|
Withheld |
"Pharmacy Prescription" Form (non-DCN Controlled
Product) |
|
Withheld |
"Request for Compounded Medications" (Completed by
physician) |
|
Withheld |
"Request for Compounded Medications" (Completed by
McGuff CPS employee) |
|
Withheld |
Lot Number Assignment Form |
|
Withheld |
Batch Number Assignment Form |
|
Withheld |
Requirements for Test, Qualification and
Validation Protocols and Reports |
|
Withheld |
Equipment Preventive Maintenance |
|
Withheld |
Protocol and Report Approval Sheet |
|
Withheld |
Withheld, USP |
|
Withheld |
Vial 20 mL, Serum, Glass, Clear |
|
Withheld |
Aluminum Flip-Top Regular Seals, 20mm |
|
Withheld |
Withheld, 10% (w/v), NF |
|
Withheld |
Sodium Hydroxide, 10% (w/v) |
|
Withheld |
Nitrogen, NF |
|
Withheld |
Vial 100 mL, Serum, Glass, Clear |
|
Withheld |
Sodium Hydroxide, Pellets, NF |
|
Withheld |
Withheld, 37% (w/w), NF |
|
Withheld |
Sodium Acetate, Anhydrous USP |
|
Withheld |
Sodium Chloride Powder, USP |
|
Withheld |
Acetic Acid, Glacial, USP |
|
Withheld |
Methyl Paraben, USP/NF |
|
Withheld |
Propyl Paraben, NF |
|
Withheld |
Withheld, USP |
|
Withheld |
Pantothenyl-L Alcohol FCC/USP |
|
Withheld |
Benzyl Alcohol, NF |
|
Withheld |
Vial 2 mL, Serum, Glass, Clear |
|
Withheld |
Vial 10 mL, Serum, Glass, Clear |
|
Withheld |
Vial 50 mL, Serum, Glass, Clear |
|
Withheld |
Vial 2 mL, Serum, Glass, Amber |
|
Withheld |
Vial 5 mL, Serum, Glass, Amber |
|
Withheld |
Vial 10 mL, Serum, Glass, Amber |
|
Withheld |
Withheld, Powder, USP |
|
Withheld |
Sterile Water For Injection (SWFI), USP |
|
Withheld |
Vial 30 mL, Serum, Glass, Clear |
|
Withheld |
Vial 30 mL, Serum, Glass, Amber |
|
Withheld |
Vial 50 mL, Serum, Glass, Amber |
|
Withheld |
Vial 100 mL, Serum, Glass, Amber |
|
Withheld |
Vial 5 mL, Serum, Glass, Clear |
|
Withheld |
Printer Ribbon, Resin 1.57 Inch Width |
|
Withheld |
Withheld, USP |
|
Withheld |
Vial, 20 mL, Serum, Glass, Amber |
|
Withheld |