|
|
t | ||||
| HOME | ABOUT | SERVICES | NON-CLINICAL AND BIOANALYTICAL 483'S | PUBLICATIONS | CONTACT |
| Standard Operating Procedures | |||||
|
|
|||||
|
|
|||||
Standard Operating Procedures
Pharmaceutical Outsource Solutions, Inc. is proud to provide prepared Standard Operating Procedures (SOP's) that can be purchased and used either as single, stand-alone procedures or as an entire set that can be used as the basis for establishing all of the written procedures for an organization. SOP's will be licensed to the client and provided in a common word processing format. Contact us for specific SOP availability and pricing.
Who can benefit from prepared Standard Operating Procedures:
An organization that is performing bioanalytical testing internally to support research activities that wishes to transition to supporting GLP-compliant nonclinical and clinical studies and needs to implement a large number of Standard Operating Procedures quickly.
An organization that is performing bioanalytical testing but needs to augment or update its existing Standard Operating Procedures.
An organization that outsources bioanalytical testing but wishes to educate itself on industry standards for these activities.
An organization that outsources bioanalytical testing and is not satisfied with the procedures being used by the contract facility and wishes to provide alternative procedures for its samples.
Document Control (001.XXX)
Format and Use of SOP’s
Management of Controlled Documents
Training (002.XXX)
Employee Training
Administration (003.XXX)
Responsibilities of Management
Responsibilities of Study Director and Principle Investigator
Initiation of GLP Activities
GLP Protocols and Amendments
Client Complaints
Study Folder
Housekeeping, Safety and Waste Disposal (004.XXX)
General Housekeeping
General Procedure for Cleaning Laboratory Glassware
Pest Management
Safety
Equipment (005.XXX)
Test Methods and Sample Analysis (006.XXX)
Validation of Chromatographic Bioanalytical Methods
Validation of ELISA Bioanalytical Methods
Format and Use of Test Methods
Control and Distribution of Test Methods
Sample Analysis
Sample Reanalysis and Reporting
Incurred Sample Duplicate Reanalysis
Data Handling and Review (007.XXX)
Recording Raw Data in Laboratory Notebooks
Electronic Raw Data
Rounding of Numerical Data and Significant Figures
Data Review
Report Preparation and Format (008.XXX)
Method Validation Report
Study Sample Report
GLP Compliance Statements (QA)
Reagents and Solutions (009.XXX)
Receipt and Storage of Reference Standards and Reagents
Preparation of Standards and Reagents
Labeling of Reagents and Solutions
Water Monitoring and Analysis
Test, Control, and Reference Articles (010.XXX)
Test, Control Material
Reference and Internal Standards
Archiving (011.XXX)
Data and Report Archiving Procedure
Archives
Quality Assurance (012.XXX)
Role and Responsibilities of QA
Agency or Sponsor Audit
QA Inspection and Audit Procedures
Master Schedule
QA Recording and Reporting of Deviations and Nonconformance
Specimen Handling (013.XXX)
Procedure for Receipt, Transfer, and Storage of Samples
Procedure for Archiving Samples
Procedure for Disposing of Samples
Deviations (014.XXX)
Documentation and Corrective Action for Deviations
|
|
Service areas
Standard Operating Procedures
Compliance
and Techical Auditing
Training
and System implementation
Trouble
Shooting and Data Validation
Why use Pharmaceutical Outsource Solutions?