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Item No.   Item Name/DescriptionPrice EachQty 
10.000Standard Operating Procedures
Please note that each SOP is delivered as a Microsoft Word 97-2003 Document to the email address you provide at checkout.
10.001SOP - OOS Investigations
SOP on how to conduct an OOS investigation. A must for every firm.
10.002SOP - Cleaning Validation Requirements
SOP on the requirements for a successful cleaning validation.
10.008SOP - HEPA Filter Certification
HEPA filter SOP - electronically available for your customization.
10.010SOP - Inspection of Packaging Materials
SOP on inspection of packaging materials - electronically available for your customization.
10.011SOP - GMP Documentation Storage
SOP on how to store documentation related to GMP operations - an electronic version is shipped ready for your personilization.
10.012SOP - Customer Complaints
SOP on handling customer complaints - an electronic version is shipped ready for your personilization.
10.013SOP - General SOP Requirements
An SOP on SOPs - an electronic version is shipped ready for your personilization.
10.015SOPs - Drug Recalls
An SOP on dealing with drug recalls - an electronic version is shipped ready for your personilization.
10.016SOP - Signature Card System
Tracking and documenting signatures for GMP requirements - an electronic version is shipped ready for your personilization.
10.017SOP - Deviation Investigation Reports
Dealing with deviations and investigation reports - an electronic version is shipped ready for your personilization.
10.018SOP - Change Control
Handling change controls SOPs - an electronic version is shipped ready for your personilization.
10.019SOP - Guidelines on the Validation of Assay Methods
SOP detailing at legth the requirements for assay validation - an electronic version is shipped ready for your personilization.
10.020SOP - Laboratory Controls for GMP Testing
SOP on laboratory controls for GMP testing - an electronic version is shipped ready for your personilization.
10.021SOP - Quality Agreements and Third Party Manufacturers
Detailed SOP on dealing with third party manufacturers - an electronic version is shipped ready for your personilization.
10.022SOP - API Cleaning Validation Requirements
Detailed SOP on cleaning validation requirements for Active Pharmaceutical Ingredients (APIs) - an electronic version is shipped ready for your personilization.
10.023SOP - Quality Agreements for Clinical Supply Manufacturers
Detailed quality agreement standards for clinical manufacturers - an electronic version is shipped ready for your personilization.
10.024SOP - Cleaning, Verif. & Valid. of Investigational Drugs
An SOP listing requirements for cleaning, verification and validation of investigational drugs - an electronic version is shipped ready for your personilization.
10.025SOP - Blind Study Packaging Material
SOP on packaging material requirements for blind studies - an electronic version is shipped ready for your personilization.
10.026SOP - Testing, Adjusting and Balancing HVAC Systems
A detailed SOP covering the testing, adjustment and balancing requirements for your HVAC system - an electronic copy is sent to you for your ease in personalizing.
10.027SOP - Systems Numbering
This SOP provides detailed guidance on establishing a numbering system for your various systems - an electronic copy is sent to you for your ease in personalizing.
10.028SOP - Statistical Inspection of Finished and Packaged Product
An SOP detailing the statisical requirements for examining finished and packaged product - an electronic copy is sent to you for your ease in personalizing.
10.029SOP - Stability Program Guidelines
Can be used as an SOP or a policy regarding stability - an electronic copy is sent to you for your ease in personalizing.
10.030SOP - SOP Numbering System
SOP on how to identify and number your SOPs - an electronic copy is sent to you for your ease in personalizing.
10.031SOP - Sampling Guidelines-Non-Sterile Products
A detailed SOP or policy regarding sampling programs for non sterile products - an electronic copy is sent to you for your ease in personalizing.


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