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Item No. | Item Name/Description | Price Each | Qty | ||
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10.000 | Standard Operating Procedures Please note that each SOP is delivered as a Microsoft Word 97-2003 Document to the email address you provide at checkout. | $0.00 | |||
10.001 | SOP - OOS Investigations SOP on how to conduct an OOS investigation. A must for every firm. | $40.00 | |||
10.002 | SOP - Cleaning Validation Requirements SOP on the requirements for a successful cleaning validation. | $50.00 | |||
10.008 | SOP - HEPA Filter Certification HEPA filter SOP - electronically available for your customization. | $75.00 | |||
10.010 | SOP - Inspection of Packaging Materials SOP on inspection of packaging materials - electronically available for your customization. | $20.00 | |||
10.011 | SOP - GMP Documentation Storage SOP on how to store documentation related to GMP operations - an electronic version is shipped ready for your personilization. | $20.00 | |||
10.012 | SOP - Customer Complaints SOP on handling customer complaints - an electronic version is shipped ready for your personilization. | $20.00 | |||
10.013 | SOP - General SOP Requirements An SOP on SOPs - an electronic version is shipped ready for your personilization. | $20.00 | |||
10.015 | SOPs - Drug Recalls An SOP on dealing with drug recalls - an electronic version is shipped ready for your personilization. | $25.00 | |||
10.016 | SOP - Signature Card System Tracking and documenting signatures for GMP requirements - an electronic version is shipped ready for your personilization. | $25.00 | |||
10.017 | SOP - Deviation Investigation Reports Dealing with deviations and investigation reports - an electronic version is shipped ready for your personilization. | $20.00 | |||
10.018 | SOP - Change Control Handling change controls SOPs - an electronic version is shipped ready for your personilization. | $40.00 | |||
10.019 | SOP - 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. | $20.00 | |||
10.020 | SOP - Laboratory Controls for GMP Testing SOP on laboratory controls for GMP testing - an electronic version is shipped ready for your personilization. | $20.00 | |||
10.021 | SOP - Quality Agreements and Third Party Manufacturers Detailed SOP on dealing with third party manufacturers - an electronic version is shipped ready for your personilization. | $60.00 | |||
10.022 | SOP - API Cleaning Validation Requirements Detailed SOP on cleaning validation requirements for Active Pharmaceutical Ingredients (APIs) - an electronic version is shipped ready for your personilization. | $50.00 | |||
10.023 | SOP - Quality Agreements for Clinical Supply Manufacturers Detailed quality agreement standards for clinical manufacturers - an electronic version is shipped ready for your personilization. | $50.00 | |||
10.024 | SOP - 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. | $20.00 | |||
10.025 | SOP - Blind Study Packaging Material SOP on packaging material requirements for blind studies - an electronic version is shipped ready for your personilization. | $20.00 | |||
10.026 | SOP - 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. | $70.00 | |||
10.027 | SOP - 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. | $30.00 | |||
10.028 | SOP - 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. | $20.00 | |||
10.029 | SOP - 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. | $25.00 | |||
10.030 | SOP - SOP Numbering System SOP on how to identify and number your SOPs - an electronic copy is sent to you for your ease in personalizing. | $20.00 | |||
10.031 | SOP - 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. | $65.00 |
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