- - - Standard Operating Procedures - SOP/WI (F) (See Above) - More...*

  - - - Requesting, Writing and Challenging Procedures (F) - More...*

  - - - Risk Management (F) - More...*

  - - - Corrective and Preventative Actions (CAPA) (F) - More...*

  - - - Non-Conformance (F) - More...*

  - - - Change Control (F) - More...*

  - - - Deviations (F) - More...*

  - - - Complaints Management (F) - More...*

  - - - Recalls and Recall Challenge (F) - More...*

  - - - Quality Assurance Procedures (other) - More...*

  - - - Internal Audit (F) - More...*

  - - - External Audit (F) - More...*

  - - - Agency Audit - More...*

  - - - Customer Audit - More...*

  - - - Traceability (F) - More...*

  - - - Good Documentation Practice (GDocP) Standards - More...*

  - - - Document Management and Document Control (F) - More...*

  - - - Document Management Archive and Disposition (F) - More...*

  - - - Form Management (F) - More...*

  - - - Logbook Control and Quality Review - More...*

  - - - Out of Specification (OOS) (F) - More...*

  - - - Contractors - More...*

  - - - Regulatory Affairs - More...*

  - - - Product Safety - More...*

  - - - Reporting to Regulatory Agencies - More...*

  - - - Audit Reports - More...*

  - - - Annual Product Review - More...*

  - - - Annual and Preschedule Quality Meetings (Review) (F) - More...*

  - - - Out of Trending / Out of Tolerance (OOT) (F) - More...*

  - - - Rework and Reprocessing (F) - More...*

  - - - Managing Visitors (F) - More...*

  - - - Pharmacy Operations - More...*

  - - - Compounding - More...*

  - - - Disaster Recovery and Business Continuity (F) - More...*

  - - - Signature Logs - More...*

  - - - Review of Quality Documents (Batch/Assembly Records) - More...*

  - - - Review of Quality Critical Documents - More...*

  - - - Review of Contracts and Scope of Work Agreements - More...*

  - - - Vendor Qualifications (F) - More...*

  - - - HACCP Management - More...*

  - - - Research and Development - More...*

  - - - Pilot Plant Scalability - More...*

  - - - Process Improvement - More...*

 

- Human Resources * Requires Login

  - - - Training and Development - More...*

  - - - Hiring and Releasing - More...*

  - - - CV Management - More...*

  - - - Roles, Responsibilities and Job Descriptions - More...*

  - - - Employment - More...*

  - - - GMP Training Curriculum with Curriculum - More...*

  - - - GLP Training Curriculum with Curriculum - More...*

  - - - Employee Safety - More...*

  - - - Background Checks and Drug Testing - More...*

  - - - Regulation of Food, Drink and Smoking - More...*

  - - - New Employee Orientation - More...*

 

- Warehouse, Receiving and Shipping * Requires Login

  - - - Receiving - Materials - More...*

  - - - Quarantine - Incoming and Finished Products - More...*

  - - - Rejected Materials - More...*

  - - - Sampling - Area Management - More...*

  - - - Inventory Control - Cycle Counting and Reconciliation - More...*

  - - - Label Management and Label Control - More...*

  - - - Retains - Area and Inventory Management - More...*

  - - - Reserves - Area and Inventory Management - More...*

  - - - Experimental - Area and Inventory Management - More...*

  - - - Returns - Area and Inventory Management - More...*

  - - - FIFO - First In - First Out Management - More...*

  - - - Waste - Area and Inventory Management - More...*

  - - - Cleaning - Area - More...*

  - - - Shipping - Area Management - More...*

  - - - Controlled Environments and Area Management - More...*

 

- Facilities * Requires Login

  - - - Asset Management - More...*

  - - - Maintenance and Preventive Maintenance Management - More...*

  - - - Work Order Management - More...*

  - - - Pest Control - More...*

  - - - Metrology and Calibration Management - More...*

  - - - Engineering and Engineering Change Management - More...*

  - - - Drawings, Schematics and Flow Diagram Management - More...*

  - - - Contractors and Consultants - More...*

  - - - Environmental, Safety and Health - More...*

  - - - Temperature / Humidity Management - More...*

  - - - Building Monitoring/Management Systems - More...*

  - - - Filter Management - More...*

  - - - Balancing Load Management - More...*

  - - - Housekeeping and Janitorial - More...*

  - - - Plant/Facility Security Management - More...*

  - - - Control Substance Management - More...*

  - - - Emergency Safety Evaluation - More...*

  - - - Handling of Hazardous Materials - More...*

  - - - Handling of Flammable Materials - More...*

  - - - Drain Cleaning and Sanitization - More...*

  - - - Cleaning and Maintaining Air Handling Equipment and Ducting - More...*

  - - - Gowning and De-gowning Procedures - More...*

  - - - Use of Approved Cleaning Chemicals - More...*

  - - - Redundant Systems (Generators, Grids and UPS systems) - More...*

  - - - Compressed Air Systems (General Use and Process) - More...*

  - - - Compressed Gas Systems - More...*

  - - - Vacuum Systems - More...*

 

- Quality Control and Laboratories * Requires Login

  - - - Sampling Incoming and Finished Products and Materials Receipt - More...*

  - - - Sampling, Testing & Approval or Rejection of Components - More...*

  - - - Sampling, Testing & Approval or Rejection of Active and Inactive ingredients - More...*

  - - - In-Process Control Points - More...*

  - - - Batch or Assembly Record Review and Verification - More...*

  - - - Sample and Test Article Management - More...*

  - - - Balances and Scales - More...*

  - - - Laboratory Information Management System - More...*

  - - - Electronic Notebook System - More...*

  - - - Reagent Management - More...*

  - - - Column Management - More...*

  - - - Test Samples - More...*

  - - - Qualification and Validation - More...*

  - - - Contractors - More...*

  - - - Stabilities and Stability Management - More...*

  - - - Water Systems Testing, Potable, Purified and WFI Systems - More...*

  - - - Microbiology and Sterility Testing - More...*

  - - - Reporting and Record Management - More...*

  - - - Verification Process - More...*

  - - - Disposal of Process Waste and Effluent - More...*

  - - - Release of Finished Materials - More...*

  - - - Quality Agreements - More...*

 

- Validation/Qualification * Requires Login

  - - - Process Validation - More...*

  - - - Equipment Validation - More...*

  - - - Software and Computer Systems/Hardware Validation - More...*

  - - - Cleaning Validation - More...*

  - - - Facility Qualifications - More...*

  - - - Method and Analytical Process Validation - More...*

 

- IT and Electronic Systems * Requires Login

  - - - Backup and Recovery - More...*

  - - - Disaster Recovery and Business Continuity - More...*

  - - - Backup and Recovery Challenging Process - More...*

  - - - Upgrade and Downgrade - More...*

  - - - Change Control - More...*

  - - - Configuration Management - More...*

  - - - Software / Systems Development Life Cycle  - More...*

  - - - Development of Software/Systems User Requirements Specifications (URS) - More...*

  - - - Development of Software/Systems Functional Requirement Specifications (FRS) - More...*

  - - - Software Use Policies and Internet Usage - More...*

  - - - Software Risk Assessment - More...*

  - - - Hardware Risk Assessment - More...*

  - - - Network Access Policies - More...*

  - - - New Hardware Installation - More...*

  - - - New Software Installation - More...*

  - - - Hardware Maintenance - More...*

  - - - Software Maintenance - OEM and Internal - More...*

  - - - Computer Systems Hardware Testing and Validation - Writing IQ, OQ, PQ - More...*

  - - - Computer Systems Software Testing and Validation - Writing IQ, OQ, PQ - More...*

  - - - 21 CFR Part 11 Electronic Systems / EU Annex 11 Computer Systems - More...*

  - - - Virus Protection, Log reviews and Definitions updating processes - More...*

  - - - Firewall Protection, Log reviews and Definitions updating processes - More...*

  - - - UPS and Redundant Power Supply - More...*

  - - - Imaging of computer systems (Clients and Servers) - More...*

  - - - Data Base Administrator (DBA) Procedures - More...*

  - - - Ghosting and/or Mirroring Processes - More...*

  - - - Spreadsheet Qualification - More...*

  - - - Off Site Storage - More...*

  - - - Tape Management, Chain of Custody and Degaussing Procedure - More...*

  - - - Internal Systems Audit - More...*

  - - - Vendor Qualifications, Hardware, Software, Consultants and Contractors - More...*

  - - - Administrative Rights - More...*

  - - - Database Administrative Activities - More...*

  - - - Physical Security - More...*

  - - - Computer Room Management and Alarming Systems - More...*

  - - - Computer Room Environmental Systems and Alarming Systems - More...*

  - - - Help Desk Management - More...*

  - - - Drawing, Schematics, Flow Diagrams and other Quality Critical Documents - More...*

  - - - Good Programming Practices - More...*

  - - - Code Management - More...*

  - - - Test Platforms - More...*

  - - - Qualification and Validation - More...*

 

- Manufacturing and Processing * Requires Login

  - - - Batch Record Management (BRM) - More...*

  - - - Batch Master Records (BMR) - More...*

  - - - Dispensing of Materials - More...*

  - - - Cleaning of Equipment (Cleaning Qualification) - More...*

  - - - Use of Status Labels (Equipment and Areas) - More...*

  - - - Packaging Procedures - More...*

  - - - Line Clearance Procedures - More...*

  - - - Staging Procedures (Materials, Components and Labels) - More...*

  - - - Use of Approved Lubricants, Oils and Cleaning Agents - More...*

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