SERVICES SPS CAN PROVIDE

General Areas of Focus
General Capabilities

Specific Services:

Water Systems
Contamination Control
Sterilization and Aseptic Processes
Operational and Regulatory Support
On Site Training
General Troubleshooting Approach

General areas of focus:     back to top

• Water Systems
• Sterilization and Aseptic processes
• Contamination control processes
• Laboratories (Chemistry and Microbiology / Development and QC)
• Validation of the above
• Regulatory and cGMP support for the above

General capabilities:     back to top

• Assess existing facilities, processes, and laboratories
• Assist client in establishing meaningful alert/action levels
• Troubleshoot root causes and assess impact of excursions and failures
• Determine regulatory liability
• Formulate responses to regulatory observations and actions
• Prepare Validation Protocols
• Prepare Remediation Project Plans
• Oversee Remediation Projects
• Provide personnel training programs

Specific Services:

• Water Systems     back to top
  • General water system assessment
  • Sampling plan and test procedure evaluation
  • Micro, TOC and Conductivity test method evaluations
  • Micro/Chem Alert & Action level and Limit establishment/evaluation
  • Design evaluation
  • Operation and maintenance procedure evaluation
  • Chemical, Microbial and Endotoxin Monitoring Data evaluations
  • Troubleshooting operational problems and excursion root cause analysis
  • Excursion impact analysis
  • Water system validation package analysis
  • Water system validation protocol analysis/preparation
  • Water system remediation plan preparation
• Contamination Control     back to top
  • Microbial control process assessment
  • Contamination troubleshooting and excursion root cause analysis
  • Excursion impact analysis
  • Sanitizer/Sanitization procedure analysis
• Sterilization and Aseptic Processes     back to top
  • Validation package assessment
  • Failure troubleshooting/root cause analysis
  • Environmental monitoring program analysis
  • Environmental data analysis
  • Alert/action level excursion investigation
  • Troubleshooting operational problems and excursion root cause analysis
  • Excursion impact analysis
  • Room classification, Air flow and DP analysis
  • Sanitizer/Sanitization procedure analysis
  • Sterility failure analysis
• Operational and Regulatory Support     back to top
  • Develop remediation plans for above needs
  • Oversee/direct remediation efforts using client resources
  • Recommend and coordinate 3rd party testing if needed
  • Regulatory and Quality System Auditing
  • Regulatory liability judgment
  • 483 response preparation/assistance
  • Warning Letter response preparation/assistance
  • Regulatory Commitment follow-through program management
• On Site Training (Click here for abstracts)     back to top
  • Understanding Biofilm in High Purity Water Systems
  • Practical Water System Design and Operation Issues Impacting Microbial Control
  • Validation of Microbial Enumeration Methods for Water
  • Optimizing Microbial Monitoring of Water Systems
  • The Logic of Water System Validation
  • Pharmaceutical Water System Excursions: Types, Impact and Response
  • Update on Latest USP Pharmaceutical Water Developments
  • USP-ology: Understanding the “Big Red Book”
  • Author’s Perspective on What USP’s Chapter <1231> Really Says About Water (& Why)
  • Water System Microbiology 101: The comprehensive course for everyone who tests & maintains water systems
  • Customized Training Programs – TBD by client needs

General Troubleshooting Approach     back to top

Step 1. On-site evaluation of problem or issue

Step 2. On-site troubleshooting using client resources if possible

Step 3. Devise workable remediation plan

Step 4. Oversee/coordinate remediation efforts using, as needed/available, Internal (Client) Resources, Contract Labs, Other Contract Companies