Consulting Services

GMP – Manufacturing

The goal of our services as GMP consultants is encourage both science and compliance.

  • Guidance and assistance in meeting the requirements of FDA’s Aseptic Processing Guidance.
  • Consulting on manufacture of non-sterile product dosage forms and API with particular emphasis on the requirements of the newly harmonized Microbial Limits Tests.
  • Consultation on modernizing, or on “greening” established API production processes.
  • Assistance in responding effectively to FDA observations and warning letters.
  • cGMP audits of facilities and associated control systems for both sterile and non-sterile finished dosage forms.
  • Project management services.
  • Process development for contamination control
  • Sterilization sciences
  • Process development for contamination control
  • Sterilization sciences

GMP – Laboratory

The Microbiology Laboratory is critical to the regulatory stability of your QC organization, and so your marketed product.

  • Design of microbial identification strategy to assist in investigations while maintaining operating expenses.
  • Review of documentation and assistance in compliance.
  • Management of change to establish and maintain a compliant laboratory culture.
  • Design and evaluation of a SOP system to support compliance and training.
  • Auditing of Pharmaceutical laboratories in preparation for regulatory inspections and also as an aid to benchmarking and training.
  • Laboratory investigation support, e.g., sterility test failure and media fill failure investigations, evaluation of aseptic processing procedures
  • Training on critical knowledge and skills brought to your site from recognized and experienced experts in the field. Courses can be developed to meet your needs, or can be chosen from a election of prepared units including:
  • Microbiology and the USP
  • Validation of microbiological methods
  • Microbiology validation – theory and practice
  • Auditing a Microbiology Lab (and preparing for the audit)
  • Techniques in effective laboratory organization, leadership and management
  • Project management services.

Lab Management

  • Design of the laboratory to assist in work flow and efficiency
  • Assistance in equipment acquisition, documentation and validation to maximize efficiency.
  • Training in all aspects of microbiology in the pharmaceutical, medical device and consumer products industries.
  • Optimization of laboratory operations and procedures.
  • Development of environmental control procedures
  • Quality engineering and quality management evaluation of your laboratory
  • Laboratory automation.
  • Project management services.

Contamination Control

  • Creation of Contamination Control Plan
  • Integration of Environmental Monitoring, incoming materials QC, in-process controls, cleaning & sanitization program and personnel monitoring
  • Investigation of finished product contamination issues
  • Facility Reviews

Project Management

  • Assistance in developing project strategy for process change, product development where circumstances require significant microbiological expertise
  • Assistance in technical documentation to support NDA/ANDA/CTD filing.
  • Skilled manager in all aspects of microbiological testing to meet product development or process change needs.
  • Assistance with regulatory submissions and interactions.
  • Assistance in development of metrics to reflect laboratory operations

Rapid Microbiological Methods and PAT

  • Application of Rapid Microbiological Methods to support manufacturing within the Process Analytical Technology Initiative.
  • Recommendation and validation of appropriate alternate microbiological technology to maximize efficiency.
  • Evaluation of your current manual growth-based systems with recommendations and implementation of a rapid system that suits your user requirements.
  • Comprehensive Installation Qualification, Operational Qualification, and Performance Qualification validation protocols and execution, as well as process development and validation study services for the new rapid technology.

Our principal, Scott Sutton, is dedicated to the concept of true science-based compliance.