Integrated Commissioning & Qualification Corporation (ICQ) is a leading provider of commissioning, qualification and verification services to companies in the life sciences and pharmaceutical industries. We develop programs and procedures that promote, facilitate and ensure compliance with stringent regulatory standards and our clients’ own internal quality standards. During our history, teams of ICQ consultants have played a central role in the commissioning and qualification of multiple manufacturing plants in the New England area as well as North Carolina. ICQ consists of eighty plus employees all qualified in the different areas of the industry that we as a company specialize in.
We thrive on the long-term success of our clients. We at ICQ make every effort to establish strong continuing relationships. Our company strives to blend in at the client site and become an extension of each client company we work with. ICQ offers many services from the start-up and commissioning of new facilities, utilities, process equipment and processes to decommissioning or project planning. No matter which service you require we have an experienced professional to place into our client sites.
◊ Equipment/Facilities CQ &V ◊ Process Engineering ◊ Process Validation ◊ Manufacturing Operations ◊ Quality Systems and Remediation ◊ Consent Decree Remediation ◊ Construction and Program Management ◊ Project Planning and Scheduling ◊ Compliance Support ◊ Quality Control and Assurance ◊ Re-Qualification ◊ Decommissioning ◊ Commissioning Activities (IV, OV, IQ & OQ) ◊ Engineering Change Management ◊ Cycle Development (CIP & SIP) ◊ Engineering Test Plans ◊ Start-Up and Turn-Over ◊ Shake Down Activities ◊ Project Execution ◊ Cleaning Validation (CIP/COP) ◊ Sterilization Validation (SIP/SOP) ◊ Process Validation ◊ Mixing Validation ◊ Clean/Dirty Hold Validation ◊ Expiry Validation ◊ Cleaning Verification (CV) ◊ Validation Maintenance ◊ Assistance with Compliance Audits ◊ Development and Management of Compliance Action Plans ◊ Regulatory Readiness Inspections and Training ◊ Response to Regulatory Citations and Warning Letters ◊ Design of Quality Systems for New Facilities or New Process Lines ◊ Ongoing QA/QC Support ◊ Preparation of Regulatory Filing and Review Documents ◊ Implementation of Quality by Design (QbD), ICH-Q9, ICH-Q10, ASTM E2476, ASTM E2500 Principles and Approach ◊ Project Managers ◊ Project Leads ◊ C&Q Technical Leads ◊ C&Q Consultants ◊ C&Q Engineers ◊ C&Q Specialists ◊ Documentation Specialists ◊ Construction Managers
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