COMMISSIONING & QUALIFICATION
Our PharmEng professionals have extensive experience in the development, implementation and execution of:
- Enhanced Detail Design Reviews - Design Qualification (DQ)
- Risk Management Tools
- Commissioning / Qualification / Validation Master Plans
- Project Management Tools (Budgeting, Scheduling, Tracking, Resource Planning)
- Facility / Utility System Commissioning Test Procedures
- Critical Utility System Qualification (IQ/OQ/PQ) Protocols
- Process Equipment and Process System Qualification (IQ/OQ/PQ) Protocols
- Controlled Temperature Units(IQ/OQ/PQ) Protocols
- Process Control Systems(IQ/OQ/PQ) Protocols
- Packaging Lines(IQ/OQ/PQ) Protocols
- Laboratory Instrumentation (IQ/OQ/PQ) Protocols
PharmEng has an extensive background in completing Validation Projects; these include cleaning, facility and utility, equipment, process, and computer validations.
With years of experience serving renowned clients in biotechnology, pharmaceuticals, medical devices, and nutraceuticals industries, our specialists follow a systematic approach to identify, assess, and successfully resolve a wide range of quality system issues that can be seriously damaging to our clients’ business. We are proud to offer you our world-class quality system services in the following:
- Quality management consultation and training
- ISO and cGMP implementation
- Gap and quality performance analysis
- Quality system documentation
- Audit and inspection management
- Risk and crisis management
- Comprehensive validation services
PharmEng supports Pharmaceuticals, Biologics, Over-The-Counter (OTC), Animal Health, Radiopharmaceuticals, Clinical Trial Products, Medical Devices, Combination Products, Natural Health Products, Personal Care, Disinfectants, and Active Pharmaceutical Ingredients (API) to achieve the most cost-effective way to undertake their regulatory activities worldwide. This includes regulatory intelligence and strategy, worldwide product registration, preparation of regulatory documents, in country representation, establishment registration, and post-approval submissions.
Our experts have successfully completed facility and process engineering projects including; vaccine manufacturing, sterile manufacturing, oral solid and liquid dosage manufacturing, API manufacturing, medical device manufacturing, and more.
We offer a full range of services including:
- Facility and process planning and design
- Automation and process controls
- Pharmaceutical process engineering
- Facility and process validation
- Occupational health and safety management
- Environmental impact management
Our experience has allowed us to develop the following tools for tracking all types of Data Integrity issues:
- Draft protocols and reports
- Prerequisite checklists
- Outlines for testing procedures
- Distinct and detailed frameworks
- Remediation plans
PharmEng has been providing training programs to regulated industries for more than a decade. We customize our programs to fit client needs. Our course offerings include: cGMPs/ GLPs, Validation, Engineering, Regulatory Affiars, Quality Assurance, Manufacturing Processes, and more.
Our instructors are experienced professionals with diverse backgrounds from industry, government and academia. Course materials are developed in-house and are constantly updated to keep current with industry practices and changing regulatory environments.
The courses we provide include real-life examples from industry, with case studies and hands-on exercises to illustrate concepts.