Facilities, Utilities, Support Systems
- Assessment of safety and environmental requirements
- Enhancement of quality engineering requirements, specifications, and drawings
- Development of standard operating procedures (SOPs) to address HVAC, water, sterilization and dust-control requirements
- Assessment and/or enhancement of facilities requirements against manufacturing, assembly, packaging/labeling and distribution operations
- Addressing the effective flow of materials, equipment and personnel
- Auditing or review during the construction and installation phases
- Identification of gaps in compliance related to facilities design/construction and implementation of corrective and preventive action plans
- Drafting, review and gap analysis of Site Master Files
Manufacturing Operations
- Addressing manufacturing processes and specifications for sterile & non-sterile formulations
- Development of standard operating procedures (SOPs) and specific written procedures for manufacturing operations
- Facilities and Equipment System
- Materials System
- Production System
- Packaging and Labeling System
- Laboratory System
- Support with Qualification and Validation activities (DQ, IQ, OQ and PQ)
- Facilities critical utilities and equipment
- Production, packaging and labeling processes
- Laboratory instruments
- Review of protocols and reports
- Implementation of production & laboratory controls
- New Product Introduction Systems
Quality & Compliance
- The setting up, upgrading, and assessment of GMP quality management systems
- Design of quality assurance systems to the specific needs of the organization
- Master Document Design
- Development, Implementation and/or optimization of Change Control systems
- Identification and implementation of process improvements
- Drafting and review of contractual agreements (technical, quality)
- Development and implementation of corrective and preventive action (CAPA) plans and programs
- Risk based reviews and assessments
- Pre-inspection readiness activities and follow-up
- Audits
- GMP for Active Pharmaceutical Ingredients (APIs) and finished products
- GCP (Good Clinical Practice)
- GLP (Good Laboratory Practice)
- Contract manufacturers
- Qualification of Vendors and Suppliers
- Training
- Customized training sessions to suit your organization’s needs
- From the basic principles to advanced levels of GMP
Scope: EMA, US FDA, ICH guidelines, regulations and standards
