Consulting Services to the Pharmaceutical Packaging Industry

//Consulting Services to the Pharmaceutical Packaging Industry
Consulting Services to the Pharmaceutical Packaging Industry2018-08-02T21:30:55+00:00
Focus Compliance & Validation Services provides engineering and consulting services to primary and contract pharmaceutical packaging companies. These services include the implementation of systems, procedures, and documentation to meet the FDA Quality System regulations affecting the packaging industry. Focus has extensive expertise in providing consulting services in the area of Quality System Regulation, Regulatory Compliance, Validation and Qualification Services, Computer Validation, and On-Site Training.

Validation and Qualification Services

  • Standard Operating Policy and Procedure Development/Implementation
  • Quality Assurance Planning
  • Validation Gap Assessments
  • Validation Master Planning
  • Process Validation
  • Equipment Validation
  • Cleaning Validation
  • Critical Facility and Utility Qualification/Validation (Water, Steam, Gases, Compressed air, Temperature, Humidity)
  • Protocol Development and Execution
  • Documentation Management (IQ, OQ, PQ, and Final Reports)
  • Internal Auditing Services
  • Nonconformance and Complaint Management
  • Corrective and Preventative Actions (CAPA) Program Development
  • Document and Engineering Change Control
  • Environmental Monitoring Planning and Execution (Particulate Matter Control Planning, Sampling and Analysis Plans, Analytical Data Review)
  • Corporate On-site Training
  • Computer and PLC System Validation

Standard Operating Policy and Procedure Development/Implementation

Focus capabilities include the development and implementation of standard operating procedures, packaging specifications, packaging protocols, equipment setup sheets, equipment challenges, and other procedures required for daily production.  During development of written procedures, Focus interacts with all stakeholders to ensure that written procedures adequately address both regulatory requirements and practical limitations or requirements of the affected equipment and systems.

Quality Assurance Planning

Focus capabilities include assisting senior management with setting quality objectives, defining the operational and/or quality system processes and the resources needed to fulfill the objectives, establishing performance indicators, and the communication and implementation of the establisehd objectives.

Validation Gap Assessments

Focus capabilities include performing Validation Gap Assessments used to identify deficiencies in the validation programs.

Validation Master Planning

Focus capabilities include development of Master Validation Plans (MVPs) for an entire facility or project specific MVPs.  To ensure proper development of MVPs, Focus works with both validation and quality team members to determine utilities, equipment, components, and/or systems that will require validation, evaluate risks associated with each component, determine when revalidation of components will be required, and develop a strategy to implement validation.

Process Validation

Focus capabilities include development of process validation protocols for various processes used for the packaging of pharmaceutical products including bottling, blister packing, labeling (including various types of coding), cartooning, kit packaging, etc.

Equipment Validation

Focus capabilities include development of equipment validation protocols for various types of equipment used for the packaging of pharmaceutical products including unscramblers, fillers, cappers, induction sealers, retourquers, labelers, topserters, sideserters, vision systems, blister forming and sealing machines, cartoners, neckbanders, bundling and shrink wrapping, etc.

Cleaning Validation

Focus capabilities include development of cleaning validation procedures and protocols for various types of parts and procedures including the creation of cleaning procedures and sampling methods, development of and execution of protocols, and determination of the analytical methods to be used and their respective detection limits.

Critical Facility and Utility Qualification/Validation (Water, Steam, Gases, Compressed air, Temperature, Humidity)

Focus capabilities include development of critical facility and utility validation protocols for various types of utilities and facility equipment including waters systems, air compressors, heating and cooling units, dehumidifiers, air purification systems, etc.

Protocol Development and Execution

Focus capabilities include development of packaging protocols, packaging specifications, rework protocols, and work instructions for clients and provides technical support as needed during the execution of the documents.

Documentation Management (IQ, OQ, PQ, and Final Reports)

Focus capabilities include development of validation documents including installation, operational, and performance qualifications engineering studies and line trials.  Focus also provides reviews of executed qualification documents and produces final reports including documentation and investigation of any nonconformance events noted during execution.

Internal Auditing Services

Focus capabilities include internal auditing services to clients including auditing of procedures, documentation, mock recalls, and records management.

Nonconformance and Complaint Management

Focus capabilities include assisting clients in the investigation, development of corrective action and the management and tracking of complaints and nonconformance events.

Corrective and Preventative Actions (CAPA) Program Development

Focus capabilities include development of CAPA programs.  To ensure that a complete and workable CAPA program is developed and implemented, Focus works with all stakeholders to identify existing and potential quality issues and determine the appropriate procedures to be developed to address the detection, resolution, and evaluation of effectiveness of quality issues.

Document and Engineering Change Control

Focus capabilities include the development of document and engineering change control procedures

Environmental Monitoring Planning and Execution (Particulate Matter Control Planning, Sampling and Analysis Plans, Analytical Data Review)

Focus capabilities include the development of environmental monitoring plans including the creation of monitoring procedures and sampling methods, development of and execution of protocols, and determination of the analytical methods to be used and their respective detection limits.

Corporate On-site Training

Focus capabilities include providing onsite training material and onsite training sessions for a variety of topics, including site specific SOPs, cGMP, environmental monitoring, etc.

Computer and PLC System Validation

Focus capabilities include assisting clients with risk analysis, validation planning, documentation preparation, and protocol execution required to efficiently and effectively qualify computer and PLC systems.