Syntiro consultants are always Senior persons with a proven track record in the Pharmaceutical industry.
Syntiro can provide resources under a Statement of Work (SOW). Syntiro remains responsible for management of the employees and for the output in terms of quality of work delivered and timelines.
Syntiro can also provide free-lance workers on a temporary assignment under your management and responsibility.
design and set-up quality system
Syntiro consultant can be part of your team or can take this on as a project.
Design of Quality System
Syntiro will analyze your company and determine the best processes for quality management, document control, qualification and validation, production documentation, quality control, archiving and logistics. A proposal will be made for software to support these processes. Always keeping resources and budget in mind.
A Quality System for a pharmaceutical company must be at least compliant with ICH guidelines.
Set-up of Quality System
Syntiro will determine the required documents together with you. Syntiro consultant writes required documents such as SOP, Forms, Test Procedures, Validation (Master) Plans, Reports. When internal resources are writing documentation, Syntiro consultant can review and advise.
The Quality System should be tuned to the operational activities in order to make it effective!
A Syntiro consultant can be hired as a Project Manager. Applicable to small and medium sized projects. The Project Manager can work with both internal or external resources. Responsibilities: team leader, planning, external resources and services, budget, timelines, scope and quality.
When assignments are taken on as project, Syntiro will always deliver project management.
- Set-up or improve Quality System
- Set-up or improve Documentation System
- Procurement, installation and qualification of equipment or utility installations
- Design and execution of qualification studies, including documentation
- Qualification of plant automation systems
- Shipping qualification/validation
- Cleanroom construction, commissioning and qualification
design and execution of qualification and validation studies
Syntiro can take on assignments covering your qualification/validation needs: study design, document writing, execution and reporting. As part of your team, a Syntiro consultant can also take on partial assignments such as document writing, study execution and reporting or a Quality Assurance role (review, advise and approval).
Syntiro can take on small or medium sized assignments: single equipment up to medium size plant automation systems.
Syntiro can include external resources and services as required by the qualification or validation protocol such as measurement of physical cleanroom parameters (e.g. T, P, rH) or microbiological testing (e.g. TMC for air and surface).
- Production equipment
- Laboratory equipment
- Cleanroom production areas
- Storage areas
- Utility systems (Water, air, gases)
- Automation systems
- Packaging lines
- Shipment containers
- Process validation
- Cleaning validation
- Shipping validation
- Computerized systems validation (CSV)
- Assay validation
Qualification studies will be designed according to the V-model.
Validation studies will be designed according to the applicable regulatory requirements.
document writing for quality system or regulatory requirements
Syntiro can deliver all kind of documents required for your GMP environment. Assignments can be given for single documents up to projects for complete documentation packages comprising at least but not limited to Quality System SOPs, Site Master File, Validation Master Plan, Production Batch Records and operational SOPs.
Documents will always be written according to templates currently used in your organization. If templates are not available, Syntiro can provide them for all kinds of documents including but not limited to SOPs, Batch Records, Forms (paper based or PDF based) and Qualification/Validation study protocols.
If required Syntiro will adapt to and use your electronic document control system for document generation, review and approval
Syntiro can also write Evaluation/Expert Reports, Position Paper or White Papers on certain issues requiring more explanation and/or clarification towards regulatory inspections.
Documents will be written according to (local) regulatory requirements and guidelines.
perform or prepare for audits
Syntiro can do audits for you such as self-inspections, vendor audits and inspection of outsourced activities (CMO, contract lab, packaging, logistics & warehousing, archiving).
Syntiro can help you prepare for regulatory or client audits. A Syntiro consultant can perform a pre-inspection audit and find out your weak points and help you how to improve.
And audit preparation program could look like this:
- Introduction to your organization and key staff
- Perform pre-inspection audit
- Define improvement plan
- Assist in execution of improvement plan
- Training of employees
- Rehearsal of communication with an inspector
- Check inspection readiness
Important to successful inspections: Be prepared and know how to defend your weak points.
training of staff
Training is one of the most important activities in quality management. It is a regulatory requirement that a company is able to demonstrate that each employee is trained in the tasks assigned to him/her. On the other hand, employees should only performed tasks they are trained for.
Syntiro can help you with setting-up a training program and documentation system. A training program requires role profiles and task definitions, including expected responsibilities and performance.
Syntiro can give general GMP training to your staff. These trainings include but are not limited to:
- General GMP training (the basics)
- Good Documentation Practice
- Good Distribution Practice (for employees in the logistics sector)
- How to behave in a cleanroom
Training given by Syntiro is always adapted to your internal procedures.