Services
QUALIFICATION & VALIDATION
for GMP projects
Consulting SRLs frequently executes validation projects on a fixed price basis or can offers our experienced Validation Consultants Engineers at an hourly rate basis to work at your site.
- Equipment/Utility Qualification
- Process & Cleaning Validation
- Computer System Validation
- SAT/FAT
- Validation Master Plan
DAILY BUSINESS SUPPORT
for GMP projects
Our staff is on site 40 hours a week, integrated in your teams and completing the work according to your specific directions. This way you benefit from an efficient support in all your GMP matters by professional and qualified personnel for a defined project.
POSSIBLE SERVICES
- PQR development and preparation
- Risk Assessment
- Preparation of stability reports
- Complaint handling
- Batch Record Review
- Quality deficiency reports
- Release preparation
- SAP change management
- Change request control
- Review of marketing authorisation documents
- Qualification and validation
- Organisation of documents (signature, filing)
- Individual support for a QP
- Further issues in the day-to-day business
GMP TRAININGS
for a wide varietyof courses
GS Consulting SRLs offers a wide variety of GLP, GDP and GMP training courses, all of which can be delivered on-site or online, as well as in a city near you.
THIRD PARTY AUDITS
for pharmaceutical companies
Conducting supplier and service provider audits is a key requirement under the GMP rules and guidelines. A certificate from a supplier or service provider for critical products is not enough on its own. Qualification is required, and this can include an audit directly on site that must be repeated at regular intervals. When these audits are conducted by an independent 3rd party, being able to absolutely rely on the quality of performance is essential. Ensuring compliance along the entire relevant supply chain, nationally and internationally, is always the goal.
BENEFITS
- Qualification of service providers and suppliers by experienced GMP experts
- Ultimate quality of performance: GS Consulting srls has been qualified itself by customers numerous times
- Security and permanent relief for the customer
- Clearly defined approach, fixed audit processes
- Overcoming cultural barriers
- Detailed audit reports with concrete starting points and scheduled CAPA measures
- Ensuring the implementation of CAPA measures in the course of follow-ups
