Strategies for the fulfillment of GMP and GDP regulations
We help organisations to implement a quality system which is based on a broad strategic vision to fulfill GMP and GDP regulatory needs in each of your activities in order to eliminate risks, optimize resources and be prepared for inspections or audits, be they by clients and/or regulatory entities.
Regulatory compliance in the manufacture of API, pharmaceutical forms, bio-technology, medical distributors.
From our global fulfillment approach for an organisation down to the solution of incidents detected by either a regulatory agency, an internal audit or even your own client, with this wide-range of possibilities available to us we are able to formulate an offer to cover your real needs.
- Review of your organisation´s current level of regulatory fulfillment.
- Implementation of a plan for improvement.
- Solutions to incidents detected by audits/inspections.
- Update and application of the latest regulations.
Quality by Design (QbD)
Development of policies and a methodology for the integration of QbD into your organisation:
- Definition of QbD procedures from R&D through to Production.
- Identification of a Quality Target Product Profile (QTPP).
- Identification of Critical Quality Attributes (CQA) and Critical Process Parameters (CPP).
- Application of Design of Experiments (DoE).
- Implantation of statistical tools for the analysis and identification of tendencies.
Qualification of equipment and installations
The need to have available qualified equipment and installations as an element to demonstrate that a suitable manufacturing process is inherent to every process of regulatory fulfillment in the manufacture of API, final pharmaceutical forms and bio-technology.
We can collaborate to develop:
- Master Validation Plans.
- Qualification Protocols (Reports).
- Qualification of production equipment.
- Qualification of installations.
- Qualification of services.
- Cleanliness Validations.
- Strategies for the performance of PQR, such as revision tools and continuous improvement.
Application of Good Distribution Practices (GDP)
The growing need for regulatory fulfillment now extends to the distribution of medicines. In this respect we can collaborate in:
- Review of the level of GDP compliance.
- Validation of IT Systems for the control of distribution that assure traceability.
- Audits of distribution companies.
- Identification of the critical points in your distribution process.
- Qualification protocols for transport companies.