We provide consulting services, both in GMP and ISO, supporting companies in the application of Quality Risk Management (QRM) and Quality by Design (QBD) to all business processes, paying particular attention to the management of the entire data life cycle.
We apply a method that is based on a clear and simple concept: having a precise vision of all the steps to be implemented to support companies and people in their path of excellence and achievement.
We start with the development of innovative analytical methods to support new products or new phases of an industrial process, we dedicate care to the review, implementation, processing, updating, monitoring and maintenance of the company quality system (QS), and we arrive at the validation and qualification of industrial plants.
- Computer system validation (CSV) and data integrity CSV IT audits;
- Third-party audits on suppliers;
- Internal audits, mock inspections;
- Documentary and regulatory audits;
- Pharmacovigilance audits;
- Audits on distributors;
- GDP audits.
- Follow-up audits and simulated inspections on suppliers of raw materials, packaging materials and services for pharmaceutical products, in accordance with applicable laws and GMP / ISO / ASTM guidelines;
- Development, implementation and maintenance of a quality system based on GMP guidelines for pharmaceutical excipients, integrating ISO (International Organization for Standardization) quality systems where they already exist, and creating new ones where they do not;
- Staff training on the Quality System and GMP guidelines for pharmaceutical excipients;
- Processing of all types of documents based on customer requests and specifications;
- Preparation of audit reports, corrective actions (follow-up) and preventive actions taken by the supplier;
- Qualification of suppliers based on risk;
- Identification of corrective and preventive actions for the elimination of non-conformities in accordance with the GMP (CAPA – Corrective and preventive actions);
- Assistance in the implementation of quality systems compliant with standards: ISO 9000 – Quality management; ISO 14000 – Environmental management, ISO 17025 – Quality management of testing and calibration laboratories. ISO 20000 – IT service management;
- Fulfilment of certification obligations;
- Assistance during the certification phase with the certification body;
- Verification of regulatory compliance of the company Quality System;
- In-depth study of the process and its capacity;
- Planning of experiments according to the DOE (Design of Experiments) method and production processes using PAT (Process Analytical Technology) to determine how each individual variable influences the result and characteristics of the finished product in order to reduce fruitless attempts and costs, increase the details of the information and strengthen both industrial chemical and mechanical processes to always meet the specifications;
- Construction and implementation of control boards;
- Analysis of errors and the effects of failures, with consequent analysis and risk management;
- Preparation of final reports at the end of the studies with evaluation of the results obtained;
- Design, modification and implementation of all Quality System procedures in compliance with the specific GMP standards;
- Updating and monitoring of the Quality System;
- Staff training on the Quality System;
- Development and management of setting/calibration/scheduled maintenance protocols for instruments used in production plants (refrigeration systems, air-flow laminar hoods, ovens, etc.), in storage areas (warehouses and benches under controlled conditions, etc.), and in laboratories (measuring instruments, etc.), in compliance with current Italian, European and international legislation.
- PAT (process analytical technology), NIR and Raman applications and libraries;
- Development of NIR-Raman applications for the real-time and non-destructive determination of product quality parameters with sample acquisition for the preparation of libraries;
- Determination of the limits of in-process specifications;
- Development of PAT and immediate release applications in accordance with ICH Q8, Q9 and Q10;
- Temporary laboratory personnel for QC laboratories (for chemical and microbiological tests);
- Temporary staff for the development of routine methods and tests in the areas of sterile validation and cleaning, chemical and microbiological;
- Transfer and Development Method Test;
- Transfer method;
- Development and validation of the entire method in compliance with the reference regulatory standards (ASTM, GLP, GMP, GAMP, ICH);
- Qualified consultancy for the development of tests in the chemical, biochemical and pharmaceutical fields (HPLC, NIR, UV, electrochemical) and advanced tests (NMR, thermal analysis, mass spectrometry, ESI-APCI, SDS-PAGE);
- Characterisation of enzymes and biological materials, samples with complex patterns;
- Identification and characterisation of unknown degradation products;
- ICH Stability studies;
- Forced degradation studies (stress test);
- Planning of appropriate stability studies for specific excipients and preparation of reports;
- Development and evaluation of stability protocols for all types of products and all climate zones;
- Updating ongoing stability protocols or marketing support for clinical trials;
- Development and validation of stability indication methods in accordance with ICH guidelines;
- Analytical determinations during the conduct of the study;
- Preparation of the final report at the end of the study with evaluation of the results obtained according to the statistical procedures provided for by the ICH Q1E guidelines (Evaluation of Stability Data);
- Preparation of protocols and analysis of data from the stability study in use;
- Preparation of interim reports during the course of the study;
- Preparation of protocols and analysis of data from the stability study in use;
- Preparation of interim reports during the course of the study;
- Statistical processing of stability data in accordance with ICH guidelines;
- Preparation of the stability report in accordance with ICH guidelines;
- Implementation of software to manage the planning of stability tests and related data in compliance with data integrity;
- Calibrations and Setting;
- Development and management of setting/calibration/scheduled maintenance protocols for instruments used at production plants (refrigeration systems, laminar air flow hoods, ovens), in storage areas (warehouses and benches in controlled condition, etc.), in laboratories (measuring instruments, etc.), in compliance with current Italian, European and international legislation;
- Carrying out tests and certifications of instruments or entire plants;
- Creation of the calibration logbook;
- Metrological chains* (with reference to the national SIT standard (Calibration Service in Italy) and international standards;
- Testing, certification, final inspection and preventive maintenance of pharmaceutical, environmental and chemical testing systems and laboratories;
- Study of the tolerance limits in the processes with consequent analysis of budget and balance of risk and uncertainty.
