Quality QA-QC

We provide consulting services, including staffing, both in the GMP and ISO environments, supporting companies in the application of Quality Risk Management (QRM) and Quality by Design (QBD) to all company processes, paying particular attention to the data to be managed throughout its life (life cycle management).
From the development of new analytical methods supporting new products or new steps in an industrial process, from the review, implementation, elaboration and updating, monitoring and maintenance of the company’s Quality system (QS), to the validation and qualification of industrial plants. We conduct audits and implement new supplier qualification processes and we provide outsourced staff to assist the quality team in its daily document management activities with the support of senior consultants ready to give their expert advice.

  • 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 mock inspections on suppliers of starting materials, packaging materials and services for pharmaceutical products, in accordance with the existing laws and GMP/ISO/ASTM guidelines;
  • Elaboration, implementation and maintenance of a Quality system based on the GMP guidelines for pharmaceutical excipients, integrating ISO (International Organization for
    Standardization) quality systems, where they exist, and brand new ones, where they do not;
  • Training of personnel on the Quality System and the GMP guidelines for pharmaceutical excipients;
  • Elaboration of all kinds of document on the basis of the customer’s requests and specifications;
  • Elaboration of audit reports, corrective actions (follow-up) and preventive actions taken by the supplier;
  • Supplier qualification by risk
  • Identification of the corrective and preventive actions for eliminating non-conformities in accordance with the GMPs (CAPA – Corrective and preventive actions);
  • Assistance in implementing quality systems complying with the 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 the certification obligations;
  • Assistance during the certification phase with the certifying authority;
  • Verification of the regulatory compliance of the company’s Quality System;
  • In-depth study of the process and its capacity;
  • Planning of the experiments in accordance with the DOE (Design of Experiments) method and the manufacturing processes using PAT (Process Analytical Technology) to determine how each individual variable influences the result and the characteristics of the finished product with a view to reducing fruitless attempts and costs, increasing the details of the information and strengthening both the chemical and the mechanical industrial processes so as always to meet the specifications;
  • Construction and implementation of control cards;
  • Analysis of errors and the effects of faults, with consequent risk analysis and management;
  • Elaboration of final reports at the end of studies with assessment of the results obtained;
  • Design, elaboration and implementation of all the Quality System procedures in compliance with the specific GMP standards;
  • Quality System updating and monitoring;
  • Personnel training on the Quality System;
  • Implementation of GMP staff training management systems
  • Elaboration and management of setting/calibration/scheduled maintenance protocols for instruments used at the production plants (refrigerator systems, laminar airflow hoods, ovens, etc.), in the storage areas (controlled-condition warehouses and counters, etc), in laboratories (measuring instruments, etc), in compliance with the Italian, European and international legislation in force;

PAT (process analytical technology), NIR and Raman applications and libraries

  • Development of NIR-Raman applications for the real-time and non-destructive determination of the quality parameters of the products with acquisition of samples for preparing libraries;
  • Determination of the in-process specification limits;
  • Development of PAT and Immediate release applications in accordance with ICH Q8, Q9 and Q10
    3.2 Temporary laboratory personnel for QC laboratories (for chemical and microbiological tests)
  • Temporary staffing for the development of methods and routine tests in the chemical, microbiological, sterile and cleaning validation areas

Test development and transfer method

  • Transfer method
  • Development and validation of the entire method in accordance with the reference regulatory standards (ASTM, GLP, GMP, GAMP, ICH,);
  • Qualified consulting for the development of tests in the chemical, biochemical and pharmaceutical (HPLC, NIR, UV, electrochemical) areas and advanced tests (NMR, thermal analysis, mass spectrometry, ESI-APCI, SDSPage)
  • Characterization of enzymes and biological materials, samples with complex patterns;
  • Identification and characterization of unknown degradation products;

 ICH stability studies

  • Forced degradation studies (stress testing);
  • Planning of suitable stability studies for specific excipients and elaboration of the reports;
  • Elaboration and assessment of stability protocols for all types of products and all climatic zones;
  • Updating of the on-going stability protocols or marketing support for clinical studies;
  • Development and validation of stability-indicating methods in compliance with the ICH guidelines
  • Storage and analysis of active ingredients and finished products in compliance with the ICH guidelines
  • Analytical determinations during the conduct of the study;
  • Preparation of the final report at the end of the study with assessment of the results obtained in accordance with the statistical procedures set out in the ICH Q1E guideline (Evaluation of Stability Data);
  • Preparation of protocols and analysis of the in-use stability study data;
  • Preparation of intermediate reports during the course of the study;
  • Statistical processing of the stability data in accordance with the ICH guideline
  • Preparation of the stability report in accordance with the ICH guideline
  • Implementation of software for managing the planning of stability tests and their data in compliance with data integrity

Calibrations and settings

  • Elaboration and management of setting/ calibration/ scheduled maintenance protocols for instruments used at the production plants (refrigeration plants, laminar airflow hoods, ovens,
    ), in the storage areas (controlled-condition warehouses and counters, etc), in the laboratories (measuring instruments, etc), in compliance with the Italian, European and international legislation in force;
  • Performance of tests and certifications of the instruments or entire plants;
  • Creation of the calibration logbook (register);
  • Metrological chains* (with reference to the national SIT (Servizio di Taratura in Italia) standard and international standards;
  • Testing, certification, final inspection and preventive maintenance of testing systems for pharmaceutical, environmental and chemical test laboratories;
  • Study of tolerance limits in processes with consequent uncertainty budget analyses.