Services

Our team of auditors is composed of qualified people with many years of (senior) experience who are able to organise visits according to the client’s needs and travel independently, including using local auditors if such a particular need arises or perform audits remotely if necessary. ILC therefore carries out:

1. GMP audits for the benefit of producers of Active Substances (APIs), Intermediates, Raw Materials, Excipients, in Italy, Europe, China, India and the rest of the world.
2. Audit of packaging materials (ISO 15378) and Medical Devices (ISO 13485) in Italy and Europe.

ILC supports companies/laboratories to obtain GMP production authorisation in accordance with the requirements of Italian Legislative Decree 219/2006. Our company can assist you with all aspects concerning the preparation of the authorisation application. In short:

• project initial assessment and Road Map preparation;
• organisation of the Quality Management System processes;
• support to the drafting and revision of SMF/VMP/;
• staff training;
• support in the preparation of documentation for obtaining authorisation as a pharmaceutical workshop;
• post-inspection follow-up until authorisation is obtained;
• remediation plan;

ILC supports its clients in maintaining GMP compliance, for example:

• consultancy for Quality Control;
• support in the drafting of SOPs and PQR and related training;
• consultancy for the preparation of Quality Risk Management;
• support in investigations for Root Cause Analysis;
• support in the definition of CAPAs;
• support for analytical validation, Cleaning Validation and process protocols;
• support for studies and stability checks;
• support for the submission of the Certificate of Suitability (CEP);
• Assistance in the development of synthetic chemical-pharmaceutical processes, in compliance with ICHQ11 and Q9 guidelines, in collaboration with specialised laboratories, from process evaluation to the drafting of validation protocols and Drug Master Files.

ILC supports companies/laboratories in the execution of Self and Mock Inspections for possible inspection visits by regulatory bodies or agencies.

Staff training for all aspects of GMP application in the production chain

• company courses
• individual courses
• introductory courses to patent reality

Training session can be arrange “on site” or via Webinars

ILC can assist the clients for the preparation of the following documentation for the APIs:

• preparation of module 3.2.S of the Drug Master File;
• responses to “deficiencies letters” and consultancy support for APIs;
• drafting of the “Quality Overall Summary”, form 2.3.S;
• preparation of module 3.2.S e-CTD (Extedo Software)

Support of activities in the field of drugs containing narcotic and psychotropic substances by our senior specialist staff.

ILC can support companies/laboratories to obtain the QMS (Quality Management System) according to ISO 9001-2015. Our company can assist you with all aspects concerning the certification path through:

• business processes’ initial assessment and Road Map preparation;
• support in creating the process flows and documentation (procedures, work instructions and related forms) required by the standard;
• staff training;
• support in the selection of the Certification Body and assistance during the certification audit;
• support during the follow-up phase, until the certification certificate is obtained;
• post certification assistance (maintenance/extension)

ILC supports all Economic Operators in the implementation of the QMS (Quality Management System) according to ISO 13485-2016 in accordance with MDR (EU) 2017/745 – IVDR (EU) 2017/746.
In short:

• gap analysis and feasibility study (document analysis, on-field observation, etc.);
• identification of the Organisation’s role in the life cycle of the medical device and internal and external processes;
• support in the development of process flows and documentation (procedures, work instructions and related forms) taking into account mandatory requirements;
• staff training;
• support in the selection of the Notified Body and assistance during the certification audit;
• support during the follow-up phase, until the certification certificate is obtained;
• post-certification assistance (periodic audits by N.B.)

Through close cooperation with the sister company Chemsafe, ILC offers the following specific regulatory toxicology activities:

• toxicological evaluation and Risk Assessment for impurities including nitrosamines;
• toxicological evaluation of Extractables & Leachables (E&L);
• “in silico” predictions (expert systems and statistical systems);
• PDE evaluations;
• OEL-OEB evaluations;
• risk assessment;
• hazard evaluations;
• occupational assessment;
• assessment of the application of SCC (Strictly Controlled Conditions) for the simplified registration of pharmaceutical intermediates isolated “in situ” and transported according to REACH Regulation.

All Expert reports issued are signed by our ERT® (European Registered Toxicologists).

In collaboration with specialised CROs ILC offers the setting up and monitoring (Study Monitoring) of pre-clinical and clinical studies (bioequivalence)

• assessment and design of the study package;
• selection of the most appropriate laboratory;
• monitoring of studies and setting the next steps;
• Expert report and summary, if required;
• signature of ERT® (European Registered Toxicologist)

Pharmaceuticals have become chemicals of emerging concern due to their potential to persist into the environment and to reach drinking water leading to an indirect human exposure. Looking at the overall incidence of pharmaceuticals in the aquatic environment, patient use of medicines (prescription and over the counter) is the principal pathway. Typically, a fraction (itself or metabolites) of the medicines taken by patients is excreted and enters environmental waterways. To a lesser extent, pharmaceuticals can enter the environment through improper disposal of medicines and from manufacturing discharges. Pharmaceutical companies are therefore acting to understand such a problem for their active substances.
ILC is can offer support with the following activities

• General consultancy by experienced eco-toxicologists and toxicologists
• ERA for Medicinal Products for human use as for EMEA/CHMP/SWP/4447/00 and following Q&A documents
• ERA for Medicinal Products for Veterinary Use as for VICH GL6 and VICH GL38
• Testing strategy setting and optimisation
• Testing laboratories selection and Study Monitoring
• Specific evaluation (PBT, vPvB, EDS, POPs)
• Risk assessment for different environmental compartments adn overall
• Expert Report signed by ERT (European Registered Toxicologist)
• Discussion with relevant Authorities

All topics/themes mentioned above can be the subject of online seminars (Webinars) held by our experts. Depending on the type of topic to be covered, our webinars last 1-3 hours. If you are interested in this training method please contact ILC at the following e-mail address:

a.conto@intuslegerechemia.com