Cosmetic industries

Research & Development

Research projects of new assets
Tests
Patent filing (IP)
Scientific monitoring

Development of new formulas:
Development and optimisation of the formula
Analytical development
Galenic development
Stability studies, packaging

Industrial development:
Implementation and/or optimisation of the manufacturing process
Scaling up
Technological transfer

Quality Control

Optimisation and Validation of analytical methods
Physico-chemical and microbiological controls of PM, IP, PF and packaging items
Implementation of the control methodology (sampling, frequency, retention of samples, etc.)
Control and monitoring of product stability (on-going stability)
Management of deviations linked to the laboratory activity
Analysis of anomalies, OOS and OOT and follow-up of investigations
Drawing up protocols and analytical reports
Carrying out inter-laboratory Gap analysis/ methods
Review of the analytical part of the batch dossier
Data integrity
Deployment of the requirements of the specifications: GMP cosmetics, etc.

New works and maintenance

Management of technical affairs
Coordination between the different departments (quality, purchasing, production, finance, etc.)
Project monitoring from the definition of the URS until the commissioning of equipment/ utilities / buildings)
Commissioning/FAT/SAT/QI/QO/QP
Implementation of the maintenance strategy (curative, preventive and ameliorative)

New works & revamping
Design of manufacturing, packaging, cleaning or serialisation lines
Design of utilities and/or buildings

Supply Chain

Analysis and monitoring of transport conditions (logistical complaints, temperature excursions, etc.)
Coordination of recalls/ batch withdrawals
Change control and CAPA monitoring at the level of the distribution chain
Establishment/modification of distribution channels
Support for depositaries
Qualification of the suppliers

QHSE Technical Supervision

Extension projects, maintenance, shutdowns
Creation of safety receptions, prevention plan, fire permits and management of the DI system
Verification of the qualification of the participants, the conformity of the equipment
Occupational Risk Assessment
Assistance in setting up and monitoring means of protection (EPI/EPC)
Control of the good practice of the applicable standards and instructions (auditing)
Specific Missions:
– ISO14001:2015, OHAS18001:2007, ISO45001:2018, MASE
– ICPE dossiers, chemical risk assessment, ATEX study

QA system

Implementation and Optimisation of the SMQ
Deployment of normative requirements ISO 22 716, etc.
Identification and mapping of processes
Preparations for inspections (ANSM, FDA) and for internal audits
Document management (Writing of SOP, WI, quality manual …) and implementation of GED
Risk management approach
Training
Audit, gap analysis
AQ Suppliers, supplier audits, subcontractors
Normative and regulatory regulation
Identification and drafting of procedures, work instructions and operating methods

Operational QA

Management of deviations, anomalies and non compliance
Technical research
CAPA Management
Change Control Management
Customer Complaints management
Management of production documentation, validation procedures, instructions, release of batches
Creation of Product Quality Reviews
Environmental follow-up (ZAC…)
Implementation of management tools (access, Excel, specific software)
Release of batches

Qualification

Qualification and validation :
initial, retrospective and periodical
Qualification of Premises and utilities
Equipment qualification (production, packaging, control, laboratory)
Management and validation of the V-cycle:
Definition of user needs (URS)
Drafting specifications
Traceability matrix, risk analyses, Validation Master Plan
Carrying out tests, and writing reports for the phases of QC, SAT and FAT, QI/QO/QP
Validation Report and put into production

Validation

Validation of manufacturing processes (liquid, pasty and semi-pasty forms)
Cleaning validation (manual, semi-automatic, CIP) or sterilisation
Analytical, physicochemical & microbiological method validation
Validation of storage and transport

VSI – VSA

Data Integrity
Automated and computerised systems
Global and local systems
Qualification of infrastructures
Systems involved
– LIMS : Laboratory systems
– MES : Production systems
– ERP (SAP, SAGE X3,…)
– Software
– Excel/VBA macro files

Consultation and maintenance of dossiers

Regulatory regulation
Answers to questions from regulatory authorities
Control of labelling information and various communication media
Validation of allegations
Constitution and publication of the Product Information Files and European Legal Files
Notification of products on the internet portal of the European Commission
Technical and regulatory monitoring of products
Management of Export dossiers
Validation of formulas in accordance with standards and regulations
Validation of packaging elements

Registration and Submission

Definition and implementation of a technical-regulatory strategy

Cosmetovigilance

Collection, entry and management of PV data
Interface with users, healthcare professionals, authorities and internal partners

Implementation of clinical studies

Drafting of key documents
Submission of documents to the relevant authorities
Managing amendments
Development of test protocols
Clinical research
Data Management
Biostatistics
Managing the clinical project
Coordination of clinical trials

Selection and monitoring of CRO

Benchmarking of a pre-defined panel
Logistics of research centres