Pharma & Biotech

Challenges of the industry

The challenge of the pharmaceutical sector is to move more and more towards new forms and new treatments while ensuring that innovative manufacturing processes are implemented and that quality and regulatory issues are respected.

Below you will find how Alispharm can support you in this journey.

Quality Assurance

Operational Quality Assurance
• Processing Quality Events / NC / CAPA / Change Control
• Coordinating quality action plans
• Quality management with suppliers, production and laboratories

Quality Management System
• Creating and reviewing the QMS according to the BPF/GMP
• Preparing audits and managing post-audit answers
• Training, awareness and supporting staff in the quality process

Qualification Validation

Validation of Computerized Systems
• Validation of computerized systems (GAMP5 environment, 21CFR part11)
• ERP, GED, automated and embedded systems
• Integration, software, unit and non-regression tests
• Data Integrity Projects (traceability, access, audit trail)
• VMP, protocols, tests and reports

Validation of Automated Systems
• Production and Laboratory Systems (PLC, IHM) and SCADA Supervision
• Audit trail, access management, data saving, back-up, restore
• VMP, protocols, tests and reports

Qualification of Equipments
• Equipment risk analysis // AMDEC – PFMEA
• Strategy of qualification
• CQ, IQ, OQ, PQ
• Protocols, tests and reports
• Tests execution
• Non-conformities management

Process Validation
• Process risk analysis
• Worst cases
• Identification of CPP and CQA
• Risk strategy
• Protocols, tests and reports
• Tests execution
• Non-conformities management

Regulatory Affairs

Regulatory Affairs
• Marketing authorization applications (MAA) files
• Modules 2, 3, 4 and 5 (CTD and e-CTD format)
• Responses to health authorities of different countries

Pharmacovigilance & Clinic
• Management of adverse events, adverse reaction (AR) reports
• Writing PV reports (PSURs)
• Product benefit/risk management

Quality Control

Quality Control
• Analytical and microbiological development and validation
• Analysis of test results, management of OOS
• Data integrity project, LIMS installation


Industrial Transfer
• Management of inter- and intra-site transfers (complete lines or equipment relocation)
• Scale up, scale down
• Analytical transfer, technological transfer

Commissioning & Engineering
• User needs, drafting the requirements specifications, defining the specifications
• Purchase and installation of equipment, automated systems, utilities, premises
• Suppliers, installation and testing management

Related articles

Ready to tackle your challenges in Pharma & Biotech?

Discover our content feed