Validation of pharmaceutical equipments has basically two goals:
- Tools of the Industrial Area in order to show the adequacy of its facilities, equipments and the suitability and reliability of its manufacture and control processes.
- The pharmaceutical sector is a regulated sector and the different regulatory agencies (AEMPS, EMA, FDA, ANVISA…) are regulating these activities of qualification and validation through specific rules and guides of specific compliance. These activities of qualification and validation must be correctly done and documented in order to get the approval of a facility by the agencies.
Validation of pharmaceutical equipments: management and organization.
The management and organization of the qualifications and validations of a plan are made following these documents:
Validation Master Plan
URS (Users Requirements), FS (Functional Specifications), DS (Design Specifications
Quality Risk Management strategies
Risk assessment: facilities, equipments and processes.
FAT, SAT, Commissioning stages for utilities and equipment
DQ/IQ/OQ/PQ of the following equipment’s, utilities or systems
Qualification of utilities HVAC, PW, WFI, PS, CIP/SIP, Compress air, Vacuum.
Qualification of process and packaging
Qualification of Analytic Equipment: UPLC, HPLC, NIR…
Validation of processes of sterilization (if necessary)
Validation of Analytic Methods (physiochemical and microbiological)
Validation of computer Processes. ERP. LIMPS. SGA. SCADAs, PLCs.
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