Calibration, Qualification and Validation for Pharmaceutical Industry, Cosmetic, Drug Distributors.
ASSI Pharma is specialized in calibration, qualification and validation services for pharmaceutical, cosmetic industry, and sanitary products. Our services allow you to ensure that your facilities and equipment comply with applicable regulations (GxP, FDA, ISO-22716, ISO-13485, ISO-15378).
We put at your disposal our specialized technicians, trained and formed to work in the applicable regulatory environment to satisfy your needs.
ASSI as a leading company in Spain offers a wide range of services, all of them with a high quality, agility and adaptability to customer.
Our technicians will let you know about changes in regulations and help you to implement it in your company, as we have already done it with the last change on Good Distribution Practices (GPD) or the latest technical solutions to adapt computer systems to 21CFRpart11 standard or annex 11 GMPs.
Inquiry any quality service you may require to our specialized technicians. We will assist you.
Service Areas
- Pharmaceutical industry
- Cosmetic industry
- Agents involved in the drug distribution chain
- Sanitary products and medical devices manufacturers
- Primary condition materials manufacturer for pharmaceutical industry
- Qualified and specialized technicians
- Services compliance applicable regulations
- Access to your calibration and qualification plan though our CALIBWEB
- Integral Service
- Recognized company with 3 locations, Barcelona and Madrid, and more than 20 years of experience in your sector
- 100% flexibility and adaptability to customer needs
- Express Service
Commitment
Calibration
- Laboratory and Processes Instrument Calibration. Calibration variables:
- Temperature
- Humidity
- Pressure
- Weight
- Ph, Conductivity, Redox
- Flow
- Time
- Gas Analyzers
- Electrical Signals
- Dimensional
- Strength
- Others,…
- Equipment Calibration and Qualification for quality control in tablets: test of dissolution, hardness testers, disintegrating, friabilimeter, density metres.
- Our services: In Situ, Integral Service, BPO. Do you want more information?
- Calibration Plan Optimization based on risk management policies through QRM.
- Repair and maintenance service: preventive and corrective maintenance, repair and supply of instrumentation.
- Accredited (ENAC) Calibration. Temperature, pressure, humidity, volume and isotermal means. More information in ASSI Labs.
Qualification
- Manufacturing equipment Qualification (production and conditioning)
- Qualification of thermal equipment and sterilization
- Qualification of laminar flow cabinet, biological safety cabinet, isolators and extraction cabinets
- Analytical equipment Qualification
- Laboratory equipment Qualification
- Qualification plan preparation
- Qualification plan complete management
- Qualification plan optimization based on risk management policies through QRM
Qualification Activities:
- Qualification Plan (QP)
- User Requirement Specification (URS)
- Risk Assessment (RA)
- Protocol writing and execution DQ-IQ-OQ-PQ
Validation
ASSI Pharma offers validation services to pharmaceutical industry:
- Manufacturing and conditioning processes Validation
- Computerized system Validation
- Consulting in design and installation of computer systems and infrastructures
- Cleaning processes management
- Validation of analytical methods
- Infrastructure Validation (rooms, warehouses)
- Validation of Industrial Services (water, steam, compressed air, nitrogen,..)
- Services for Product Quality Review (PQR)
- Consulting and Training activities
- GMP, GDP, GLP regulation implementation and compliance
- ISO17378, ISO22716, ISO13485 regulations implementation and compliance
- 21 CFR part 11 (ERES) and GAMP5 regulations implementation and compliance
- Quality Risk Management (QRM) ICH Q8, ICH Q9, ICH Q10
Validation Activities
- Validation Plan (VP)
- Consulting in writing User Requirement Specification (URS)
- Risk Assessment Documentation (RA)
- Design review and traceability matrix (DQ)
- Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
- Protocol writing and execution DQ-IQ-OQ-PQ
- Final Validation Report
- Standard Operating Procedure (SOP) preparation