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Quality

Quality of Medicines
  • SAFE & EFFECTIVE medicines which meet the highest requirements to satisfy our customers and agents.
Premises & Facility
  • All internal walls in the manufacturing areas as a clean partitions according to the latest technologies in pharmaceutical field to be easily cleaned and maintained.
  • With mobile false ceiling easily maintained and clean to serve all facilities ducts.
  • All floors painted treated epoxy easily clean.
  • Building & Premises painting is carried periodically.
Personnel Hygiene
  • Employee hygiene is full controlled and continues training for hygiene practices with full instructions which obeyed by all employees.
  • Disposables garments (Overheads, overshoes, gloves, coats, and masks) are destructed upon using according to GMP regulations.
  • Protective garments full clean in the dedicated area.
Ventilation Systems
  • Through AHUs and HVAC system control, Heating, Ventilation and Air Conditioning is main system that is used to control the air temperature by controlling the air filtration and the moisture in the air in the manufacturing areas and WH.
  • Temperature is controlled to be in range of 18-25 Degrees centigrade in manufactured areas and NMT 30 Degrees centigrade in Storage areas.
  • Humidity is controlled to be less than 60 % RH in manufacturing areas and adjusted accordingly.
  • We have dedicated area for humidity control in the manufacture site NMT 20% for specific products.
  • Ventilation in manufacturing rooms, filling rooms, are recirculating type that filtered through AHUs system. Inlet air is filtered through HEPA Filters.
  • Our Ventilation process is depends on the recirculating type with about 10 % fresh air.
  • Dispensing & Sampling booths are provided with Terminal HEPA Filters. The whole WH area is well controlled with separated AHUs e.g. raw material storage area, Quarantine area, Finish area.
  • Our WH is equipped with a Refrigerator with temperature range 2-8 Degrees centigrade for sensitive materials which need conditional storage area.
  • The Q.C area is air – conditioned with totally separation unit for microbiological lab.
Water Systems
  • Highly advanced technology of Water Treatment to give the high standard purified water which used in the production areas & QC labs to maintain products in the required quality levels.
Maintenance
  • All equipment & Tolls are full maintained internally according to the maintenance plan to elongate machine life and to maintain the standardization of products quality.
Equipment
  • Riva is full equipped with highly advanced technologies for different dosage forms of pharmaceutical products e.g. All Powder to be filled are blended in SS 316L double – cone blenders with different capacities. All vessels have P.E. bags inside.
  • Oral dry suspensions are filled with All – Fill 10 automatic filling machine with contact parts made of SS 316L, with automatic unit for weight controlled, and closed by pilfer – proof aluminum closures.
  • Labeling is done manually automatically with an on – line batch legend over printer.
  • Hard Gelatin capsules are filled on an automatic capsule filling machines, with contact parts made from SS 316L.
  • Tablets are compressed on an automatic compression machine, with contact parts made from SS 316L. And coating process is available with Coating Machine, with contact parts made from SS 316L.
  • Capsules & Tablets packing is done on an automatic Blister packing machine, with embossing station for batch, manufacturing and expire date on each blister packing. Blisters are inspected 100% and packed using on line batch legend overprinted to print on the outer cartons, then sleeved and shrink – wrapped.
Quality Control
  • Full equipped to control all incoming and released finished products and make sure they are comply with approved specifications.
  • All incoming materials are sampled according to the approved sampling plan.
  • All Finish products are full analysis to make sure they are comply with approved specifications.
  • All RM & FN products processes based on standardized and methodologies prior to use in manufacturing or testing
Quality Assurance
  • Riva Pharma guidance, Riva is obey international standard guidelines e.g. WHO, Eudralex volumes and ISO 9001:2015 to comply with our customer markets need.
  • The policy of Riva Pharma Company is to require usage of qualified equipment & validated manufacturing process. All documents is reviewed & approved by responsible individuals & finally by a QA Manager & kept in file at the facility according to DC System.
  • A continuous QMS development and maintenance supported by recording, analysis and training programs.
  • Intact Investigation, complaints system with full implementation of CAPA system.
Calibration & Qualification
  • All Equipment and tools are full qualified by the agency and annually calibrated to maintain the standardization of products quality
R & D
  • High skilled R&D center that maintained with all upcoming new generation molecules; troubleshooting for current products for development and maintained effectiveness of products.
Pharmacovigilance (PV)
  • Riva is full committed with all PV guidelines and our products are full reported.
  • Monitoring and reporting the effectiveness and any adverse effects or side effects of Riva pharma products on the market in the general population and in hospitals.
  • Riva pharma continually assesses new and emerging safety data as it becomes available and undertakes regulatory action as appropriate.
  • Contributing to the safety profiles of existing drugs, pharmacovigilance activities help to improve the knowledge set and contribute to the breadth of epidemiological data.
  • It is a vital system for the advancement of medical understanding, future research and product development, which automatically improve in safety or understanding which ultimately lead to improvements in patient care.
  • Riva pharma encourages patients, carriers and other members of the public to report suspected adverse reactions (side effects) to us through officials way in contact us.
  • Add PV email address in contact us (pharmacovigilance@rivapharma.com).
Supply Chain
  • Our supply chain section cover all purchased materials from full qualified suppliers and according to MOH regulations.
  • According to annual forecasting plan divided into quarterly and monthly plan with efficiency up to 95%.
  • Riva Pharma Warehouses followed the GSP & GDP accordingly and with systematic diagrams for receiving and dispatching.
Production
  • The current Production Lines are for Beta lactams (Penicillin’s) which need special precautions of handling. Our current lines for producing hard gelatin capsules, dry powder for oral suspensions and tablets.
  • For Non beta Lactam, Cephalosporin’s molecules, and sterile dosage forms, Riva is collaborate with other Multinational companies and international companies.