To implement this slogan at Rivapharma, we strictly follow the GMP guidelines to produce SAFE and EFFECTIVE drugs, which meets the requirements and satisfy customers.
To achieve this goals:
• Prepare our procedures and documents according to GMP guidelines.
• Improve the performance skill of our employees.
• Have our production Operations documented and personal performing these operations are provided with work instructions.
• Evaluate suppliers, abhorred & local, according to their ability to supply approved materials.
• Inspect and test all reserved items.
• Monitor the production areas for cleanliness.
Premises and Equipment:
Nature of construction and finishes: The Construction is Ferro - concrete. All walls are plastered to smoothness and painted with epoxy. The ceilings in the manufacturing areas are gypsum board painted with washable emulsion paint. The floor in the production and storage areas are painted with epoxy anti fungal paints. In the Q.C .areas , floors are ceramic tiled. All lights in the area are enclosed.
There are adequate washing, changing and rest room facilities. Uniforms, Protective garments, headaches, latex gloves and Foot - Wear, as required, are provided and are used by the employees. Clothing fabric is either cotton or polyester blend. Eating, drinking, chewing and smoking are strictly prohibited in manufacturing areas. Workers suffering from illness as colds, skin rashes open lesions or cuts in skin, should report and are excluded from working in the clean areas till cured.
Ventilation Systems in Manufacturing areas:
Ventilation in manufacturing rooms, filling rooms, are recirculating type. Air is filtered through ceiling mounted filters. Inlet air is filtered through 5 micron filters. Temperature is controlled to be less than 22 Degrees centigrade.
Ventilation is of the recirculating type with about 10 % fresh air make - up. Humidity is controlled to be less than 45 % RH in manufacturing areas. The raw material storage areas are air conditioned. Dispensing rooms are provided with 5 microns - filtered recirculating air mobile equipment. The Q.C area is air - conditioned.
The main potable water supply is from local corporation. The potable water is passed through demineralization unit before use in washing.
The preventive maintenance of building and premises including painting is carried out periodically. Protective fighting of rodents and insects is done through specialized contractors.
Oral dry suspensions are filled with All - Fill 10 automatic filling machine with contact parts made of SS 316, weight controlled, and closed by pilfer - proof aluminum closures. Labeling is done manually with an on - line batch legend over printer. Hard Gelatin capsules are filled on an automatic capsule filling machine, with contact parts made from SS 316. Powder to be filled are blended in SS 316 double - cone blenders. All vessels have P.E. bags inside. Capsule packing is done on an automatic Blister packing machine, with embossing station for batch, manufacturing and expire date on each blister packing. Blisters are checked manually and packed using on line batch legend overprinter to print on the outer cartons, then sleeved and shrink - wrapped.
Quality control is independent of production All incoming materials are sampled according to the sampling plan and are given a unique analytical ref. number: The analysis is carried out by analysts. All analytical work is recorded in Analytical Data Sheets which are checked by Q.C. manager. Retention samples are held for all raw materials and finished products for at least one year after the shelf life of the product.
Q.C. ensures the implementation of quality control procedures which include:
• Maintenance of reference and working standards.
• Release or rejection of materials.
• Monitoring stability of products.
• Investigation of complaints.
• Validation and instrument calibration.
• Environmental control.