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The Production Department is responsible for the manufacture of our intravenous infusions. The Production block has been designed in accordance with the requirements of WHO Good Manufacturing Practices for Sterile production.
Due to the critical nature of our products which are required to be sterile, there are adequate measures in place to ensure that microbial and particulate contamination of the various rooms and the products are kept to the barest minimum. The design also ensures logical flow of materials and personnel.
Clean rooms for the manufacture of these large volume sterile products have been classified according to the required level of environmental cleanliness both at rest and in the operational state. Since these products are to be terminally sterilized, the filling operations are undertaken in a Class 100 (Grade A)
Unidirectional airflow workstation, a Non-PVC Form-Fill-Seal machine against a Class 10,000 (Grade C) background.
The process of infusion manufacture commences with the production of water for injection (WFI) which serves as the main vehicle in with other raw materials are dissolved. The new plant has an installed Water treatment Plant that combines a Double–Pass Reverse Osmosis, Electrodeionization and Ultrafiltration mechanisms in the production of WFI.
Following weighing of the specified quantity of raw materials, mixing is carried out with the WFI to produce concentrate which is subsequently diluted to produce a final homogenous solution. The latter is then pumped for filling in Polypropylene bags and sealed by the Form-Fill-Seal process. Autoclave sterilization of the pre-filled infusion bags are then carried out, the products are inspected for visible particles and are finally packaged in polythene (as secondary package) and then in cartons.
This involves three main stages namely, Label printing & container molding; container filling; and container sealing.
VISUAL INSPECTION
Packaging 1
The Quality Assurance (QA) department is responsible for maintaining total quality of systems and products as per WHO cGMP requirements. The Quality Assurance manager ensures that the Quality Management System of Sanbao is implemented effectively to achieve our quality policy and objectives. Major responsibilities of the QA department include the following:
Our Quality control department has experienced, competent and technically qualified personnel to shoulder various activities of the department. The Head of quality control has enough experience in Quality control functions, as applicable to pharmaceutical formulations.
Quality control is responsible for sampling and analysis as per approved specifications.
Release/reject authority for all raw materials, packing materials, intermediate products and finished products lie with quality control only, but final release authority for product lies with Quality assurance. It is ensured that the quality control function remains independent of other departments and is under the authority of the Quality Control Manager.
The laboratory has been designed and equipped with facilities for chemical, instrumental, microbiological and stability testing. The QC laboratory has been set up in accordance with WHO GMP requirements and it is separate from the Production block.
Is responsible for the distribution of our products. The Marketing Manager ensures that products are distributed in accordance with the principles of Good Distribution Practices. Sanbao has an unrivaled track record of meeting customer demands by supplying products promptly to the satisfaction of our clients.
Our production plan also ensures that products are always available and in sufficient quantity to meet market demands.
Sanbao’s intravenous infusions are distributed to Regional Medical Stores, various private and government hospitals, clinics, health centers as well as Pharmacies. Sanbao is currently the leading supplier of intravenous infusions in Ghana.
Sanbao has recently set up a pharmacovigilance department to ensuring that the company meets its legal obligations in the Public Health Act, 2012, Act 851 Section 125 for monitoring of the safety of the product marketed in Ghana.
A Qualified Person for Pharmacovigilance (QPPV) heads this department and ensures that products manufactured, imported and marketed by Sanbao are safe for the consumer. The PV team has knowledge of applicable Ghanaian safety monitoring legislation and guidelines and international standards for Pharmacovigilance, trained and certified by WHO and Ghana FDA.
The responsibilities of the qualified person responsible for pharmacovigilance includes but not limited to the following:
- Act as a single point of contact for the Authority on all matters relating to pharmacovigilance and safety of marketed products including pharmacovigilance inspections.
- Establish and maintain a system which ensures that information about all suspected adverse drug reactions/events which are reported to Sanbao, is collected, collated, processed and evaluated and forwarded to the Authority in line with the timelines stipulated by the Authority.
Prepare the following documents for submission to the Authority.
- Adverse Drug Reaction reports
- Periodic Safety Update Reports (PSURs)/Periodic Benefit-Risk Evaluation Reports (PBRER), when necessary
- Company-sponsored pre- and post-registration study reports
- Risk Management Plans and Ghana Specific Risk Management Plan when requested by the Authority
- Ensure that any request from the Authority for additional information deemed necessary for the evaluation of the risk-benefit ratio of a marketed product, is provided to the Authority promptly and fully.
- Oversee the safety profiles of the company’s marketed products and any emerging safety concerns.