Beta Healthcare International has a well established Quality Management System that ensures that the products that reach the consumer are safe, efficacious & of high quality. The quality system is driven by a competent registered Pharmacist who is the Head of Techinical/QA Department. All the other personnel in this department are well educated with vast experience in this field. Under this department there is the cGMP & Documentation ,Quality Control , In-process quality control, Regulatory Affairs, Registration.
The cGMP & Documentation officer ensures that all procedures in all the departments and records are adhered to and evaluated as required & that all corrective and preventive actions are implimented. The different processes are documented in the form of Standard Operating Procedures (SOPs). cGMP & Documentation officer also ensures that all equipments, processes and analytical methods are vaidated.
Beta Healthcare International has a well established and equiped Quality Control Laboratory. It is well equipped with all the necessary equipments such as High Performance Liquid Chromatography (HPLC), UV/Visible Spectrophotometer, FTIR Spectrophotometer, Dissolution testing, among others. The QC ensures that sampling and testing all raw materials, packaging materials ,intermediates and the finished products are tested as per good laboratory practices and as per pharmacopial specifications. Sampling and testing of all the materials is done on each batch & the release of materials for use in production and the release of products for sale is done by the registered company pharmacist after ensuring that the products all required specifications at all the stages.
The In process quality control are done on the production floor as the manufacturing process is going on to ensure that the products meets required specifications. Line clearance is also mandatory as per Good manufucturing Practices.
New Product Development is the life line of a company & Beta Healthcare International invests well New Products to ensure that the products meet the requirements of our esteemed customers. A vigorous due diligence is done on all our new products to ensure that we only have quality products. To this end, the Technical team is charged with the responsibility of ensuring that the suppliers and the contract manufacturers are all (GMP) Compliant.
Beta Healthcare International aslo ensures that the requirements of different regulatory authorities in the different Sub- Sharan African countries where Beta Healthcare International products are sold are fulfilled & that the products are registred in all the markets.
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Safety Health & Enviroment Management
Click here to read Our SHE POLICIES
Click here to read Our Aspen Environmental Managemental PrinciplesEco-balance is a key issue in the current discussions and in saving our planet.
Depletion of fossil fuels CO2 emissions and global warming are a threat to our ecologic and economic balance.
Our company aims to contribute to ensuring eco-balance by taking initiatives towards energy saving and low carbon emissions.
Environmental management protocols are being developed in accordance with ISO 14001 to enable the company to participate in Carbon Disclosure Project (CDP) in a near future.
Beta Healthcare takes water as a resource which is limited and therefore continually puts in measures to conserve water. It comes up with Environmental Management Programmes with set targets as part of its annual objectives in Water Conservation.
Process waste water is treated to ensure set parameters are met before the water is discharged into the public sewer as per the requirements of EMCA Water Regulations of 2006. The company has in place a waste water treatment facility with enough capacity to treat the waste water to the required quality as required under the Water Quality Regulations.
The company compiles its energy consumption for use in calculating its carbon emission equivalent. There are measures put in place to reduce carbon emissions as part of the company’s Annual Environmental Management Programmes.
Beta Healthcare has in place an energy policy. Energy audits have been carried out and energy conservation programmes initiated as per requirements under Energy Act. The energy conservation programmes are taken as part of annual Environmental management programmes and objectives are set with targets to be achieved in energy use. Continuous monitoring of the programmes is done to ensure achievement of the set objectives and targets.
Air quality measurements are done on an annual basis to ensure that what is emitted is within required regulatory requirements. Exhaust emissions from the boiler, generator and industrial trucks are measured to ensure that emissions levels are within specified regulatory limits as provided under EMCA-Air Quality Regulations, 2015. Measurements are done for particulate and VOCs in the work stations to ensure personnel are working in a conducive environment as per the requirements under Occupational Health and Safety Act-Hazardous Substance Rules and WHO guidelines.
Structured waste management processes are implemented. Continual improvement initiatives are undertaken on the waste handling procedures.
As per the Cap 244, the Pharmacy and Poisons Act, Laws of Kenya, all pharmaceutical wastes must be handled responsibly owing to the security risk around pharmaceutical products. The pharmaceutical waste and other hazardous wastes are handled in accordance with the Environment Management and Coordination Act (EMCA), Waste Regulations of 2006.
The wastes are segregated, recorded, properly stored before they are disposed off. All wastes are disposed off using NEMA approved waste handlers for transportation and disposal sites. Waste recycling and reuse opportunities have been implemented for non-hazardous waste.
The central waste yard at Beta has been designed for more efficient handling and compliance to the Waste Management Regulations and to the Aspen standards for waste management.
Beta Healthcare has under taken a comprehensive Hazard Identification and Risk Assessment and kept in place mitigation measures for the identified risks. This has been done to proactively prevent incidents at the workplace. All incidents are investigated and corrective actions proposed and implemented to prevent reoccurrence. Key performance indicators are in place to measure SHE performance in terms of accident rates. The company aims at having minimum cases of accidents in line with its SHE policy.
Beta Healthcare takes compliance to regulatory requirements as key to its operations. It has a legal register which is updated quarterly and a legal unit which aids in updating the company on legal issues. Legal audits are done annually to check the level of compliance and propose corrective measures for any noncompliance noted.
As part of its business continuity strategy, Beta Healthcare has identified the emergency situations it anticipates and kept in place emergency response plans. It has procedures for response to the emergencies and also tests these procedures periodically to ensure adequate preparedness. All employees are trained on steps to take during emergency situations.
Measures kept in place as part of emergency preparedness include having a fire safety policy in place.
