Quality Management

BAKHTAR BIOSHIMI pharmaceutical company quality management includes all measures designed to ensure quality of the products and their stability for use of patients.

1: Training
Since all of our employees are major assets in our progress to date and upcoming years, BBpharmaco offer unique opportunities for personal developments, growth and career achievements. We are a rapidly growing company with high ambitions and prospective opportunities. We believe in us and encourage training transfers and potentially promotions as part of developing our employees within the integrated management system in various areas, including cGMP, GLP, GSP, GEP and ISO14000, ISO 9001, environmental education, health and safety education, specialized scientific and technical training for personal recruitment, prospective and current employees.

2: Internal inspection and supplier evaluation

  • Internal inspection
    In order to gain assurance, Internal inspection guidelines in accordance with the principles of GMP has been provided. These inspections which get periodically and regularly applied will assess the effectiveness and capability of our quality management system. Personnel requests, facilities, equipment, documentation, quality control, distribution of products, procedures for dealing with complaints, Recall and self-inspections in order to compliance with the principles of quality assurance at the proper intervals are conducted.
  • Supplier evaluation
    Initial and repeated evaluation of service providers and raw material suppliers for company in order to assurance of their adaptions is enforced according to GMP requirements and specifications. Furthermore their impacts on company productions, labors as well as on environmental, health and safety performance get assessed.

3: Documentation:
Product documentation is an important part of the quality assurance system to ensure full compliance with GMP requirements. The Company uses various types of dossiers that are fully defined in the Quality Management System. Documentations are created, monitored, maintained and histories of all activities that directly or indirectly impact on various aspects of the quality of pharmaceutical products are recorded.

4: Product release and supervising the production and quality control laboratory:
In Bakhtar Bioshimi quality control laboratory assure that no raw material is free to be used in production, no product is free for sale unless they meet the specification of our quality control laboratory. In our company product quality assurance and delivery release for sale are not acceptable unless they get evaluated by quality control laboratory.

5: Validation, verification and calibration:

  • Calibration:
    Quality system has considered measure for calibration, verification and monitoring of measuring equipments and has provided processes to monitor and evaluate the accuracy of instrument which are directly or indirectly dealing with products quality.
  • Validation and verification:
    One of the main purposes of quality system is validation of processes and qualification of all instruments and systems. Quality, safety, and efficacy are designed into products. All critical steps in the manufacture of a product must be identified and validated. Remarkably change of facilities, equipments and processes that may affect product quality become validated. Risk assessment method used to determine the scope and level of validation. Key elements of a comprehensive plan get recorded in a validation master Plan (VMP).

6: GMP

Is a part of quality assurance that ensures the products consistently meet requirement of current GMP standard and intended specifications. In BAKHTAR BIOSHIMI CO GLP, GEP, GDP & GSP, GCP and GAP standard have been established and are consistently being updated.

7: Formulation and Drug Development
Is a key source in ensuring qualified products at the company. The primary approach of research and development in pharmaceutical industry is based on the development and presentation of new and effective drugs that can improve the quality of life of a wide range of patients. The main activity of the department of research and development of our company is development of new products, optimization of previous product formulations, as well as developing and validating methods for the quantitative analysis, qualitative assessment and clinical investigations on the designed formulations.

8: Quality Risk Management:
Risk management is other systematic process of quality assurance to assess, control, communicate, inform and review the risks related to the Company’s products and processes. Quality risk management gets carried out either prospective or retrospective. It also runs on the basis of scientific knowledge and experience obtained from ongoing processes. Finally the ultimate goal of quality risk management is assurance of patient safety.

9: changes Control:
It is official part of quality assurance that processes by representatives and qualified experts in the related fields and relevant sectors to survey the potential or proposed changes to investigate the impact of these changes on the structure and validated systems, equipment and processes. The purpose of change control is to determine whether change made necessitate a revalidation process or cause any risk upon product quality.

10: Warehouse:
Appropriate mechanisms have been done to ensure that the storage of goods at the beginning of being raw materials till finished products is performed in a way that maintains their qualities throughout life cycle. The most important rules and procedures in BB pharmaco that are in accordance with good storage regulations & guidelines consist of following subjects: Monitoring and Mapping the temperature and environmental conditions, product maintenance, personnel, buildings and facilities, cleanliness, hygiene guidelines, complaints and recall guidelines, Post Marketing Quality Control (PMQC)

11: Complaint and product recall
All complaints and other information concerning a probable defect in product are thoroughly assessed on the basis of written procedure by the quality assurance department. So, for such unlikely condition to happen a system called Recall process is designed and is able to quickly and effectively collect defective products from market.

12: Products Quality review
Regular and periodic review of the quality of manufactured products is performed. Validation of the robustness of current manufacturing methods and appropriateness of specifications for raw materials and finished products would be enforced. Product quality review is documented as annual product quality reviews (APR). Then with a revision, summary of the necessary corrective actions or preventive actions (CAPA) and validation comes up on surveyors.

13: Regulatory affairs:
In order to insurance of the safety and efficacy of manufactured drugs, the solutions for acquisitions, notifications, updating the rules, regulations and technical knowledge have been used.

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