The main purpose of the Quality System of Replek Farm Ltd Skopje is to provide certainty that the products are manufactured in accordance with the Marketing Authorisation requirements, i.e. that the products meet the requirements for safety, efficiency and security.
QUALITY MANAGEMENT SYSTEM
The quality is achieved following the basic principles of Good Manufacturing Practice (EU GMP), the guides of ICH (Internacional Conference on Harmonization), PIC’S (Pharmaceutical Inspection Co-operation Scheme), WHO (World Health Organization), and the international standards (ISO).
In achieving the main purpose, a Quality Assurance System was designed, implemented and certified, which, beside the EU GMP – Good Manufacturing Practice includes The Enviromental management standard ISO 14001: 2004 (first certificate from 03.2008, issued by SGS – Switzerland)
By applying of these Standards, process management is assured according to the status of the famous Deming’s PDCA cycle (plan-do-check-act), and the identified environmental aspects (noise, waste and respirable dust) are regulary monitored and evaluated and the consumption of energy, water and other natural resources is rational.
The realization of the defined objectives for quality and environment is evaluated on an annual basis, and new, higher objectives are being defined which contributes to the continuous promotion of the existing Quality and Environment Management System.
The Statement for the Policy of Quality and Environment by the highest Management defines the main principles and the general determination of Quality as basis of the business philosophy of Replek Farm Ltd Skopje, i.e. for environmental protection and preservation, as moral commitment towards the current and future generations.
The Management develops and maintains ambience of cooperation, mutual respect and trust among the employees, based on a team work in realization of the processes.
The programs for education, improvement and motivation of the employees are continuosly realized, enabling full contribution in maintaining and promoting of the quality of work, which makes Replek Farm Ltd Skopje to be one of the leading Pharmaceutical companies in our country.
Responsibilities of the Quality Assurance System
- The medicinal products are designed and produced in accordance with the requirements of the Good Manufacturing Practice ( GMP ).
- The final product is correctly produced and checked, in accordance with the prescribed procedures.
- The final products are not distributed and sold without the Qualified Person has certified that each batch is produced and controlled in accordance with the European and National requirements for GMP and complies with Specification of quality on the basis of which is granted Marketing Authorization for placing the finished medicinal product on market.
- Production and control operations are clearly specified in a written form and GMP requirements are adopted.
- Managerial responsibilities are clearly specified in job descriptions.
- Arrangements are made for the manufacture, supply and use of the appropriate starting and packaging materials with conducting Audits of suppliers.
- Investigations of deviations and results out of specification
- Responsible for validation processes and validation plans.
- Arrangements are made that medicinal products are stored and distributed according GDP.
- Responsible for the documentation system for quality and environmental protection.
- Responsible for claims and complaints from the customers.
- The employees are trained to carry out their job correctly
- Accompanying external inspections and checks
- Responsible for self – inspection control and check of the accuracy of the quality system
- The environmental aspects in individual manufacturing phases are monitored and the following results are evaluated
- Following of the Regulatory laws and International standards from the area of Environmental protection and implementation of the new requirements.
Environmental management system
The Environmental Management System is included in the Quality Assurance System.
As a result of system establishment and introduction of the environmental protection standard ISO 14001:2004, the following documents are prepared and apply:
» Guide on quality and environmental protection
» Environmental protection purposes
» Environmental protection program
In this way the human activities are controlled and managed due to the reduction of the negative impact on the human environment, spending of raw materials, energy and waste management, with an aim of achievement and maintenance of ecologically efficient work that will reduce the pollution.