QUALITY

OVERVIEW

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KONTAM ‘s quality system functions as a filter on every level to ensure our products are of excellent quality and exceed the requirements and specifications of our customers and their governments.

We at KONTAM believe in the purpose of our quality policies and procedures:

  • to produce medications of superior efficacy and safety;
  • to provide assurance to the physician, pharmacist and the consumer that our products perform uniformly and for their intended purpose.
    KONTAM’s quality policy is defined as follows:

The primary task of our quality system is to function as a filter on all levels to ensure our products are of good quality and fulfill the individual requirements and specifications of our customers. This is achieved through an integrated comprehension and strict adherence to procedures, a continual focus on the improvement of internal and external systems, and constant attention to detail.

We understand that “Quality” is a combination of refined processes and procedures implemented by a highly competent staff. All employees of KONTAM, having completed an extensive training program, are specialists in their respective fields. Our efficient QA system enables us to maintain a consistent level of quality as well as sufficient internal systems and procedures, all with the same purpose – to prevent any kind of quality problems. KONTAM’s QC team ensures that every batch is released only after the necessary controls have been carried out.

QUALITY MANAGEMENT
KONTAM‘s quality management system includes all aspects of quality relating to facilities, products, and service. However, quality management is not only focused on product and service quality, but also the means to achieve it.Quality management therefore uses quality assurance and control of processes as well as products to achieve the most consistent quality possible.

The KONTAM philosophy on quality management focuses on establishing quality, productivity, and a competitive position. Our management are evaluated monthly on the following principals:

  • Customer Focus
    Understanding current and future customer needs is paramount to our success. It is our policy to meet customer requirements and exceed the expectations of all customers.
  • Leadership
    Our management establishes a system of accountability in which every employee assumes a leadership role, resulting in every member of every department becoming fully involved in achieving quality objectives.
  • Process Approach
    Every task, activity, and resource must follow established procedures to ensure uniformity and accountability in everything we do.
  • Continual Improvement
    One of our permanent quality objectives is the continual improvement of overall performance, which is implemented and evaluated on an individual level. Every employee is expected to also contribute to the improvement of the company as a whole.
  • Factual Decision making Processes
    All decisions made by management are based on data analysis and information. Decisions to be made without such required information must get approval of our Board.quality-management-system

QUALITY ASSURANCE
Quality assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of a product. KONTAMs quality system is divided into 4 areas which are constantly micromanaged: Production, Distribution, Inspections, and Quality Control. Each area has unique processes and procedures to ensure product consistency.

  • Production
    Good Manufacturing Practice (GMP) is the part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use and as required by governments. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false imagelabeling. Above all, KONTAM is most concerned with protecting the end user and avoiding risk due to inadequate safety, quality or efficacy.

 

  • Distribution
    Any comprehensive system of quality assurance must be founded on a reliable system of controlling the quality, safety and efficacy of a finished product delivered to a market. KONTAM‘s record speaks for itself – no patient adverse effects reported due to poor product quality. All of our manufacturing operations are designed to exceed the accepted norms of GMP. Our customer’s distribution channels and supply chains follow quality assurance as well in order to ensure our end users are getting quality medicines.

 

  • Inspections
    Inspections are part of the overall drug quality assurance system. The objective of inspecting pharmaceutical manufacturing facilities is either to enforce Good Manufacturing Practice (GMP) compliance or to provide authorization for the manufacture and importation of specific pharmaceutical products by foreign health ministries and drug administrations. KONTAM. frequently conducts both internal and third-party inspections to monitor the quality of both manufacturing facilities and pharmaceutical products in distribution channels, from the point of manufacture to delivery to the recipient, as a means of eliminating the hazard posed by the infiltration of counterfeit drugs.

 

  • Quality Control
    The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product. KONTAM‘s procedures range from the performance of simple chemical experiments which determine the identity and screening for the presence of particular pharmaceutical substance (thin layer chromatography, infrared spectroscopy, etc.), to more complicated requirements of pharmacopoeial monographs. Activities extend to the area of quality control laboratories (good laboratory management practices, models, etc.) for Certificate of Analysis and lists of laboratory equipment, and an external assessment scheme.quality

QUALITY CONTROL
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By definition, “quality control” means a process by which entities review the quality of all factors involved in production. For any entity involved in the production of pharmaceuticals and heathcare products, it encompasses a detailed system of inspection and control covering the production, evaluation, and distribution of every product bearing the KONTAM label or those of our clients. KONTAM‘s approach to quality control emphasizes three aspects:

  • Elements such as controls, job management, defined and well managed processes, performance and integrity criteria,
    and the identification of records.

 

  • Competence such as knowledge, skills, experience, and qualifications.

 

  • Soft elements such as personnel integrity, confidence, company culture, motivation, teamwork, and quality working relationships.

 

KONTAM‘s quality control system emphasizes the rigorous testing of products to uncover defects, and reporting to management who make the decision to allow or deny the release, whereas quality assurance attempts to improve and stabilize production, and associated processes, to avoid issues that lead to defects. As quality control issues are among the top reasons for not renewing contracts in the pharmaceutical industry, KONTAM is proud to say we have never lost a customer due to quality issues.

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