Quality Control

We are aware of the values to be gained by producing quality products...
As Alpler Medikal, we wholeheartedly support the ever-increasing understanding of quality.

Our primary quality policy is to produce products and services that provide high added value, confidence and customer satisfaction.

It is one of the leading quality policies of our company to make production flawless and to respond to user needs completely. We continuously monitor all quality and control targets from the first stage to the last stage of our trade with all the companies we sell products to in many countries of the world. As Alpler Medikal, we offer the most suitable products and services in line with the needs of the user and the sector.

In line with our vision in the sector, we produce easily accessible and reliable products by using developing and up-to-date technologies. In this context, keeping customer satisfaction at the highest level and managing customer feedback effectively in the products and services we provide constitute the basis of our quality policy.

Based on quality norms, we always carry forward our quality standards mentioned in the company structure in a team spirit. In line with the continuous improvement approach, we fulfill all the necessary conditions to increase the efficiency of all our production processes to the highest level in Turkiye and abroad.

It is always our priority to be a pioneer in scientific research by using modern technology with our professional team and to work without compromising ethical principles. We pay attention to act in accordance with world standards, international legal regulations, national laws and regulations.

With a proactive quality management, we increase our efforts day by day to measure the satisfaction of the end user by constantly auditing our products.

CERTIFICATES

• ISO 13485:2016 INTERNATIONAL MEDICAL DEVICES QUALITY MANAGEMENT STANDARD
• EC DECLARATION OF CONFORMITY
• FDA CERTIFICATE
• TSE SERVICE COMPETENCE CERTIFICATE
• MEDICAL DEVICE SALES CENTER AUTHORIZATION CERTIFICATE
• LOCAL MANUFACTURE CERTIFICATE

TRADEMARK REGISTRATION CERTIFICATES

• ALPLER MEDİKAL TRADEMARK REGISTRATION CERTIFICATE
• STERVAC TRADEMARK REGISTRATION CERTIFICATE
• STERPANEL TRADEMARK REGISTRATION CERTIFICATE
• STERPORE TRADEMARK REGISTRATION CERTIFICATE
• STERPAD TRADEMARK REGISTRATION CERTIFICATE
• ESTERILE TRADEMARK REGISTRATION CERTIFICATE

Quality in STERVAC Branded Health Products Production
Healthcare products must be of the highest quality as they directly affect human health. Quality healthcare products ensure that patients receive safe and effective treatment and protect public health.

Elements of Quality in the Production of STERVAC Aspiration Systems Products:

• Good Manufacturing Practices (GMP): GMP (Good Manufacturing Practices) is a set of principles and practices that ensure safety, efficiency and quality at every stage of the manufacturing process of healthcare products.
• Quality Control: It is a set of tests and analyzes that ensure that quality standards are met at all production stages from raw materials to finished products.
• Quality Assurance (QA): QA is a set of activities that ensures that the entire production system produces and maintains quality products.
• Personnel: The personnel working in production must be trained, experienced and competent.
• Equipment: The equipment used in production must be of good quality, up-to-date and well maintained.
• Facility: The production facility must be designed, constructed and operated in accordance with GMP

Quality Control Methods:

• Physical and chemical analysis: Testing the physical and chemical properties of raw materials and finished products
• Microbiological analyzes: To check the sterility and microbiological safety of products
• Biological analyzes: To test the biological activity and efficacy of products
• Clinical research: Investigating the safety and efficacy of products in humans

The Importance of Quality Health Products:

• Patient safety: Quality products ensure that patients receive safe and effective treatment.
• Public health: Quality products protect public health and help prevent diseases.
• Economic benefit: Quality products reduce costs in manufacturing and health care.
• Company reputation: Quality products enhance a company's reputation and competitiveness.

Producing quality healthcare products is a complex and multifaceted process. To succeed, the following key steps need to be followed carefully:

1. Quality of Raw Materials:

• It is critical that all raw materials used in production are obtained from high quality and reliable sources.
• Raw materials must be rigorously checked for compliance with all relevant pharmacopoeias and regulations.
• Quality control laboratories should perform the analysis and release of raw materials.
  
  2. Production Process:
• The production process must be designed and implemented in accordance with the principles of Good Manufacturing Practices (GMP) and relevant regulations.
• Production stages should be documented in detail and quality control tests should be performed at each stage.
• Production equipment and facilities should be regularly calibrated and maintained.
  
  3. Quality Control and Quality Assurance:
• Throughout production, a comprehensive quality control and quality assurance system must be in place to ensure the quality and safety of products.
• This system should cover all stages of production, from the acceptance of raw materials to the release of the final product.
• Quality control laboratories should have the necessary equipment and specialized personnel to perform the necessary tests and analyses.
  
  4. Staff Training:
  All personnel involved in production must receive comprehensive training in GMP principles and related procedures.

Personnel should be made aware of hygiene, safety and quality control issues and should follow up-to-date information through continuous training.

5. Continuous Improvement:
A continuous improvement and development-oriented approach should be adopted to produce quality health products.

New technologies should be followed, production processes and quality control systems should be continuously reviewed and improved.

Additional Recommendations:

• It is important that the production facility is in a hygienic and safe environment.
• Products must be stored and transported under appropriate conditions.
• Products must comply with all legal requirements and standards.
• Users should be provided with accurate and complete information about the products .

Producing quality healthcare products is a responsibility that directly affects human life. Therefore, a rigorous approach must be adopted in all production processes and the highest quality standards must be observed.

Note: The above information provides a general framework. Depending on the product type and production process, there may be special requirements. For more detailed information, it is recommended to consult the relevant regulations and experts.