Pharmtechnology LLC
Quality System
The purpose of our Company’s quality policy is to assure quality, safety and effectiveness of manufactured pharmaceutical products.
Quality Assurance Measures:
• The company receives starting and packaging materials from approved manufacturers and suppliers and these materials are tested on a mandatory basis in accordance with the approved methods
• The starting and packaging materials can be used in the production process only subject to release by the quality control department
• Production of each product batch is documented in the batch records/ packaging protocol and a Batch Manufacturing Record is created
• Respective quality control records are kept
• Continuous verification is performed to confirm the reproducibility of existing process results;
• Control of intermediates, finished products and production process is performed and the processes are validated
• Quality audits are performed to evaluate the effectiveness and compliance of the quality assurance system
• Each product batch is sold only after being evaluated and released by the Qualified Person, upon receipt of the confirmation that the batch was manufactured and controlled in accordance with the requirements of Good Manufacturing Practice
The fundamental tools to ensure functioning and improvement of the pharmaceutical quality system include:
• Management Review
• Change Management System
• Complaint Management System
• Quality Risk Management (QRM)
• Non-Conformance Management System
• Corrective and Preventive Actions (CAPA)
• Ongoing Personnel Training
• Document Management System
Strategic Goal in the area of PQS:
• ongoing improvement of the quality system ensuring continuous production of safe, effective and high-quality medicines.
• the concepts of quality and safety must become a tag line for companies of pharmaceutical industry. Successful distribution of pharmaceutical products in conditions of market economy depends to a major extent on customers’ and buyers’ confidence in the manufacturing companies.
We endeavor to manufacture medicinal products in such a way as to assure their fitness for the intended purpose, compliance with the requirements of the registration dossier and/or clinical trial protocols and minimize the risk for patients in terms of safety, quality and effectiveness of medicinal products. Our company adheres to the following paradigm: the product quality is the right of a patient and the obligation of every employee of Pharmtechnology LLC.
Our company has a developed, implemented and correctly functioning pharmaceutical quality system. The quality responsibilities are distributed inside the company, among all divisions and employees who are in charge of the production process.
The quality system covers the whole product life cycle, starting from the development stage, the subsequent production stages, sales to the final consumers and discontinuation of the medicinal product. One of the top priorities of the company is to ensure guaranteed stable quality of all medicinal products.
References:
Technical Code of Common Practice ТКП 030-2017 (33050) Good Manufacturing Practice; Decision of the Council of the Eurasian Economic Commission dated November 03, 2016 no. 77 “On Approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union”; EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, vol.4 ICH Quality Guidelines ; WHO Good Manufacturing Practices Guidelines PIC/S Good Manufacturing Practices Guidelines