OUR EXPERTISE

Protech Telelinks produces more than 1000 pharmaceutical formulations in its ultra-modern WHO GMP manufacturing facilities located at Yamuna Nagar in Haryana and Kala Amb in Himachal Pradesh. Both units are fully licensed to produce a range of pharmaceutical products under the Indian Drugs & Cosmetics Act, 1940. Each unit manufactures a specific range of products and each product group is allocated a specific area within the overall facility. Manufacturing activities take place in a modern RCC building with PU paint inside and epoxy flooring, suitable stainless sanitary drains, modern ventilation system to prevent contamination while assuring high levels of comfort and an RO water purification plant using in-premises water bore.

Manufacturing sections are equipped with machinery like sterilizers, ampoule and vial sterilizing and washing equipments, filling and sealing equipments, blister packing equipments and a separate quality control unit with appropriate set of equipments to test raw materials, processes and finished products.

Each unit has well defined areas for production of various category of products, warehouses for raw materials and finished goods and a separate section for office in addition to provision for ancillaries like water purification and waste water treatment. An engineering department is in charge of maintenance of equipments and a special crew takes care of daily cleaning and sanitation processes to assure highest levels of hygiene.

Quality

Quality is at the core of success of MAK and its range of trusted pharmaceutical formulations. Here at Mak we are fanatically committed to world class quality standards and implement CGMP processes for our products to comply with FDA, EU and JP standards. We use in-house quality control and quality assurance processes in addition to third party quality certifications to guarantee absolute reliability.

Our unit has an independent quality control laboratory, utilizing about 26 people, spread over an area of 1800 square feet located on the first floor of the production building. The lab tests raw materials, packing materials and in process samples in addition to finished products. Complete testing and analysis of raw materials is carried out in-house. If our test equipments and processes cannot test for a specific process or a specific ingredient, we get testing done by third parties.

Quality management system controls QC equipments and processes. A well defined QMS covers quality assurance, quality control, good manufacturing practices, sanitation and hygiene. The management processes additionally incorporate complaints, validation, product recall, self-inspection, audits and processes for raw material checks, in-process checks, finished product check and checks of culture media and reagents.

Quality Assurance and Analytical Research & Development department under the Manager QA & QC handles all functions and reports to the General Manager and Plant Manager. It is responsible for preparing and updating quality policy, quality guidelines, issuance of raw materials, packing materials and finished products. The department is also responsible for approval of vendors and raw materials. It maintains documentation and develops analytical test methods and validation methods on an ongoing basis besides monitoring key quality indicators. The department has diverse other functions that virtually oversee all aspects of production in addition to assuring cGMP compliance and training to employees.

Changes or deviations are fully documented and subject to procedures.

Team

Protech Telelinks owes its success to its teams of experienced, qualified and expert professionals. Each one works with dedication regardless of his designation and is fully committed to safeguarding quality of products and reputation of the company even while we serve customers with courtesy. Our team includes the entire gamut ranging from top level MBAs, Cas, HR Personnel and back office staff to pharmacists and engineers.

Each one knows his role. What makes our teams special is the way each team member interacts with the other in a collaborative environment that results in smooth workflows and enhancements in our productivity as well as product quality through constant feedbacks.

Discipline is indispensable in a pharmaceutical unit and we can proudly claim that each one is disciplined and is fully aware of the importance of following prescribed procedures that will contribute to perfect products and enhanced reputation. We cherish our people and reward them.