Astamed Healthcare (I) Private Limited

Astamed Healthcare (I) Pvt. Ltd. (AHPL) incorporated in year 2002, was set up in Mumbai, the financial and commercial capital of India engaging itself into the business of manufacturing and marketing of health products, nutraceutical and pharmaceuticals products. AHPL is a professionally managed fast growing ISO:9001:2000 certified private limited company having GMP certified & WHO compliant manufacturing facility. AHPL is committed to doing business in an efficient, responsible, honest and ethical manner. Good corporate governances goes beyond compliance and involves a company wide commitment. This commitment starts with the board of directors, which executes its corporate governance responsibilities by focusing on the company’s strategic and operational excellence and on the best interest of all our stakeholder, in particular employees and our customer in a balances fashion with long term benefit to all.

The core values of the Company’s process include independence, integrity, accountability, responsibility & Fairness. The Business policies are based on aspects like ethical conduct, health, safety & commitment to building long-term sustainable relationship. AHPL is committed to continually evolving & adopting appropriate corporate governance best practice.

Mr. NAYAN THAKKAR, has completed his studies in Pharmacy from reputed institute – Bhartiya Vidyapeeth – Belapur (Navi Mumbai) in 1991. He is the founder promoter and has led the company since its inception in 2002, completed his studies in Pharmacy he was more eager to know the laws to be followed by the each manufacturing company, the strategy adopted by the company for launching the products and the sale strategy to run the product efficiently in the market. With a clear vision to gain a landmark success in this industry he stepped ahead and started his mission to reach his goal.

Mr. HEMANT SETHIA, has completed his studies in commerce stream. He is a first generation entrepreneur with more than 25-year experience in the pharma distribution. With this deep-rooted distribution network he acts as a backbone to the brands of the company.

The construction, facilities and machineries are as per the WHO GMP standards. The manufacturing area is designed as per Clean Room specification. All primary manufacturing areas are designed as per Class 10,000. All the machinery in the factory is designed to meet the GMP requirements. Light is installed with necessary lux being maintained at all times. AHU’s is also made separate for each area and of appropriate capacities prescribed by the authorities.

The service & maintenance floor is so designed that the maintenance staff can do their regular maintenance without entering the manufacturing area thus keeping all the contaminations away from the manufacturing area and carrying on the manufacturing and maintenance activities without interrupting each-others activities. Adaptations of latest technology and atomization have been considered as one of the key factor in designing each and every department having manufacturing and filling activities to achieve GMP requirements.

Products: We manufacturer and export various health products, nutritional & pharmaceutical formulations such as pharmaceutical medicines, pharmaceutical capsules and pharmaceutical tablets, powder nutritional, liquid oral, powder oral, pellet drugs and lotion.

Market Complaint:
We are categorizing our complaints as minor, major and critical and investigated in detail. After receiving complaint we make primary investigation report within 36 hours and giving detailed report after 72 hours.

OOS/Deviation/Incident reporting system/Change control:
Above systems are very effective and closely controlled by General manager QA. every deviation, incident and change control is investigated with all possibilities and then it is getting approved.

Quality Communication:
Regarding any query about quality system .We are responding very fast and have better means of communication. Our first preference will be Quality communication.

Esteemed Clients:

• M/S. Merck Ltd.
• M/S. Shalina Laboratories Pvt. Ltd.
• M/S. Elder Pharmaceuticals
• M/S. Cibanova Healthcare Pvt. Ltd.
• M/S. Karnataka Antibiotics & Pharmaceuticals Ltd.(A Government Of India Enterprise)

Quality Policy & Approach:
The quality system is designed and operated so as to ensure that every unit that is manufactured by us shall adhere to the prescribed standards and requirements for the product. We shall strive to build customer confidence through value, technology and reliability. Quality objectives shall be set across the whole organization, which shall be pursued, measured and reviewed periodically. We are working as per all GMP norms and regulation with highest positive attitude towards quality.
Master Validation Plan:
It includes description of the validation program including roles and responsibilities.

• Identification and location of the facilities, systems, equipment and process/products to be qualified or validated
• References to the procedures and guidelines to be used
• Maintenance and calibration programs
• Training programs
• Change control procedures
• Documentation requirements
• Schedule of activities

Calibration and preventive maintenance:
We believe that Good machine can deliver good quality, Organization is following the schedules calibration and preventive maintenance schedule for every equipment.

Documentation Control:
Established and maintained documented procedures (including approval, issue and changes of documents and data) to control all necessary documents related to Manufacturing and Quality Assurance.

All procedures and necessary documents relating to and in connection with the quality system of the location shall be uniquely identified by means of document name, code & date (where applicable). In case of controlled procedures, it is responsibility of the departmental heads to implement it effectively & maintained. It is responsibility of QA to ensure that documentation relating to quality system is distributed in accordance with the document control procedures.

Customer imposed standards shall also be included under the requirements of controls.

Self Inspection Program:
Self Inspection on all systems, procedure and operations shall be conducted regularly in order to monitor compliance with and the effectiveness of cGMP and Quality Assurance principles in the various operations and to allow for improvement and corrective measures here required.

Training:
Training is considered as one of the most necessary and effective tool for development and growth of individual and organization as a whole. Training is a continues process and the management and departmental head are, by request or observation identifying and initiating the ongoing training requirements of employees, to maintain and develop the quality and efficiency of operations.

 The in-house training programme consist of:

•  Induction programme
•  CGMP requirements
•  Safety Training on use of equipment (on-the job training)