A BRIEF PROFILE
ARION HEALTHCARE Established in 2005, has setup an state of the art facility as per G.M.P. Standards to manufacture Tablet (Both Beta & Non Beta), Capsule (Both Beta & Non Beta), Liquid, Dry Syrup, Injection (Liquid & Dry), Ophthalmic & Ointment sections. Arion is an organization run by young and dynamic professionals in the Pharma Industry in the North Western India. Arion is a company with over 250 plus satisfied customers and an annual turnover of more than INR 250 million. Arion has grown from a 25 people company since its inception to over 300 people presently.
ARION Healthcare has been licensed by the Drug Controller Himachal Pradesh, to manufacture formulations Tablets, Capsules, Liquid, Dry Syrup, Injection, Ophthalmic and ointment section vide manufacturing License No MNB/05/212 & MB/05/213.
The company has pharmaceuticals formulation plant situated at Village â Kishanpura Teh â Nalagarh, Distt- Solan (HP). The total covered area is about 40000 sq. ft. and the facilities include Raw and Packing materials warehouses, finished Goods warehouses and sections for the manufacture of Tablets, Capsules, liquid, Dry Syrup, Injection, ophthalmic and Ointment. All dosage forms are listed in its own well equipped testing laboratory included raw materials and packing materials.
The operations of the Company are managed by experienced technical staff for production and quality control along with a team of expert technicians.
As an integrated pharmaceutical company we share collaborative & symbiotic relationships with preferred business partners, all of whom reflect our business ethics, trust & transparency and quality standards.
To help people live healthier lives. To give access to the best healthcare products at affordable Price to everyone.
To become a discovery led global pharmaceutical company
Our business practices are guided by the highest ethical standards of truth, integrity & transparency
Our esteemed customer list includes: Unichem Labs, Medley lab, Biochem India, Biostadt and Morepen Laboratories to mention a few. These customers have continuously reposed their trust in our quality and delivery.
Arion believes in delivering the best of quality to its customers and we have more than 70% repeat orders every quarter. This we owe due to our commitment to strong professional standards and fulfilling commitments every time.
Our Production Facility
Located on a 2000 sq. meters plot, having more than 40,000 sq. ft. of operations area, the Plant is solely dedicated to manufacturing of Pharma products by following the best of quality processes and skilled staff.
The production site has a centralized utilities section with Generators, Compressed air system fitted with air filter and AHU system and boiler. The water softening plant, the demineralization water plant and Multicolumn plant are located on the third floor.
The production facility is headed by a Director of the Company. The people have been organized in different teams for Production, Independent Quality Control and Quality Assurance, Warehouse Management, Personnel and Maintenance. The staff at Arion is experienced and trained in the best practices in the Pharma Industry. Today Arion can vouch that its people have been a part of continuous improvement in the processes and standards and are an asset for the Company.
This facility is having its own fully equipped laboratories with almost all the in-house testing facilities of the products being manufactured. Apart from in-house facility, assistance of reputed and competent laboratories is also taken, to ensure that the products manufactured meet or exceed the required standards and requirements.
Our core Areas
Our core businesses of Active Pharmaceutical Ingredients (API) & branded Formulations are planned to meet with growth & profitability.
Tablets Section (Both Beta & Non Beta) 15, 00,000 per Day/shift
Capsules Section (Both Beta & Non Beta) 5, 00,000 per Day/shift
Liquids Section 1, 00,000 per Day/shift
Ointment Section 50,000 per Day/shift
Dry Syrup Section 25,000 per Day/shift
Dry Injection (vial) 1, 00,000 per Day/shift
Liquid Injection (vial) 50,000 per Day/shift
Opthalmic 50,000 per Day/shift
Ampoules 1, 00,000 per Day/shift
Quality Standards and Internal Audits
A brief glimpse on our quality standards will let you know about the high standards being maintained by Arion:
â¢ W.H.O âGMP Standards.
â¢ Clearly defined Quality policy.
â¢ Independent Quality Control Department for Materials, in-process and post-production quality testing
â¢ Empowered Independent Quality Assurance Manager looks after total Quality Management function for the whole organization. Quality Management System is designed for Zero Defect Product with full responsibility of Quality Assurance Manager.
â¢ Procedures and process evaluation and validation are done by the specific department and approved by Quality Assurance Department. Only after approval of QM team is a process or procedure included in the production.
â¢ Competent Technical Staff to carry out the Manufacturing Operations and analysis.
Quality Assurance Department prepares issues and updates Quality Policies, maintains and controls all documentation related to technology transfer, attending market complaints and regulatory affairs.
There is an internal audit operation system to assess adequacy of QA system.
At Arion, Specifications and STPs are prepared by QC and finally reviewed and issued by Quality Assurance. In case of regulatory specifications and STPs, Department of Regulatory Affairs is consulted. Specifications and STPs are written in prescribed Format with identification no., effective date and approval signatures. These are updated on any change in regulatory requirements or pharmacopoeias or change in Specifications and STPs Department of Regulatory Affairs are consulted.
Self Inspection & Quality Audits
Self Inspection and Quality Audit is carried out with the objective to detect any Shortcomings in the implementation of cGMPs and recommending the necessary Corrective actions. There is a team of Quality Assurance Manager, Works Manager, Engineer and concerned department heads for self-inspection. Such inspections are carried out as per defined procedure.
The company has structured a training program which covers the entire employee. The Managers are exposed to different area any programs as per need assessed by divisional Head. This activity is co-coordinated by corporate training cell under the personnel manager.
â¢ Personnel Hygiene & Sanitation
â¢ Manufacturing Techniques
â¢ Operation of Equipment
â¢ Cleaning Procedures
â¢ cGMP Requirements
All environment parameters like particle monitoring HEPA filter integrity testing, Air Change rates, Air pressure differentials, Temperature, Humidity and Microbiological Monitoring are checked at periodic intervals.
No toxic or hazardous and sensitizing materials are handled in Arion or any of its facilities. All facilities are totally enclosed and designed for the exclusive use for manufacturing only.
Healthcare and Preventive Maintenance Program at the Premises
Each weekend the maintenance in charge along with the Quality Assurance Executive and respective departmental heads, visit each part of the factory to Locate and rectify areas which may require maintenance e.g. cracks /breakage In structures /plastering, painting etc.
The major equipments are supplied by reputed manufactures in their field. These Are manufactured as per international norms with the best materials available (GMP Models). A list of major production, Quality Control equipments and utilities with their manufactures is enclosed in Annexure.
The Q.A Department prepares issues and updates the Q.A policy. The Q.A Department is responsible for preparing, revision and distribution of all documents for manufacture. All master documents are stored in Central Record Room in Q.A Dept and documentation control as per respective SOPs. Every master document has a review period and it is reviewed mandatory on or before that date. Circulation of these documents is restricted to authorized users and to be controlled by issuing department. On changes documents are rewritten duly checked authorized and signed by two independent persons. All superceded copies of the document are destroyed except one copy, which is kept for reference purpose and is prominently marked as âSupercededâ.
The Production Planning Department issues a computerized batch production records (BPR) for manufacturing a batch. The BPR consists of a formulation order and a packaging Order. The formulation order is as per the Master Formula Issued by formulation Development Laboratory and which has been fed into the Computer. Access to update this master formula on the computer is restricted only to concerned Formulation Department Manager.
Based on the bill of materials the computer assigns particular quantities of raw materials (active &inactive) for that particular batch on FIFO basis. The dispensing of the material required for the particular batch against the particular Quality Control Analytical Reference number mentioned in the Formulation Order is done by a technician in presence of a warehouse supervisor.
The batch is then fabricated /manufactured as per the manufacturing instructions Given in the BMR. Every operation requires a âdoerâ and âcheckerâ signature in â Process checks are carried out at predetermined time intervals by both, production and in â process Quality Assurance Executives and recorded in the BMR.
Samples of intermediates and finished goods are taken and are checked by Quality Control Laboratory. In case the batch meets the specifications, the Quality Assurance Manager reviews the complete batch manufacturing record to ensure compliance with cGMPs during the manufacturing. The batch is then released for distribution by the Quality Assurance Manager.
Quality Control Department is part of the Quality Assurance Department. It is headed by a Quality Control Manager. The major activities of the Quality Control Department are.
1. Approve/Rejection of raw and packaging materials as per respective SOP.
2. Testing of in- process samples as per respective SOP.
3. Testing of finished goods as per respective SOP.
4. Carrying out stability studies as per respective SOP.
5. Testing of water as per respective Sop.
The batch Production Record is then reviewed by the Quality Assurance Manager He checks that all the documents are complete in all respects and for e compliance with cGMPs various steps. The Q.A Manager âReleasesâ the batch for distribution by signing the BPR.
In case of product recall the Q.A Manager informs the Head of Marketing through telephone, telex or fax informing him about the recall this is followed by a written communication by the QAM to the Head of Marketing. The Head of Marketing then informs through telephone, telex or fax followed by a written communication to all Division /Regional Managers to quarantine stocks and withdraw the batch from the wholesalers /retailers.
The company has a defined Self Inspection System through which all manufacturing functions, Engineering Department, Quality Control Department and warehouse are audited by a team of managers consisting of Works Manager, Q.A Manager and Production Manager and the Department Head of Department being audited. The audit is carried out as per the SOP. All deficiencies noted in the inspection are attended to by the Departmental Head and report is issued by him.
Contact us at:
SCO 907, IInd floor, N.A.C. MANIMAJRA, Chandigarh
Phone no. : 0172-5076001, 5076002
contact person : Abhay Jain (09216627222)
Ravi Jain (09216626222) ARION HEALTHCARE
Vill- Kishanpura Teh âNalagarh
Distt âSolan (HP) - 174 101
Phone no. : 01795236299,01795236520
Fax no. : 01795236311
S.C.O 907, Manimajra, Chandigarh