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Group Pharmaceuticals Limited is a closely held unlisted Company. The Company was incorporated on June 1st 1980 as a Private Limited Company and subsequently the company changed its status to Public Limited Company on 21st April 1993. The Registered office of the Company is situated at : W/46 (B) MIDC, Tarapur and Administrative office at Devraj Building ‘A’ wing, III Floor, S.V. Road, Goregaon west, Mumbai – 62.
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In view of expansion of the business, Group Pharmaceuticals Limited has incorporated a new plant with all advanced technologies and sophisticated equipments, complying with WHO, cGMP and Schedule M, at KIADB Industrial area, Malur, Kolar District. The plant is located around 53 Kms from Bangalore city and 20 Kms from Hoskote, on the road that is connecting Old Madras Road and New Madras Road. The nearest Railway station is at Malur, which is only 1.5 Km away from the plant. |
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| Quality is evident as soon as you enter our premises, from the well-manicured lawns and the lush green surroundings. Quality is reflected in the plan and design of the plant, with a uni-directional flow of material and required Quality of air . The Quality of our people is evident from their expertise in pharma-manufacturing. Quality beyond compromise, Quality, assured by constant monitoring and analysis at every stage. |
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| Address: |
| Group Pharmaceuticals Limited, |
No. 41, KIADB Industrial Area,
Malur – Kolar Dist – 563 130,
Karnataka |
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| Group Pharmaceuticals Limited is surrounded by : |
| Garment industry, Pharmaceutical industry and Petrochemical industry. |
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| Group Pharmaceuticals Limited already has two well established factories : |
- Group Pharmaceuticals Limited, Tarapur
- Suyog Pharmaceuticals, Tarapur
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| Group Pharmaceuticals Limited has complimentary production facilities, good marketing network and foreign collaborations too. The company has geared up to march ahead in facilitating its consumers with all the latest developments that has taken place in the pharma market with Dental and Oral care products in particular. |
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| Pharmaceutical manufacturing activities as licensed by competent authorities : |
| As far as the statutory requirements are concerned, Group Pharmaceuticals Limited has completely fulfilled the obligatory documentations, clearances, certificates, registrations as per the current rules and act in the enforcement. Company has good, qualified and experienced personnel to look after these matters. |
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| Group Pharmaceuticals Limited are permitted to manufacture pharmaceutical dosage forms from Drug Control Department, Govt. of Karnataka, Bangalore, India under Licence No. KTK/25/475/2001. |
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| Other manufacturing activities carried out on site : |
| Group Pharmaceuticals Limited do not have any other manufacturing activities in the above said premises. Group Pharmaceuticals Limited is completely dedicated for Pharma manufacturing and marketing business. |
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| Name and exact address of the site, including Telephone, Fax and 24 Hrs Telephone numbers: |
| Location : |
| Present factory with all GMP facilities is situated at : |
| Group Pharmaceuticals Limited |
41, KIADB, Industrial Area,
Malur, Kolar Dist – 563 130, Karnataka.
24 hours Telephone : 08151 - 334237, 08151 - 335220 |
Fax : 08151 - 335084
Email : groupmalur@vsnl.net |
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| Type of actual products manufactured on the site and information about specifically toxic or hazardous substances handled : |
| Non-sterile products are manufactured in the premises. Types of products manufactured are liquid dosage form and semi-solid dosage forms. |
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| Toxic and hazardous substances are not handled in the premises. Group Pharmaceuticals Limited manufactures products for human use only and veterinary products are not produced. |
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| Liquid dosage forms includes Mouthwashes, Liquid Oral Suspension & Syrups. Semi-solid dosage forms includes Astringents, Medicated Gels, Creams & Ointments. |
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| Short Description of the site : |
| Group Pharmaceuticals Limited is located in KIADB industrial area. The total area of the land is 4 Acres. The built up area is 35,000 Sq. ft. The plant enjoys very good atmosphere and is surrounded by lush greenery. Group Pharmaceuticals Limited is having its own effluent treatment system, and there is no paucity of water supply. The industrial area has got good Electrical Transmission system with a power of 260 KVA. The unit has an internal generation arrangement of power supply through 250 KVA Diesel Generator set to ensure uninterrupted power supply in case of a power cut .The unit was constructed in 2001 and started its operation from March – 2002. |
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| Plot plan – Annexure I - Enclosed. |
| Number of Employees engaged in Production, Quality Control, Storage, Distribution, Administration, Maintenance, Security and Housekeeping: |
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| Group Pharmaceuticals Limited has employed efficient personnel workers to its satisfaction level through better way of selection through it own criteria. |
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| The numbers of employees are as follows : |
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| With the support of the above-mentioned staff, Group Pharmaceuticals Limited is manufacturing products of their own as well as for Dr. Reddy’s Laboratory on third party basis & Loan Licence. |
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| Use of outside Scientific, Analytical or other Technical Assistance in relation to Manufacture and Analysis : |
| Apart from regular analysis and calibration done at our own analytical laboratory, help is taken from outside Laboratory and calibration services. |
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| Instrument Installation and Maintenance Engineers – IIME |
| Calibration Services of Electrical, Mechanical and Control instruments |
Kyaswar Mansion
180/44, 16th Main,
4th T Block, Jayanagar,
BANGALORE – 560 041
Tel. : 080 – 6530093, Telefax :080-6654488,
Mobile :98450 46294. |
| For validation and calibration of incubators, refrigerators and all digital display instruments. |
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| Banglore Test House |
Mr. Vargis
No. 65, 20th Main,
Marenhalli, Vijayanagar
BANGALORE – 560 040
Tele : 080 3388895 , Fax : 080 3385979 |
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| For impurities and assay of Raw materials as well as finished products using instruments like HPLC, GC and IR. |
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| Apart from chemical and microbiological analysis of pharmaceutical products, they also undertake Effluent, treated water, Air polluted Environmental samples like sand, mineral water, food, pesticide, cosmetics, etc. |
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| Shiva Analyticals, Hoskote & Ashco Analytical Services Hyderabad are also helping us in analytical section. Apart from pharmaceutical analysis they are also analyzing water and food samples. |
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| Address |
Shiva Analyticals (India) Ltd.
Plot No. 24D (P) and 34D,
KIADB Industrial Area,
Hoskote – 562 114
Tele : 080 – 5353961
Website : www.shivalabs.com |
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| Ashco Analytical Services, |
103, Diamond House, 6-3-83/D3/D4
Behind TOPAZ, Panjagutta,
HYDERABAD – 500 082
Ph. No. 040 – 3406557. |
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| Quality Management System : |
| Group Pharmaceuticals Limited, has its own Quality Management system. It includes management, QA and QC and other related wings. |
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| Quality policy of the Company : |
| “To provide consistently High Quality Products in the field of Health care to the satisfaction of medical profession and the consumers. This is being achieved by cumulative efforts from the top management to the lowest cadre of the workmen by maintaining preset working standards aimed at Defect prevention rather than Defect Detection”. |
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| Responsibility of Quality Assurance: |
| Quality Assurance Department functions independently to attain the specified standards. Production and Control operations are clearly specified in written procedures to meet the requirements of cGMP. The responsibility of QA are Line clearances, Batch Record Review, In-process checks, investigation of deviations, self inspection, Trainings, Handling of market complaints, preparation of documents and their distribution to various departments etc. |
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| Elements of QA : |
| Managing Director – Asst. QA officer — Jr. QA Officer. |
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| There are written specifications for all incoming materials like Raw materials, packing materials and finished product. Pharmacopoeias such as IP, BP, and USP, NF are taken as standards for Raw materials, and for all packing materials standard. In house specifications and test methods are available. |
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| All bulk intermediate and finished products are tested to In house standards as well as pharmacopoeial standards. |
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| There are written down procedures to test all the input materials and finished products. Apart from this, written down procedures are there for validations of all equipments, instruments, premises and service areas. |
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| There are written down procedures and standards for checking the effectiveness of cleaning equipments, pipelines etc., at the time of change over of products. Stability studies are carried out as per ICH guide lines, based on the data, shelf life of the products are reviewed from time to time. |
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| Audit Programmes: |
| Self-inspection is done periodically by QA to ensure that all systems are in place. Then after evaluation, reports are made and brought to the notice of audited departments to understand the system better and to take corrective action plan wherever necessary. |
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| Review of quality system: |
| Compliance auditing is performed to confirm the completion of discrepancies observed. |
| The plant is externally audited by relevant authorities / agencies for cGMP and Schedule M compliance. The results of audits are reviewed and compliance audits are conducted to ensure quality efficacy and safety of the product. |
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| Vendor validation: |
| To maintain uniform quality of the products manufactured at Group Pharmaceuticals Limited, materials are purchased from the same suppliers and manufacturers, who have been supplying to Tarapur unit all these years. |
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| However when a new vendor is to be approved, Group Pharmaceuticals Limited has written down procedures for approval of new vendors. Stability study of the product is done when there is a change in manufacturer of critical materials like active ingredients, excipients, Primary Packing materials & any critical equipments. |
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| Requirements for dispatch release of finished products: |
| All finished products are tested to the specified standards as given in specification. The products are subjected to chemical and microbiological analysis for total counts of microbes and absence of pathogenic organisms. The products are released for dispatch after compliance of the products to the specified standards. |
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