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HOE maintains a high standard of Good Manufacturing Practice.

HOE maintains a high standard of Good Manufacturing Practice.

Our manufacturing facility in Port Klang is inspected regularly by the Drug Control Authority of the Malaysian Ministry of Health. It has also been inspected and approved by the health ministry in each of the countries that currently we export our products to. In 2001 we were honoured with a visit by officers of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme, jointly known as PIC/S.

In 2010, our manufacturing facility was certified by the Australian Therapeutic Goods Administration (TGA).

Our 9000 sq m complex consists of a production floor, laboratory, engineering department, warehouse and administrative office.

The production floor consists of clean rooms with Class C standard for the dispensing and manufacture and filling of dermatological products. HEPA-filtered air is maintained at positive pressure relative to the packaging area to maintain air quality within the production floor. In line with international standards, preparations containing corticosteroids are manufactured in a separate facility with its own air-handling unit.

Production equipment includes four state of the art Fryma DisHo jacketed vacuum vessels for dermatological products. The complex manufacturing processes of heating, cooling, pumping, mixing and homogenizing are software-controlled within the stainless steel vessels to ensure elegant, homogenous creams and ointments. The cleaning process that follows is automated to maintain a good manufacturing environment.

The dispensing area is integrated into the production floor and work is carried out in laminar flow booths.

HOE Pharmaceuticals has a strong commitment to continued achievement of quality standards. The quality assurance department is independent of the production department and the QA manager reports directly to the CEO of the company.

Quality Assurance Department is divided into four sections – quality control, quality assurance, validation & research and development and well-equipped with 7 HPLC systems, GC, UV-Vis spectrophotometer, FTIR and other relevant equipment.
Physical, chemical & microbiological tests are performed on raw materials, packaging materials, bulk and finished products. Regular testing is also performed on the environment, water supply and samples from post-marketing surveillance.

Research and Development activities are dedicated to research and development of niche dermatological products. Validation is an on-going exercise to establish the integrity and correctness of all quality control and manufacturing processes.

The Engineering Department maintains and services production equipment and supervises the regular servicing by specialist-contractors of major plant equipment like the Deionised Water Plant, the steam and compressed air generators and the Air Handling Units. Critical equipment and instruments are regularly calibrated. Pest control and waste water treatment are regularly audited.

All members of the Production, QA, Engineering and Warehouse staff are on regular GMP training. They are also subjected to regular medical checks. All procedures are documented according to written instructions (SOP's) e.g. deviations, changes, complaints, product recalls, audits etc. Suppliers and contract laboratories are qualified.

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