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To ensure success in the global marketplace, Herbion pursues quality with a single minded determination. It keeps a check on the quality throughout its production cycle: from raw materials to finished products. It also ensures that the quality of drugs manufactured are in compliance with the local regulatory & cGMP requirements and not placing patients at risk due to inadequate safety, quality or efficacy studies.

To achieve the quality objective reliably, Herbion has designed and comprehensively implemented an independent Quality Operations Department. It is supervised by qualified staff and is provided with all the essential equipment and facilities. The findings from the department are documented completely. The effectiveness of the system is constantly monitored and assessed.

Herbion quality operations system is divided into two sections:

1 Quality Assurance
2 Quality Control

Quality Assurance

Herbion Quality Assurance ensures:

  • The drugs are designed and developed in compliance with the cGMP and local regulatory requirements.
  • Each and every step of the production procedure is clearly specified in a written form and cGMP requirements are adopted and followed.
  • All necessary controls on raw materials, intermediate products, bulk products and finished products and all other in-process checks are carried out. Throughout the manufacturing process, in-process control is carried out at regular intervals to ensure the quality of the finished product.
  • All necessary calibrations and validations are carried out before placing the product in the market. Validation studies are conducted for important equipments and machines, methods of manufacturing, quality control and cleaning procedures in accordance with predefined protocols.
  • Finished products are not supplied or sold before authorized personnel have certified that each production batch has been produced and controlled in accordance with the requirements of cGMP and conform to the required specifications and standards.
  • The effectiveness of the Quality Operations System is checked at appropriate intervals through self inspections and audits.
  • All products which are sold in the market are monitored through a comprehensive Post Marketing Surveillance System. In case of any complaints from the market, proper investigation is carried out to discover the root cause of the complaint. Appropriate preventive and corrective measures are taken promptly in order to prevent recurrence.

Quality Control

The Quality Control department has adequate facilities and approved procedures for sampling, inspection and testing raw materials, packaging materials, intermediate products, bulk products and finished products.

  • All necessary equipments like High Performance Liquid Chromatography (HPLC), Ultra Violet Spectrophotometer (UV) etc., are available for the test and analysis of drugs. The protocols for the test and analysis of the drugs including their validation, where applicable, are also available.
  • A separate Microbiological Laboratory is available which is well equipped with facilities for Microbiological assays, sterility testing, raw material and finished products testing, endotoxin testing and environment control.
  • The stability testing of new products is carried out and product's shelf life is determined before placing the product in the market. Products already marketed are also tested for their stability as per predefined procedures.
  • Environmental monitoring of non-sterile areas is carried out regularly to ensure proper ambience.
  • All waste generated throughout the processes are disposed through Waste Management System to keep the environment pollution free.

 


 



 

 







 

 
   
   
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  Herbion Pakistan (Pvt) Limited
Tel: (92-21) 111-503-111
Fax: (92-21) 5044263
E-mail: info.pk@herbion.com