Quality is of paramount importance in AGP operations. We ensure the quality of drugs manufactured by AGP are in compliance with local regulatory and cGMP/cGLP requirements and do not place patients at risk due to inadequate safety, quality or efficacy. To achieve the quality objective reliably, we have designed and comprehensively implemented an independent Quality Management System, supervised by qualified staff provided with all essential equipment and facilities, all changes and findings are fully documented with the quality impact analysis. The effectiveness of the system is constantly monitored and assessed.

How do we ensure Quality in manufacturing?

Developed standards derived from

• Scientific Principles.
• Local & International Regulations
• Industry Trends & Best Practices

• Quality Assurance
• Quality Control

• The drugs are designed and developed in compliance with the cGMP and local regulatory requirements.
  
  
• Each and every step of all the GMP operations is an approved procedure, clearly specified in a written form and complies with cGMP requirements.
  
  
• All necessary controls on starting materials, intermediate products, bulk products and finished products are carried out. Throughout the manufacturing process, in-process checks are 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 equipment and machines, method of manufacture, method of analysis 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 conformed to the required specification and standards.
  
  
• The effectiveness of the quality management 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 compliant. Appropriate preventive and corrective measures are taken promptly in order to prevent recurrence.
  
  
• Training and development is one of the important aspects at AGP. Each and every individual when becomes the member of AGP family and involves in GMP operations undergoes training for Good Manufacturing Practices, Good Lab Practices and Good Warehouse Practices.

• To perform analysis of all the materials there are latest, sensitive, delicate, and dedicated modern lab equipment available in QC lab which is operated by a team of qualified & trained analysts.
  
  
• The analytical documents after the completion of analysis passed through certain independent checks and finally audited by Quality Assurance for its transparency, correctness and completeness.
  
  
• All necessary equipments like Fourier Transmittance Infra Red (FTIR), High Performance Liquid Chromatography (HPLC), Ultra Violet Spectrophotometer 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 available.
  
  
• The stability testing of new products is carried out and their shelf life is determined before placing the product in the market. Products already marketed are also tested for their stability as per predefined procedures.
  
  
• 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 environmental control.
  
  
• Environmental monitoring of sterile and non sterile areas is carried out regularly to ensure the proper ambience.
  
  
• All waste generated throughout the process are disposed through waste management system to keep the environment pollution free.