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Quality Management

The AGP Quality Management has established a comprehensive Quality System that encompasses all applicable standards/procedures and their implementation, thus assuring cGMP, regulatory compliance and continuous improvement.

 

It is the responsibility of every AGP team member to respect and follow the aforementioned quality system in order to meet current and future challenges.

QUALITY

AGP’s slogan is “we value life”; and fulfillment of the said commitment by each employee will assist the company to achieve our aim, i.e. provision of safe and quality   products to everyone at reasonable prices.

 

Quality is of paramount importance in AGP operations. We ensure the quality of drugs manufactured by AGP are in compliance with local regulatory, cGMP requirements and International Quality Standards and does not place patient at risk due to inadequate safety, quality or efficacy.

 

To achieve the quality objective, we have designed and comprehensively implemented an independent Quality Management System, supervised by qualified staff provided with necessary 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 Trend & Best Practices

At AGP the Quality Management is divided in to two sections on the basis of their functions.

  •  Quality Assurance
  •  Quality Control

QUALITY CONTROL

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

  •  To perform analysis of all the materials there are latest, precise and dedicated modern lab equipment available in QC lab operated by a team of qualified & trained analysts.
  •  The analytical documents after the completion of analysis are passed through certain independent checks and finally audited by Quality Assurance for transparency, correctness and completeness.
  •  The necessary equipment like Atomic Absorption (AA) Fourier Transmittance Infra-Red (FTIR), High Performance Liquid Chromatography (HPLC), Ultra Violet Spectrophotometer (Double Beam), Electrical Kjeldahl apparatus 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.
  •  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.

Developed Quality procedures related to standards;

  •  People
  •  Quality
  •  Production
  •  Material
  •  Laboratories
  •  Facilities, Utilities & Equipment

QUALITY ASSURANCE

AGP Quality Assurance ensures:

  •  The drugs are designed and developed in compliance with the cGMP, local regulatory requirements and international quality standards.
  •  Each and every step of all the GMP operations is an approved procedure, clearly documented and compliant to cGMP requirements.
  •  Vendor Assurance is one of the key functions where all the suppliers of the raw/ packaging materials are audited by QA.
  •  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.
  •  Ensures that all the new GMP/GLP related equipment purchases are qualified for design, installation, operation and performance.
  •  Finished products are not supplied or sold until certified by the authorized personnel that the batch has been produced and controlled in accordance with the requirements of cGMP and conform to the required specification and standards.
  •  The effectiveness of the quality management system is checked at appropriate intervals through self-inspection and audit.
  •  All products 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.
  •  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/GLP/GWP operations undergoes training for Good Manufacturing Practices, Good Lab Practices and Good Warehouse Practices.

EHS POLICY

AGP ensures that the Production Operation is carried out in the compliance with the local regulations and company standards. AGP Believes in involvements of its employees at every step and provides adequate training to its employees for continual improvement at work place. The plant and the manufacturing processes are operated in a manner where environment, health and safety are not compromised. Our objectives are to eliminate all injuries, illness, prevent health and environment impacts and reduce waste and emissions.

At AGP safety is the most important day to day consideration while carrying out the Technical Operations. AGP believes that accidents are preventable through attention to hazards and appropriate action by each individual.

 

AGP continually strive for a healthy, accident free and environmentally sound place while providing the scientific and technical excellence needed to meet national missions.

 

The ultimate goal of AGP is to provide a pollution and accident free environment to company employees and continuous monitoring of all types of potential hazards in compliance with EPA (Environment Protection Agency) act of Pakistan and with ISO 14001 guidelines.

 

The AGP management commits itself to ensure that everyone has easy access to safe, effective, and quality products that are developed, manufactured, stored, and marketed in accordance with the regulatory requirements and company values.

 

As Quality is our core value, the company asserts that it is maintained at all levels. High standards of quality applied across the organization enable us to ensure patient safety and meet the expectations of customers and other stake holders.