Quality is of paramount importance in AGP operations. We ensure the quality of drugs manufactured by AGP are in compliance with local regulatory, cGMP/cGLP 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
Local & International Regulations
Industry Trends & Best Practices
Developed Quality procedures related to standards;
Facilities, Utilities & Equipments.
At AGP the Quality Management is divided in to two sections on the basis of their functions.
AGP Quality Assurance ensures:
The drugs are designed and developed in compliance with the cGMP, cGLP 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 equipments purchased are qualified for design, installation, operation & 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 /cGLP and conform 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 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.
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 which is 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 equipments 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.
AGP assumes the responsibility for the quality of the drugs manufactured by it to ensure that they are fit for their intended use, comply with the local regulatory and cGMP requirements and do not place patients at risk due to inadequate safety, quality or efficacy. The manufacturing operations and quality management system of AGP are fully in compliance with the ISO 9001:2000(E) requirements.
AGP protects people and environment by meeting the local regulations. AGP operates the plant and the manufacturing processes in a manner where Environment, Health and Safety are not compromised. Our objectives are to eliminate all injuries, prevent health and environmental impacts and reduce waste and emissions.
AGP Management provides good working environment and makes it sure that all the required resources are available and proper training is provided to the staff and strive ceaselessly day after day to improve their skills.
Every AGPian is a part of quality management and well capable of doing the job right the first time.