Welcome to Biological Agri Solutions Association of India
Welcome to Biological Agri Solutions Association of India
The ultimate responsibility for attaining these quality objectives lies primarily at the company management level. However, their attainment also requires the participation and commitment of all staff, at all levels, within the manufacturing organizational facility. In order to achieve these objectives, the manufacturer must have in place a comprehensively designed, adequately resourced and correctly implemented system of quality assurance, incorporating the principles of Good Manufacturing Practice (GMP).
Quality Assurance is a wide-ranging concept covering all aspects of the manufacturing process that individually or collectively influences the quality of a manufactured product. It is the sum total of the arrangements made to ensure that the Agrochemical of biological nature products are consistently manufactured in an appropriate manner to the quality standards required for their intended use. Quality assurance therefore incorporates both GMP and quality control as well as other factors that may be outside the scope of a Code of GMP related to environmental and occupational safety.
Quality assurance requires manufacturers to have in place a quality management system encompassing the organizational structure, responsibilities, procedures, instructions, processes and resources necessary for implementing quality management. That system must ensure that facilities and equipment are suitable for the types of products made, that there are sufficient competent personnel and that appropriate procedures are in place to ensure appropriate quality standards are met. In addition, the system must ensure that all materials involved in the manufacturing process (including raw materials, intermediate materials or samples from any material relevant to product quality) are checked and tested, where necessary, to ensure that they meet required quality standards before they are released for use. Procedures must be in place to ensure that the finished product has been made correctly and meets all the required quality tests before it is released for supply or sale.
The quality management system must be relevant to the needs of the product. It must be fully documented, monitored for effectiveness and incorporate an element of continuous improvement.
Good Manufacturing Practice (GMP) is the part of quality assurance that ensures that products are consistently manufactured, to the quality standards appropriate for their intended Agrochemical of biological nature use and in accordance with their registration particulars and specifications. GMP is concerned with both production and quality control. It is a means of giving consumers confidence that the products meet the required quality standards and are safe and reliable for the purposes for which they are intended.
The basic requirements of GMP are that:
Quality control is the part of GMP that is concerned with specifications, sampling and testing, and with the organization, documentation and release procedures that ensure that the necessary and relevant tests are carried out so that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.
Compliance with GMP ensures that quality is built into the product at the time of manufacture. It requires products to be consistently manufactured in a safe and clean environment, by specified methods, under adequate supervision, with effective quality control procedures, and with a documentation trail that links starting materials, through the various manufacturing processes, to the finished product.
BIOLOGICAL AGRI SOLUTIONS ASSOCIATION OF INDIA
We invite companies who operate in Biostimulants & Biological products for Agriculture sector. (No pharmaceutical, vet or any allied sectors) to join hands with us to take this initiative forward and jointly raise voice against common issues faced for the segment.
We invite companies who operate in Biostimulants & Biological products for Agriculture sector. (No pharmaceutical, vet or any allied sectors) to join hands with us to take this initiative forward and jointly raise voice against common issues faced for the segment.
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