BASAI STATEMENT

ADHERENCE TOWARDS MANUFACTURING QUALITY AND
OCCUPATIONAL SAFETY
UNDER
GOOD MANUFACTURING PRACTICE ( GMP )

Most of the Agrochemical of biological nature products are subject to a registration process that requires them to be fit for their intended use and to not place treated plants or animals or users at risk due to inadequate safety, quality or efficacy. Such products must be manufactured in such a way that they comply with their registered particulars and that there is batch-to-batch consistency.

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:

all manufacturing processes are clearly defined, are systematically reviewed in the light of experience, and shown to be capable of consistently producing Agrochemical ( Pesticides & Chemicals ) of biological nature products that comply with their specifications and the required quality standards
critical steps of manufacturing processes and significant changes to the processes are validated
all necessary facilities for GMP are provided, including:
(i) appropriately qualified, trained or experienced personnel
(ii) adequate premises and space
(iii) suitable equipment and services
(iv) correct materials, containers and labels
(v) approved procedures and instructions
(vi) suitable storage and transport
(d) instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided
(e) operators are trained to carry out procedures correctly
(f) records are made manually and/or by recording instruments during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected; any significant deviations are fully recorded and investigated
(g) records of manufacture, including distribution, that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form
(h) a system is available to recall any batch of product from sale or supply
(i) complaints about marketed products are examined, the causes of quality defects investigated and appropriate corrective and preventive measures are taken in respect of the defective products and to prevent re-occurrence.

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

incorporating the principles of Good Manufacturing Practice (GMP)
establishing Codes for GMP to address environmental and occupational safety concerns

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.

AT A GLANCE

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SCOPE OF WORK

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We offer full range of garage services to vehicle owners in Tucson. Our professionals know how to handle a wide range of car services. We can handle any problem on both foreign and domestic vehicles.

We make auto repair and maintenance more convenient for you
We are a friendly, helpful and professional group of people
Our professionals know how to handle a wide range of car services
We get the job done right — the first time
Same day service for most repairs and maintenance

BASAI GMP Statement

BASAI STATEMENT

ADHERENCE TOWARDS MANUFACTURING QUALITY AND OCCUPATIONAL SAFETY UNDER GOOD MANUFACTURING PRACTICE ( GMP )

AT A GLANCE

SCOPE OF WORK

ADHERENCE TOWARDS MANUFACTURING QUALITY AND
OCCUPATIONAL SAFETY
UNDER
GOOD MANUFACTURING PRACTICE ( GMP )