Good Manufacturing Practice (GMP) Governing the Manufacture of Specific Household/Urban Hazardous Substances such as Household Pesticide Products
Pursuant with the provisions of R.A. 9711 and its implementing rules and regulations and Administrative Order No. 2014-0038, the Food and Drug Administration (FDA) hereby set revised rules and regulations on the licensing and registration of household pesticide, institutional use pesticide and/or public health pesticide products.
Household pesticide, institutional use pesticide and/or public health pesticide products are generally toxic and incompatible with other forms of food and medicinal products, consequently, these products must be manufactured in a dedicated area under rigorous precautions to prevent cross contamination due to some active materials present are also used for agricultural chemicals. Precautions may include specific equipment that is adequately separated from other processing units and the use of separate scheduling and validated cleaning procedures for incompatible products. Special constructed storage vessels must be used for raw materials and solvents, properly labeled with outdoor storage under acceptable conditions such as temperature, humidity, etc.
Republic Act No. 6969 also known as “Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990” is the policy of the State concerning the regulation of chemicals including considerations in manufacturing design and safety issues such as the explosion hazards of excessive dust generation and the possible inhalation of workers and the surrounding community.
Good Manufacturing Practices (GMP) are designed to assure that health products are produced under hygienic conditions. Manufacturers are responsible for the incorporation of GMP in the Quality Management System (QMS). Quality assurance is planned with systematic actions necessary to provide adequate confidence on the quality of household pesticide, institutional use pesticide and/or public health pesticides ensuring the safety and efficacy of the products. Standards required for the intended use, quality control as well as other factors outside the scope such as environmental and occupational safety controls and regulation as may be required by the Department of Environment and Natural Resources (DENR), and other treaties that the Philippines is a signatory.
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This Order sets to provide guidance for the pesticide industry in compliance with GMP for household pesticide, institutional use pesticide and/or public health pesticide products so as to secure license to manufacture such products in order to ensure the safety and quality of products, and to protect the welfare of the general public.
The Administrative Order applies to all establishments and entities involved in the manufacture of household pesticide, institutional use pesticide and/or public health pesticide products. It shall also include all individuals dealing or handling household pesticide, institutional use pesticide and/or public health pesticides.
- DEFINITON OF TERMS
For the purpose of these guidelines, below are the terminologies defined:
- Batch means a quantity of any household pesticide, institutional use pesticide and/or public health pesticide product produced in a given cycle of manufacture that is uniform in character and quality.
- Batch Number means a designation in numbers or letters or combination thereof that identifies the complete history of batch, quality control and distribution.
- Bulk Product means any processed product which will have to undergo the packaging operation in order to become a finished product.
- Calibration means a combination of checking an instrument and adjusting it to bring it within its limit for accuracy according to recognized standards.
- Component means any ingredient intended for use in the manufacture of a product, which include raw and packaging materials, including those that may not appear in the finished product.
- Contract Manufacture is the manufacture in part or whole of a product by one (or more) manufacturer(s) (Toll Manufacturer) for another party (Trader).
- Cross Contamination means a contamination of a material or of a product with another material or product.
- Documentation means all written procedures, instructions and records involved in the manufacture and quality control of products.
- Facilities refer to the building, premises and equipment necessary in the manufacture of household pesticide, institutional use pesticide and/or public health pesticide
- Finished Product means a product which has undergone all stages of manufacturing operations and is ready for use.
- Good Manufacturing Practice (GMP) is the part of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use. It is thus concerned with both manufacturing and quality control procedures.
- Household/Urban Hazardous Substances means:
- Any substance or mixture of substances intended for individual or limited purposes and which is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, generates pressure through decomposition, heat or other means, if such substance or mixture of substances may cause substantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children, xxxxxxxxxx;
- Any substance which the FDA finds to be under the categories enumerated in clause (12.1) of this paragraph;
- xxxxxxxxxx; and
- This term shall not apply to food, drugs, cosmetics, devices or to substances intended for use as fuels when stored in containers and used in the heating, cooking or refrigeration system of a house, but such term shall apply to any article which is not in itself an agricultural pesticide but which is a hazardous substance, as construed in paragraph (12.11), by reason of bearing or containing such harmful substances described therein.
- In-Process Control means checks and tests instituted and carried out in the course of the manufacture of a household pesticide, institutional use pesticide and/or public health pesticide product including checks and tests done to the environment and equipment in order to ensure that the end product will comply with its specification.
- Manufacture or Manufacturing means the complete set of activities to produce a product that comprise production and quality control from acquisition of all materials through processing and subsequent packaging to the release for distribution of the finished product.
- Master Formula means a document or set of documents specifying the starting materials with their quantities together with a description of the procedures and precautions required to produce a specified quantity of a bulk product as well as the processing instructions, including the in-process controls.
- Packaging is the part of the production cycle applied to a bulk product to obtain the finished product.
- Packaging Material means any material, including printed material, employed in the packaging of a product, including any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
- Pesticide refers to any substance, or mixture of substances, or microorganisms including viruses, intended for repelling, destroying or controlling any pest, including vectors of human or animal disease, nuisance pests, unwanted species of plants or animals causing harm during or otherwise interfering with the production, processing, storage, transport, or marketing of food, agricultural commodities, wood and wood products or animal feeding stuffs, or which may be administered to animals for the control of insects, arachnids or other pests in or on their bodies. The term also includes pesticide synergists and safeners, where they are integral to the satisfactory performance of the pesticide.
A pesticide, for the purpose of this Order, shall be specific to:
- Household Pesticide – refers to a pesticide used for the control of pests in homes, yards and gardens, domestic and/or commercial establishments such as schools, malls, condominiums, hospitals, buildings, manufacturing sites, warehouses, golf courses, etc. but shall exclude chemicals used in commercial agricultural production. The term also refers to any material or mixture of substance used for the control of insect pests, rodents, plant diseases, and weeds that are found in places of human habitation, work and recreation. Examples of insect pests are flies, mosquitoes, cockroaches, ants, termites, bedbugs, and others.
Household pesticides shall include products such as, but not limited to, mosquito coils, aerosol sprays, insect repellents for personal use, rodenticides concentrates and baits, cockroach sprays and baits, and others.
Household pesticides can be classified as follows:
- For Institutional Use – refer to household pesticide products intended to be used or applied to institutions such as but not limited to schools, malls, condominiums, hospitals, buildings, manufacturing sites, warehouses, golf courses, etc. under a pest control program.
- For Public Health Use – refer to household pesticide products used in the control of pests of public health significance and for vector control such as but not limited to dengue control, malaria control, etc.
- Ready-to-Use – refer to household pesticide products that can be sold or bought over-the-counter including ready-to-use formulations. The labels of these ready-to-use household pesticides shall indicate the phrase “Keep out of reach of children” and storage shall be under lock and key.
- Procedure means the description of the operations to be executed, including the precautions to be implemented directly or indirectly related to the manufacture of a finished product.
- Processing means the part of production cycle starting from weighing of raw materials to the obtaining of a bulk product.
- Production means all operations involved in the preparation of a product, starting from acquisition of starting materials through processing and packaging, to its completion as finished product.
- Product Recall means the process of withdrawing one or more batches or all of a certain product from market distribution.
- Public Health Pesticide refers to a pesticide that is used in the control of pests of public health significance. They include vector control pesticides, and professional pest management pesticides (i.e. institutional use pesticides used by pest control operators). For the purpose of this guideline, public health pesticides do not include disinfectants.
- Quality Assurance means the activity of providing the evidence needed to establish confidence that the quality function is being performed adequately.
- Quality Control means all control measures taken during manufacturing designed to ensure that finished products consistently conform to established specifications.
- Quarantine means the act of holding a material for use or a product of a packaging or distribution by setting it apart or by a system fully validated pending a decision of its release or rejection.
- Raw Material means any substance going into or involved in the processing of a finished product.
- Rejected means the status of material or product which is not permitted to be used for processing, packaging or distribution.
- Reprocessing means the reworking of all or part of a batch of product of an unacceptable quality from a defined step of production in order its quality may be rendered acceptable by one or more additional operations.
- Returned Product means any finished product which is already in distribution and sent back to the manufacturer or distributor due to complaint, damage or other reasons such as the condition of the container or package which may cast doubt on the product quality and safety.
- Safety Data Sheet (SDS) refers to a document that provides important physical characteristics, ecological, safety and toxicological information on chemical substances or mixtures of ingredients used at the workplace, transported or maybe utilized by the consumer.
- Sanitation means measures taken to preclude contamination of the processing equipment and/or area so as to prevent contamination of the bulk or finished product.
- Specifications refer to the documents that describe the requirements to which the material, product or service has to conform.
- Starting Materials refer to raw/chemical materials and packaging materials used in the production of a finished product.
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