Philippines Department of Health Administrative Order No. 153 S. 2004
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Questions and Answers

What is the definition of a 'Pest' according to the text?

  • Any objectionable animals or insects including birds, rodents, flies, and larvae (correct)
  • Any objectionable animals or insects including only birds and rodents
  • Any objectionable animals or insects excluding birds and rodents
  • Any objectionable animals or insects including only flies and larvae
  • What is the definition of a 'Plant' according to the text?

  • The building or the facilities or parts thereof, used for or in connection to the manufacturing, packing, labeling or holding of food products (correct)
  • The building or the facilities or parts thereof, used for or in connection to the manufacturing, packing, or labeling of food products
  • The building or the facilities or parts thereof, used for or in connection to the packing, labeling or holding of food products
  • The building or the facilities or parts thereof, used for or in connection to the manufacturing or holding of food products
  • What is the definition of 'Procedures' according to the text?

  • Description of the operations to be executed, the precautions to be implemented directly or indirectly related to the repacking of food products
  • Description of the operations to be executed, the precautions to be implemented directly related to the manufacture of food products
  • Description of the operations to be executed, the precautions to be implemented directly related to the manufacture and the repacking of food products
  • Description of the operations to be executed, the precautions to be implemented directly or indirectly related to the manufacture and the repacking of food products (correct)
  • What is the definition of 'Processing' according to the text?

    <p>The part of production cycle starting from weighing of raw materials to the obtaining of a bulk product</p> Signup and view all the answers

    What is the definition of 'Quality Assurance' according to the text?

    <p>The activity of providing the evidence needed to establish confidence that the quality function is being performed adequately</p> Signup and view all the answers

    What is the definition of 'Repacking' according to the text?

    <p>Process of packaging or changing of container, wrapper (that may include or not a changing of label) in furtherance of distribution of food</p> Signup and view all the answers

    What is the purpose of conducting a quality audit according to the text?

    <p>To improve the quality system</p> Signup and view all the answers

    What type of records must be maintained according to the text?

    <p>Records of major equipment use, cleaning, sanitation, and/or sterilization and maintenance</p> Signup and view all the answers

    What should be established and documented for raw materials, labeling, and packaging materials according to the text?

    <p>Specifications</p> Signup and view all the answers

    Who can conduct a quality audit according to the text?

    <p>Either outside or independent specialists or an internal audit team designated by the management</p> Signup and view all the answers

    What should be established and documented for in-process controls according to the text?

    <p>Acceptance criteria</p> Signup and view all the answers

    Which of the following is NOT mentioned in the text as a type of record that must be maintained?

    <p>Inventory records</p> Signup and view all the answers

    What is the main purpose of this administrative order?

    <p>To align the Philippines' current good manufacturing practice (cGMP) with international standards</p> Signup and view all the answers

    What is the primary reason cited for the need to revise the cGMP guidelines?

    <p>The advent of globalization has increased competition for local food manufacturers</p> Signup and view all the answers

    What is the key factor mentioned for industries to produce good quality, safe, and affordable products?

    <p>Current Good Manufacturing Practice (cGMP)</p> Signup and view all the answers

    What is the main goal of improving and revising the cGMP guidelines?

    <p>To allow for more consistent industry implementation and regulatory inspection</p> Signup and view all the answers

    What is the expected outcome of training BFAD regulators on the new cGMP guidelines?

    <p>BFAD regulators will be able to improve their industry inspection and performance</p> Signup and view all the answers

    What is the main reason cited for the need to review and revise the existing cGMP guidelines?

    <p>To ensure that the guidelines are consistent with international best practices</p> Signup and view all the answers

    What physical factors should be monitored to prevent mechanical breakdowns, time delays, and temperature fluctuations contributing to the decomposition or contamination of food?

    <p>Humidity, aw, and pressure</p> Signup and view all the answers

    How should finished food and raw materials be handled in a receiving, loading, or shipping area?

    <p>They should be separated to prevent contamination</p> Signup and view all the answers

    What should be used to protect against the inclusion of metal or other extraneous material in food?

    <p>Sieves, traps, magnets</p> Signup and view all the answers

    How should glass foreign matter be prevented from contaminating food in production areas?

    <p>By excluding the use of breakable glass in production areas</p> Signup and view all the answers

    What should be used to handle food that can support the rapid growth of undesirable microorganisms?

    <p>A specified manner that prevents contamination</p> Signup and view all the answers

    How should work-in-process be handled to protect against contamination?

    <p>It should be protected against contamination</p> Signup and view all the answers

    What should facilities be designed to prevent?

    <p>Access by pests and contamination of food, water, equipment, and premises</p> Signup and view all the answers

    What is strictly forbidden in processing areas, warehouses, offices inside production areas, and laboratories?

    <p>Eating food</p> Signup and view all the answers

    Where should the consumption of food by personnel be allowed?

    <p>In eating facilities</p> Signup and view all the answers

    What conditions should be maintained in the eating facilities?

    <p>Hygienic conditions and practices</p> Signup and view all the answers

    What should establishments and equipment be kept in?

    <p>An appropriate state of repair and condition</p> Signup and view all the answers

    What may be necessary after cleaning, according to the text?

    <p>Disinfection</p> Signup and view all the answers

    Study Notes

    Definitions

    • Pest: any objectionable animals or insects, including birds, rodents, flies, and larvae.
    • Plant: the building or facilities used for manufacturing, packing, labeling, or holding food products.
    • Premises: the plant and grounds within the industrial establishment.
    • Procedures: descriptions of operations to be executed, precautions to be implemented directly or indirectly related to food manufacture and repacking.
    • Processing: the part of the production cycle starting from weighing raw materials to obtaining a bulk product.
    • Production: all operations involved in preparing a product, from acquiring starting materials to completing a finished product.
    • Quality Assurance: providing evidence to establish confidence that the quality function is being performed adequately.
    • Quality Control Operation: a planned and systematic procedure to prevent food adulteration and achieve quality and safety.
    • Raw Material: all substances employed in processing a finished product.
    • Repacking: changing the packaging or container, including labeling, for distribution of food.

    Documentation and Records

    • Establish a procedure for retaining documents, including development history reports, scale-up reports, technical transfer reports, process validation reports, training records, production records, control records, and distribution records.
    • Specify the retention period for these documents.
    • Records of major equipment use, cleaning, sanitation, and/or sterilization and maintenance shall show date, time, product, batch number, and person who performed the cleaning and maintenance.

    Quality Audits

    • A quality audit consists of an examination and assessment of all or part of a quality system to improve it.
    • Audits may be conducted by outside or internal specialists or an internal audit team designated by management.
    • Audits may extend to suppliers and contractors, if necessary.
    • A report should be made at the completion of each quality audit.

    Warehousing and Distribution

    • Establish procedures for sanitary handling of food on storage and distribution.
    • Ensure proper handling of food to prevent contamination.

    Current Good Manufacturing Practice (cGMP)

    • cGMP is a key factor for industries to produce good quality, safe, and affordable products.
    • The cGMP should be improved to align with international standards (e.g., USDA and EU cGMP).
    • Equipment should be taken apart for thorough cleaning, where necessary.

    Physical Factors and Contamination

    • Monitor physical factors like time, temperature, humidity, aw, pH, pressure, flow rate, and manufacturing operations to ensure they do not contribute to food decomposition or contamination.
    • Handle food that can support rapid growth of undesirable microorganisms in a specified manner to prevent contamination.
    • Prevent contamination of food by raw materials, other ingredients, or refuse in receiving, loading, or shipping areas.
    • Use sieves, traps, magnets, and electronic metal detectors to protect against metal or other extraneous material in food.
    • Prevent glass and foreign matter from contaminating food by excluding breakable glass in production areas.

    Facilities and Hygiene

    • Design facilities to prevent access by pests and possible contamination of food, potable water, equipment, building, or roadways on the premises.
    • Provide eating facilities, and ensure hygienic conditions and practices are maintained in these facilities.
    • Establish procedures for general maintenance of the plant and its premises, including keeping establishments and equipment in an appropriate state of repair and condition.
    • Clean and maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition.

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    Description

    Explore the revised guidelines on current good manufacturing practice for food in the Philippines Department of Health's Administrative Order No. 153 S. 2004.

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