Podcast
Questions and Answers
What is the definition of a 'Pest' according to the text?
What is the definition of a 'Pest' according to the text?
What is the definition of a 'Plant' according to the text?
What is the definition of a 'Plant' according to the text?
What is the definition of 'Procedures' according to the text?
What is the definition of 'Procedures' according to the text?
What is the definition of 'Processing' according to the text?
What is the definition of 'Processing' according to the text?
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What is the definition of 'Quality Assurance' according to the text?
What is the definition of 'Quality Assurance' according to the text?
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What is the definition of 'Repacking' according to the text?
What is the definition of 'Repacking' according to the text?
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What is the purpose of conducting a quality audit according to the text?
What is the purpose of conducting a quality audit according to the text?
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What type of records must be maintained according to the text?
What type of records must be maintained according to the text?
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What should be established and documented for raw materials, labeling, and packaging materials according to the text?
What should be established and documented for raw materials, labeling, and packaging materials according to the text?
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Who can conduct a quality audit according to the text?
Who can conduct a quality audit according to the text?
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What should be established and documented for in-process controls according to the text?
What should be established and documented for in-process controls according to the text?
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Which of the following is NOT mentioned in the text as a type of record that must be maintained?
Which of the following is NOT mentioned in the text as a type of record that must be maintained?
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What is the main purpose of this administrative order?
What is the main purpose of this administrative order?
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What is the primary reason cited for the need to revise the cGMP guidelines?
What is the primary reason cited for the need to revise the cGMP guidelines?
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What is the key factor mentioned for industries to produce good quality, safe, and affordable products?
What is the key factor mentioned for industries to produce good quality, safe, and affordable products?
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What is the main goal of improving and revising the cGMP guidelines?
What is the main goal of improving and revising the cGMP guidelines?
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What is the expected outcome of training BFAD regulators on the new cGMP guidelines?
What is the expected outcome of training BFAD regulators on the new cGMP guidelines?
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What is the main reason cited for the need to review and revise the existing cGMP guidelines?
What is the main reason cited for the need to review and revise the existing cGMP guidelines?
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What physical factors should be monitored to prevent mechanical breakdowns, time delays, and temperature fluctuations contributing to the decomposition or contamination of food?
What physical factors should be monitored to prevent mechanical breakdowns, time delays, and temperature fluctuations contributing to the decomposition or contamination of food?
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How should finished food and raw materials be handled in a receiving, loading, or shipping area?
How should finished food and raw materials be handled in a receiving, loading, or shipping area?
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What should be used to protect against the inclusion of metal or other extraneous material in food?
What should be used to protect against the inclusion of metal or other extraneous material in food?
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How should glass foreign matter be prevented from contaminating food in production areas?
How should glass foreign matter be prevented from contaminating food in production areas?
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What should be used to handle food that can support the rapid growth of undesirable microorganisms?
What should be used to handle food that can support the rapid growth of undesirable microorganisms?
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How should work-in-process be handled to protect against contamination?
How should work-in-process be handled to protect against contamination?
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What should facilities be designed to prevent?
What should facilities be designed to prevent?
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What is strictly forbidden in processing areas, warehouses, offices inside production areas, and laboratories?
What is strictly forbidden in processing areas, warehouses, offices inside production areas, and laboratories?
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Where should the consumption of food by personnel be allowed?
Where should the consumption of food by personnel be allowed?
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What conditions should be maintained in the eating facilities?
What conditions should be maintained in the eating facilities?
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What should establishments and equipment be kept in?
What should establishments and equipment be kept in?
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What may be necessary after cleaning, according to the text?
What may be necessary after cleaning, according to the text?
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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.