Philippines DOH Administrative Order No. 153 S. 2004 Quiz and Flashcards

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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?

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

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

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

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

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

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

To improve the quality system Signup and view all the answers

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

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

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

Specifications Signup and view all the answers

Who can conduct a quality audit according to the text?

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

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

Acceptance criteria 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?

Inventory records Signup and view all the answers

What is the main purpose of this administrative order?

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

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

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

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

Current Good Manufacturing Practice (cGMP) Signup and view all the answers

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

To allow for more consistent industry implementation and regulatory inspection Signup and view all the answers

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

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

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

To ensure that the guidelines are consistent with international best practices 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?

Humidity, aw, and pressure Signup and view all the answers

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

They should be separated to prevent contamination Signup and view all the answers

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

Sieves, traps, magnets Signup and view all the answers

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

By excluding the use of breakable glass in production areas Signup and view all the answers

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

A specified manner that prevents contamination Signup and view all the answers

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

It should be protected against contamination Signup and view all the answers

What should facilities be designed to prevent?

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

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

Eating food Signup and view all the answers

Where should the consumption of food by personnel be allowed?

In eating facilities Signup and view all the answers

What conditions should be maintained in the eating facilities?

Hygienic conditions and practices Signup and view all the answers

What should establishments and equipment be kept in?

An appropriate state of repair and condition Signup and view all the answers

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

Disinfection 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.

Philippines Department of Health Administrative Order No. 153 S. 2004