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

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.