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PHILIPPINE FDA REQUIREMENTS FOR ISSUANCE OF LICENSE TO OPERATE (LTO) AS FOOD MANUFACTURERACKER

1. FULL COMPREHENSION OF ADMINSTRATIVE ORDER 153 S 2004

A. REVISED GUIDELINES ON GOOD MNUFACTURING PRACTICE IN MNUFACTURING, PACKING, REPACKING,


OR HOLDING FOOD.

B. BASED ON ADMINISTRATIVE ORDER NO. 208 S 1974: HUMAN FOODS; CURRENT GOOD
MANUFACTURING PRACTICE(SANITATION) IN MANUFACTURE, PROCESSING, PACKING OF HOLDING.

OUTLINE OF AO NO 153 S 2004

GENERAL GUIDELINES

 PREMISES

 EQUIPMENT

 SANITATION AND HYGIENE

 MAINTENANACE AND SANITATION

 PRODUCTION AND PROCESS CONTROLL

 QUALITY CONTROL

 DOCUMENTATION

 QUALITY AUDITS

 WAREHOUSING AND DISTRIBUTION

 PRODUCT RECALL

 RETENTION OF SAMPLES

2. DOCUMENTARY REQUIREMENTS ( QWP-008-020-ANNEX-030

3. TECHNICAL REQUIREMENTS

FOOD SAFETY MANUAL

PARTS/COMPONENTS OF FOOD SAFETY MANUAL

PARTS:

 MANAGEMENT FOOD SAFETY PROGRAM

 FOOD SATETY TEAM

 PREREQUISITE PROGRAMS

 FOOD SAFETY PLAN


MAJOR COMPON

ENTS/MANUAL PART:

 DOCUMENTS AND RECORDS

MANAGEMENT FOOD SAFETY PROGRAM

FOOD SAFETY MANAGEMENT COMMITMENT

1.1 DEFINITION OF TERMS


1.2 COMPANY FOOD SAFETY POLICY
 DETAILS CLEAR OBJECTIVES AND TARGETS OF SUCCESS OF MANAGEMENT OF MANAGEMENT
TOWARDS PRODUCI NG SAFE QUALITY AND LEGAL PRODUCTS.
 POLICY MUST BE SIGN BY MANAGEMENT AND BY MANAGEMENTAND POSTED PER SITE.
 CLEARLY COMMUNICATED TO ALL EMPLOYESS
EXAMPLE OF FOOD SAFETY POLICY
COMPANY __________ BELIEVES THAT SUCCESS DEPENDS ON THE SUPPLY OF HIGH QUALITY
PRODUCTS, PACKAGES AND SERVICES THAT MEE OREXCEED CUSTOMER AND CONSUMER
EXPECTATION OF OUR PREMIUM BRANDS. FUNDAMENTAL TO THIS BELIEF IS THE RESPONSIBILITY TO
ENSURE THE FOOD SAFETY AND LEGALITY OF ALL PRODUCTS THAT COMPANY _________
MANUFACTURE AND SELL
1.3 SCOPE (PRODUCTS, PROCESSES, LOCATION AND MAJOR COSTUMERS)
1 DESCRIBE IN GENERAL TERMS PRODUCTS, PROCESSES AND OTHER ACTIVITIES NECESSARY THE
QUALITY, AND SAFETY OF FOOD AT ALL STAGES OF PRODUCTION IN A SPECIFIC LOCATION PER FOOD
BUSINESS FOR ITS COSTUMERS.
2 CITE FOOD SAFETY PROGRAMS LIKE HACCP USED FOR THE FOOD SAFETY PLAN
3 CITE PREREQUISITES QUALITY PROGRAMS(CGMP) OF HACCP PROGRAM.
EXAMPLE SCOPE
 THIS FOOD SAFETY MANUAL COVERS THE FOLLOWING __PRODUCT NAME_______;
PRODUCED AT _____ADDRESS_____
 GMP AND HACCP PROGRAMS COVERS ALL PROCESSES, MICROWAVE DRYING, PACKING
AND ALL OTHER RELATED STEPS DONE BY THE COMPANY _____INSERT BUSINESS
NAME____ . THE MAJOR COSTUMER OF THE ____ INSERT BUSINESS NAME___
PRODUCTS INCLUDE LEADING FOOD MARKETS AND RETAIL STORES LIKE ______ INSERT
COSTUMERS____

1.4 FOOD SAFETY COMMITIMENT STATEMENTS


A COMPANY SHALL COMMITTED TO CONTINUALLY MAINTAIN THE REPUTATION OF ITS BRANDS AND ENSURE
CONFIDENCE IN ITS PRODUCTS THROUGH THE DEVELOPMENT AND IMPLEMENTATION OF QUALITY AND
FOOD SAETY SYSTEMS, STANDARDS AND PRACTICES.
EXAMPLE : COMMITMENT STATEMENT
BRANCORP IS COMMITTED IN MAINTAINING ITS FOOD SAFETY MANAGEMENT SYSTEM SO THAT
 PRODUCTS PRODUCED AND SOLD ARE QUALITY, SAFE AND SUITABLE FOR HUMAN
CONSUMPTION
 THE BUSINESS COMPLIES WITH THE REQUIREMENTS OF INTERNATIONAL AND NATIONAL
STANDARD FOR FOOD SAFETY.
 THE MANAGEMENT FACILITATE CONTINUAL IMPROVEMENT OF FOODSAFETY MANAGEMENT
SYSTEM.

1.5 REFERENCES: FOOD SAFETY GUIDELINES AND STANDARDS


COMPANY SHOULD HACE HARD/ELECTRONIC COPIES OF REFERENCE GUIDELINES/STANDARD
1) PHILIPINE FDA
a) ADMINISTRATIVE ORDER NO. 208 S 1974
b) ADMINSTRATIVE ORDER 153S 2004
c) BUREAU CIRCULAR NO 10 S. 2006

1.6 ORGANIZATIONAL STRUCTURES AND RESPONSIBILITIES


 A current and accurate ORGANIZATIONAL CHART SHALL BE AVAILAB,E WHICH IDENTIFIES ALL THE
MANAGEMENT AND STAFF POSITIONS WITHIN YOUR ORGANIZATION
 POSITON DESCRIPTION SHALL BE AVAILABLE FOR ALL POSITIONS ON THE ORGANIZATIONAL CHART
WHICH HAVE RESPONSIBILITY FOR FOOD SAFETY AND MAINTENANCE OF THE GMP AND HACCP
SYSTEM.

FOOD SAFETY RESPONSIBILITIES

 ENSURE THAT EVERYONE WHO HANDES FOOD HAS THE SKILLS AND KNOWLEDGE NEEDED TO
PROVIDE SAFE FOOD AND MEET ALL FOOD SAFETY REQUIREMENTS.
 FOOD SAFETY EMPLOYESS MUST UNDERSTANDS AND CARRIES OUT THEIR ROLES AND
RESPONSIBILITIES.

PLANT MANAGER
FOOD SAFETY RESPONSIBILITIES:
 ENSURE THAT EMPLOYEES WHO PHANDLES FOOD HAS THE SKILLS AND KNOWLEDGE NEEDED TO
PROVIDE SAFE FOOD AND MEET ALL FOOD SAFETY REQUIREMENTS
 ENSURE THAT ALL CONCERNED EMPLOYEES ARE TRAINED IN THE FOOD HANDLING TECHNIQUES AND
THE REQUIREMENTS OF FOOD SAFETY.
 HELP IMPLEMENT AND REVIEW THE FOOD SAFETY POLICY REGULATIONS AND PRACTICES
 ENSURE THAT ALL RECORDS AND SYSTEMS IN THE RELATION TO FOOD SAFETY ARE MAINTAINED AND
FILED.

1.7 MANAGEMENT FOOD SAFETY SYSTEM REVIEWS


MANAGEMENT REVIEW
COMPANY SHALL DEMONSTRATE FOOD SAFETY CONTROL EFFECTIVENESS IN THE LOCATION COVERED BY THE
MANUAL. BASIS FOR SENIOR MANAGEMENT MEETINGS WILL INCLUDED THE FOLLOWING
DEFINE FOOD SAFETY POLICY, COMMITMENT AND SCOPE
 CREATE AND TRAIN THE FOOD SAFETY TEAM
 MANAGEMENT REVIEWS BASED ON
 RESULTS OF AUDITS
 CHANGE LEGISLATION AND/OR STANDARD, BEST PRACTICES ETC.
 FOOD SAFETY MAJOR INCIDENTS
 NEW FOOD SAFETY CAMPAINS AND INITIATIVES
 ORGANIZATION AND BUSINESS CHANGES
 CUSTOMER COMPLAINTS AND REJECTIONS
 SHALL MANAGE MANAGEMENT REVIEW RECORDS INCLUDING
 MANAGEMENT REVIEW RECORD
 MINUTES OF THE MEETING
 SENIOR MANAGEMENT IMPLEMENTATION PLAN
 DOCUMENT HISTORY AMENDMENT
 SAMPLE MANAGEMENT RECORDS
 FSM 001- MEETING REVIEW RECORD
 FSM 002 -MINUTES OF THE MEETING
 FSM 003-SENIOR MANAGEMENT IMPLEMENTATION PLAN
 FSM004-DOCUMENT HISTORY AMENDMENT

FOOD SAFETY SYSTEM

 MINUTES OF THE MEETING


 SENIOR MANAGEMENT IMPLEMENTATION PLAN

FOOD SAFETY TEAM

 ORGANIZATION /MEMBERSHIP- TRAINING


o MULTI-DICIPLINARY MEMBERS HAVING KNOWLEDGE, SKILLS AND CAPABILITIES RELEVANT TO
FOOD SAFETY
 TRAININGS
 TRAINED IN OPERATION THEY PERFORMED IN ACCORDANCE TO GMP AND
HACCP AND OTHER RELEVANT FOOD SAFETY PROGRAMS
 EMPLOYEES PERFORMANCE SHALL APPRAISED TO DETERMINE CONTINUED
AND FURTHER TRAINING
 FOOD SAFETY TEAM CORE RESPONSIBILITIES
o MANAGEMENT FOOD SAFETY PROGRAM
 DEVELOP AND IMPLEMENT FOOD SAFETY POLICY
 APPOINTMENT OF FOOD SAFETY TEAM LEASDER CORE MEMBERS
 TRAIN FOOD SAFETY TEAM
 PROVIDE RESOURCES
o FOOD SAFETY TEAM LEADER QND CORE MEMBER
 DEVELOP FOOD SAFETY PLAN
 DEVELOP AND IMPLEMENT PREREQUISITE
 PROGRAMS(RGMP)
 DEVELOP AND IMPLEMENT FOOD SAFETY PROGRAMS (HACCP)
 CONDUCT FOOD SAFETY TRAININGS
 BE RESPONSIBLE FOR INTERNAL/EXTERNALAUDITS
 ENSURE PRODUCT TRACEABILITY AND CONTROL
 FEEDBACK TO MANAGEMENT RE DEVIATION AND CORRECTIVE ACTIONS
o ALL EMPLOYEES
 HANDS ON OPERATION OF FOOD SAFETY PROGRAMS
 MONITORING OF FOOD SAFETY PROGRAMS
 IMPLEMENT OF CORRECTIVE ACTIONS PER DEVIATION
 RECORD KEEPING
 FEEDBACK OF DEVIATION

 FOOD SAFETY TEAM RESPONSIBILITIES IN RELATION TO IMPLEMENTATION OF FOOD SAFETY


PROGRAM(HACCP)
 DESCRIBE THE PRODUCTS/PROCESSES COVERED BY FOOD SAFETY PLAN
 IDENTIFY INTENDED USE (FROM CODEX ALIMENTARIUS)
 CONDUCT FLOW DIAGRAM(FROM CODEX ALIMENTARIUS)
 ON-SITE CONFIRMATION OF FLOW DIAGRAM (FROM CODEX ALIMENTARIUS)
 LIST ALL POSSIBLE HAZARD; CONDUCT A HAZARD
 ANALYSIS; CONSIDER CONTROL MEASURES
 DETERMINE CRITICAL CONTROL POINTS
 ESTABLISH CRITICAL LIMITS
 ESTABLISH A MONITORING SYSTEM FOR EACH CCP
 ESTABLISH CORRECTIVE ACTIONS
 ESTABLISH VERIFICATION PROCEDURES
 ESTABLISH DOCUMENTATION AND RECORD KEEPING

PREREQUISITE PROGRAMS (SOP AND SSOP)

3.1 PREMISES
3.2 EQUIPMENT
3.3 SANITATION AND HYGIENE (EMPLOYEE AND SANITATION FACILITIES)
3.4 MAINTENANCE AND SANITATION
3.5 PRODUCTION AND PROCESS CONTROLS
3.6 QUALITY CONTROL
3.7 DOCUMENTATION
3.8 QUALITY AUDITS
3.9 WAREHOUSING
3.10 PRODUCT RECALL
3.11 RETENTION OF SAMPLES

3. PREREQUISITE PROGRAMS (cGMPs)


o THE COMPANY SHALL ESTABLISH, IMPLEMENT AND MAINTAIN PREREQUISITE PROGRAMS BASED ON
CGMP AIMED AND ENSURING THAT PRODUCTS ARE CONSISTENTLY MANUFACTURED, PACKED AND
HELD TO QUALITY APPROPRIATE FOR THE INTENDED USE.
o CONSIST OF SPECIFIC, WRITTEN PROCEDURES NECESSARY TO ENSURE SANITARY CONDITON IN THE
FOOD PLANT AS SANITATION STANDARD OPERATING PROCEDURES(SSOP). COMPLEMENTARY SOP
CAN ALSO BE PROVIDED
o SSOP WILL INCLUDE WRITTEN STEPS FOR CLEANING AND SANITIZING TO MAKE THE FOOD SAFETY,
LEGAL AND QUALITY PRODUCTS.
o THE CGMP ( A.O. NO 253 S. 24) CAN HELP GUIDE THE PLANT WHEN THE PLANT’S SOPS AND SSOPS
ARE BEING DEVELOPED

NOTE:

SSOP ENFORCED IN PLANT NEEDE FOR LTO APPLICATION

o EQUIPMENT
o GENERAL DAILY CLEANING PROCEDURE FOR FOOD PROCESSING EQUIPMENT

POLICY:
ALL EQUIPMENT, USED FOR PROCESSING OF PINILI PRODUCTS WILL BE CLEANED DAILY AFTER
EACH PRODUCTION AND SANITIZED WHEN APPROPRIATE.

POCEDURE:
 FOOD SAFETY TEAM LEADER OR DESIGNATED EMPLOYEE WILL BE RESPONSIBLE FOR
SOP AND SSOP MONITORING DAILY USING
 DEVIATION/CORRECTIVE ACTION MUST BE RECORDED BY MONITORING EMPLOYEE.
 RECORDS MAINTAINED ON FILE BY THE FOOD SAFETY TEAM LEADER FOR AT LEAST

FOOD PROCESSING EQUIPMENT DAILY CLEANING PROCEDURE SHALL INCLUDE:


 RETRIVAL OF ALL WORK IN PROCESS FOOD MATERIALS
 LOCK OUT PROCEDURES PER EQUIPMENT
 DISASSEMBLY OF APPROPRIATE EQUIPMENT PARTS
 CLEANING/WASHING PROCEDURES
 APPLICATION OF DISINFECTANT
 REASSEMBBLY OF EQUIPMENT
 WASTE MATERIAL TO WASTE DEPOT
NORE FOR SOP AND SSOP FOR DAILY CLEANING OF EQUIPMENT
 THE FOLLLOWING DETAILED WORK INSTRUCTION WITH ACCOMPANYING
CHECKLIST/SCHEDULE

o WORKING AREA
o PERSONNEL
o PEST CONTROL PROGRAM