Methods to Address

GMP Clause Requirement Objective Evidence/s

Requirement
6.1 Maintenance and Cleaning • Develop procedures for the general • Maintenance Plan for
6.2 Cleaning Programmes maintenance of facilities (building, Facilities and Equipment
6.3 Pest Control Systems equipment and premises) • Maintenance Checklists for
6.4 Waste Management • Establish cleaning frequency and
3.4 Cleaning Maintenance and Personnel Hygiene facilities and equipment
assign (cleaning program)
at Primary Production • Preventive Maintenance
• Develop procedure/guidelines on
4.1 Location waste management procedures
4.2 Premises and Rooms • Develop cleaning methods and • Guidelines/Waste
4.3 Equipment procedures for different areas and Management Plan
4.4 Facilities facilities • Pest Control Plan
7.5 Visitors
8.0 Transportation • Establish equipment and facilities • Procedure on Equipment
qualification procedure or Qualification
guidelines to ensure that • Flood Control
equipment, utensils and other
facilities connected in food • Cleaning Program (cleaning
production are appropriately procedures and methods)
designed and installed • Plant/Building Lay-out
• Develop a Master Plan of the • Programmes on:
facility, defining the specific o construction and lay-out of
location for different areas of buildings
operation o waste and sewage
disposal
o cleaning of equipment

3.0 Primary Production • Develop and implement PRPs,
5.0 Control of Food Hazards operational PRPs and HACCP
plan.
• Compile needed documents to
control raw materials, ingredients
and product-contact materials
(packaging, water
• Document important characteristics
of the end product
• Conduct a hazard analysis and
assessment
• Establish documented procedures
and guidelines in receiving of
incoming materials, inspecting,
packaging, transporting and storing
of food items
• Developed PRPs, operational
PRPs, and HACCP plan.
• Guidelines on storage and
transportation of products
• prevention of cross contamination
• Raw materials, ingredients and
end-product descriptions (e.g.
MSDS, Certification of Analysis,
product information)
• Process flow diagrams
• Register of identified hazards
• Receiving, Storage and Issuance
procedure
• Incoming Inspection procedure
(for Raw Materials especially)
• Work Instructions for sanitary
 • Identify critical control points handling and storing of food items
(CCPs) and equipments and utensils
• Determine critical limits for the • Purchasing/Subcontracting
CCPs, and develop control procedure
measures and planned corrections • Laboratory controls
and corrective actions when critical • Calibration Plan
limits are exceeded • Document and Records Control
• Appointment of food safety team Procedures
members
• Establish a procedure on how to
control documents and records
• Establish periodic sanitary
inspection/audit
9.0 Product Information and Consumer Awareness • Establish procedures in handling • Procedure on Control of
5.8 Recall Procedures customer complaints/feedback Nonconformity
regarding food products • Procedure on Disposition and
• Establish traceability of raw Product Withdrawal
materials, packaging materials, • Procedure on Handling Customer
processing data and lab results Feedback and Complaints
• Establish a written procedure, work • Lot/Batch #/Packaging Guidelines
instruction or guideline that defines
circumstances for recall to be
considered.
• Establish procedures/guidelines for
packaging, to include labeling and
assigning batch or lot no.

10.0 Training, Awareness and Responsibilities • Establish the responsibility and • Job Description
7.0 Personal Hygiene authority of personnel working for • Organizational Structure
5.6 Management and Supervision the organization • Hiring & Recruitment procedure
• Develop procedures on hiring & • Training procedure
recruitment, identification of training • Training Needs Analysis
needs, and repair & maintenance of • Training Program
equipment and facilities.
• Policies and on Hygiene of
• Establish a method on how to personnel
identify training needs
• Internal and External
• Develop and define policy and Communication procedures
guidelines related to
• Develop internal communication
procedure with relation to factors
affecting hygiene
Note: All Procedures, Guidelines, Work Instructions, Policies must be documented