REPUBLIC OF THE PHILIPPINES. DEPARTMENT OF HEALTH BUREAU OF FOOD AND DRUGS Give Drive, Fllnvest Corporate City ‘Alabang, Muntinlupa Cly 01 February 2007 BUREAU CIRCULAR No. __ 2007-003 To: ALL LOCAL MANUFACTURERS, DISTRIBUTORS/ IMPORTERS/ WHOLESALERS AND OUTLETS OF VACCINES AND OTHER BIOLOGICAL PRODUCTS. Subject: COLD CHAIN MANAGEMENT REQUIREMENTS Pursuant to the provisions of Republic Act No.3720 otherwise known as Food, Drugs, Devices and Cosmetics Act, as amended by Executive Order No. 175, and in line with the objectives of Department of Health Administrative Order Nos. 56 s. 1989, 27 s. 2001 and 47-A s. 2001, the attached requirements are hereby adopted for information, guidance and strict compliance of all concerned. All establishments and outlets applying for a license to manufacture, import, distribute or sell vaccines and other biological products are hereby directed to comply with the said requirements, This compliance will partly determine whether a certain establishment is capable to handle vaceines and biological products and shall be reflected in its License to Operate (LTO). Existing establishments handling vaccines and other biological products are likewise directed to upgrade their Cold Chain Management capabilities as provided for in this issuance. Renewal/revalidation of their LTOs will be partly based on this. For purposes of identification, a phrase “ Capable to handle vaccine and biological products” shall be printed prominently in the LTOs of concerned establishments and shall serve as a major prerequisite once their products are being applied for registration. This circular takes effect immediately. PROF. LETICIA BARBARA B. GUAIERREZ, MS Director IV “Smoking is Dangerous to your Health”COLD CHAIN MANAGEMENT REQUIREMENTS i MANUFACTURERS AND DISTRIBUTORS Facility and Equipment 11 12 1d 14.2 13 1.1.4 1415 1.1.6 1.1.7 1.1.8 1.1.9 Cold room 1.1.1.1 Appropriate and adequate lighting facilities 1.1.1.2 Steel racks and/or shelves/pallets (steel, aluminum or plastic) Walk-in Freezer (for establishment dealing with products requiring -15°C to -25°C only) 1.1.2.1 Appropriate and adequate lighting facilities 1.1.2.2 Steel racks and/or shelves/pallets (steel, aluminum or plastic) Biological or pharmaceutical refrigerator (for establishment with minimal stock of vaccines and biological products only) Ice Pack Freezer Cold Transport Vehicle (for establishment with large volume deliveries only) Cold Box / Transport Box Vaccine Carriers Ice Packs Voltage Stabilizers (Automatic Voltage Regulator) 1.1.10 Generator set Cold Chain Monitoring Tools 1.21 1.2.2 1.2.3 1.2.4 1.2.5 1.2.6 Vaccine Cold Chain Monitors Vaccine Vial Monitors Freeze Watch Indicators Thermometers (minimum of two) 1.2.4.1 Calibration should be at least twice a year ‘Temperature alarm systems Temperature monitoring in cold room and freezer room (any of the following) 1.2.6.1 Pen recorders 2 Digital recording system 3 Manual monitoring chart (should be accomplished by a technical personnel) 1.2.6.3.1 Monitoring and recording should be at least twice a day, seven (7) days a week Personnel 13.1 13.2 13.3 Training records 1.3.1.1 Attendance to any credible training / seminar on cold chain ‘management, as determined by BFAD Duties and responsibilities Protective working clothing accessories (for establishment with cold room and walk-in freezer only) 1.3.3.1 Warm clothing / jackets 1of31.4 1.3.3.2 Trousers 1.3.3.3 Gloves 1.3.3.4 Boots Documentary Requirements 1.4.1 Contingency plan for both mechanical and power failure 1.4.2 Contingency plan in case of cold chain emergency 1.4.3 Standard Operating Procedures (SOPs) on the following: 1.4.3.1 Maintenance and care of the following facility and equipment: 1.4.3.1.1 Cold room 1.4,3.1.2 Walk-in freezer 1.4,3.1.3 Biological or pharmaceutical refrigerator 143.1.4 Chiller 1.4.3.1.5 Ice pack freezer 1.4,3.2 Monitoring and adjusting o f temperature o f the following facility and equipment: 1.43.2.1 Cold room Walk-in freezer Biological or pharmaceutical reftigerator u Chiller 1.4,3.2.5 Ice pack freezer 1.4.3.3 Cold chain procedures employed from the country of origin, port of entry up to the outlets 1.4,3.4 Temperature mapping 1.4.3.5 Freezing of ice packs 1.4.3.6 Maintenance of correct temperature in cold boxes / transport boxes and vaccine carriers including validation studies 1.4.3.7 Stacking of vaccines and biological products in cold room/ walk-in freezer 1.4,3.8 Loading of vaccine into cold boxes /transport boxes and vaceine carriers 1.4,3.9 Product complaint 1.43.10 Product recall 1.43.11 Proper destruction of expired/damaged/recalled vaceines and biological products 1.43.12 Emergency and safety measures in case of breakage or other incident that may arise during handling and storage 1.4.4 Certificate/s of calibration of all temperature monitoring devices 1.4.5 Records of the following: 1.4.5.1 Temperature mapping 1.4.5.2 Validation studies 1.4.5.2.1 Cold chain compliance during transport 1.4.5.2.2 Freezing and thawing time of icepacks 1.4.5.3 Product recall including status and actions taken 1.4.5.4 Product complaint including status and actions taken 20f3RETAIL DRUG OUTLETS ait 22 22) 2.4 Facility and Equipment 2.1.1 Biological or pharmaceutical refrigerator (dedicated for vaccine, biologicals and other drug products requiring cold storage only) 2.1.2 Freezer or domestic refrigerator with freezer (for ice to be used in dispensing) 2.1.3 Generator set Cold Chain Monitoring Tools 2.2.1 Thermometers (minimum of two) 2.2.1.1 Calibration should be at least twice a year 2.2.2. Temperature monitoring record 2.2.2.1 Digital recording system (if applicable) 2.2.2.2 Manual monitoring chart (should be accomplished by the pharmacist or any technical personnel) 2.2.2.2.1 Monitoring and recording should be at least twice a day, seven (7) days a week Personnel 2.3.1. Training records 2.3.1.1 Attendance to any credible training / seminar on cold chain management, as determined by BFAD 2.3.2 Duties and responsibilities Documentary Requirements 2.4.1 Contingency plan for both mechanical and power failure 2.4.2 Contingency plan in case of cold chain emergency 2.4.3 Standard Operating Procedures (SOPs) on the following: 2.4,3.1 Maintenance and care of the biological or pharmaceutical refrigerator / chiller / freezer 2.4.3.2 Monitoring and adjusting of temperature of the biological or pharmaceutical reftigerator / chiller / freezer 2.4.3.3 Cold chain procedures employed in dispensing 2.4.3.4 Stacking of vaccines and biological products in the biological or pharmaceutical reftigerator / chiller 2.4.3.5 Emergency and safety measures in case of breakage or other incident that may arise during handling and storage 2.4.3.6 Product complaint 2.4.3.7 Product recall 2.4.4 Certificate/s of calibration of all thermometers 3 0f3