The document discusses Good Manufacturing Practices (GMP) and contamination prevention. It covers types of contamination, sources, and how to prevent them through practices like personal hygiene, sanitation, cleaning, and equipment maintenance. GMP regulations require facilities, equipment, personnel training, and documentation to help assure product quality and safety.

2. WHY DO WE NEED GMP? BAKIT KAILANGAN ANG GMP?

5. SOURCES OF CONTAMINATION AIR , WATER, SURFACES,PEOPLE,PESTS

9. CROSS - CONTAMINATION … BUT IT WAS ONLY A FEW OUNCES … a few ounces? THE WHOLE BATCH IS CONTAMINATED

11. TO COMPLY WITH GMP … Establishment provides Sufficient Space Physical Separation Adequate Lighting Adequate Ventilation Equipment, utensils Adequate facilities for every operations

12. WORKERS AND EMPLOYEES Take necessary steps and follow procedures to assure sanitary and safe operation of the plant.

13. HYGIENE AND SANITATION WHY IS HYGIENE AND SANITATION IMPORTANT? Man is a natural carrier of microorganisms. These are expelled when we SNEEZE (BUMAHIN ) COUGH (UMUBO) YAWN (HUMIKAB ) TALK (NAGSALITA )

14. MICROORGANISMS ARE IN MAN’S HAIR, SKIN, INTESTINES, URINE, UNDERNEATH FINGERNAILS. We collect more microorganisms as we travel from home to our destination due to dust, smoke generated by vehicles and contact with dirty items. It is therefore important that we observe good hygiene and sanitation to avoid contamination of products we handle.

15. PLANT UNIFORM Cover street clothes that contain contaminants, organisms you collect on your way to the plant. Cover your exposed skin which sheds particles with germs.

16. Cover the nose and mouth which are natural reservoir of germs. Trap particles or droplets from the nose and mouth. Cover your hair which have dust & germs. Prevent hair from falling into the product.

17. Cover finger nails and hands which have germs. Street shoes contain germs from the soil and dirt we stepped on, so it must not be worn inside the plant, plant shoes must be used instead.

18. WHY USE RUBBER GLOVES??? It prevents microorganism transfer from our hands to the product we handle. It prevents transfer of product dust to our hands.

19. It is porous and will not prevent transfer of microorganisms and perspiration to the product we handle. It permits transfer of product dust to our hands. WHY CAN’T WE USE COTTON GLOVES???

21. 3) Change gloves for every product change. 4) Torn gloves or those with holes should not be used

24. HOW TO WASH YOUR HANDS

36. BACTERIA Bacilli Bacterial Spores Molds Pneumococci Yeast

39. BFAD IS RESPONSIBLE FOR SEEING THAT OUR COMPANY COMPLIES WITH CGMP REGULATIONS.

40. IF WE HAVE NOT FOLLOWED CGMP REGULATIONS BFAD HAS THE AUTHORITY TO RECOMMEND RECALL

41. HOW WE PURCHASE AND STORE RAW MATERIALS OUR BUILDING LABELLING & PACKAGING THE PRODUCTION & DISTRIBUTION OF OUR PRODUCTS OUR RECORDS OUR EQUIPMENT C G M P

45. GMP REGULATION -Light all Areas -Adequate for our needs -With back-up LIGHTING

59. PATTERN OF LEARNING AND REMEMBERING 83% by vision 50% of what we have heard and seen 11% by smelling 30% of what we have seen 3,5% by smell 20% of what we have heard 1,5% by skin senses 1% of what we read 1% by taste What we Remember What we learn

65. UNDERSTAND THE REQUIREMENTS And demands of your job. Determine how you can do your job most efficiently.

77. MUST KNOW MUST DO EDUCATION TRAINING

78. Y O U R J O B MUST DO MUST KNOW KNOWLEDGE SKILLS

83. EQUIPMENT USED EXCLUSIVELY BY A PRODUCT, INDIVIDUAL LOG IS NOT REQUIRED. ALL EQUIPMENT MUST BE SANITIZED AFTER CLEANING. ALL EQUIPMENT MUST BE VALIDATED. EQUIPMENT MUST NOT BE USED AS STORAGE OF THINGS THAT DON’T BELONG TO THEM.

86. ALL PIPE WORK MUST BE SLOPED SO THAT THEY WILL DRAIN AND TO AVOID LOW SPOT AND DEAD LEGS. INTERNAL WELDS MUST BE SMOOTH, NOT PITTED TO AVOID FLUX-CONTAMINATION. DUST EXTRACTORS MUST NOT LODGE POWDER IN THE DUCTING WHICH MAY FALL BACK INTO THE PRODUCT. DEFECTIVE EQUIPMENT SHOULD BE REMOVED IN THE PRODUCTION AREA, QC, ETC. AND CLEARLY LABELED AS DEFECTIVE.

99. SEQUENTIAL LOG NAME OF MACHINE: TAG NO: CAPACITY: 1-27-09 1-26-09 MFG. ALCOMFORADO B#1 1-26-09 1-26-09 1-25-09 VALIDATION OF NEW MIXTURE 1-25-09 1-24-09 1-24-09 CLEANING 1-24-09 1-23-09 1-20-09 MIXER REPAIR 1-20-09 1-19-09 1-19-09 MFG. RHEA ALCOLOGNE B#5 1-19-09 1-18-09 1-18-09 CLEANING 1-18-09 1-17-09 1-16-09 MFG. RHEA ALC. BATCH 1234 1-16-09 SIGNATURE DATE FINISHED DATE STARTED ACTIVITY DATE

102. MAINTENANCE RECORD NAME OF EQUIPMENT: TAG NO. DATE INSTALLED: SUPPLIER: A . MONTHLY MAINTENANCE B. QUARTERLY MAINTENANCE NOT DONE REASON DONE APR. MAR. FEB. JAN. SERVICE NOT DONE REASON DONE FOURTH Q. THIRD Q. SECOND Q. FIRST Q. SERVICE

103. YEARLY MAINTENANCE RECORD NAME OF EQUIPMENT: TAG NO. DATE INSTALLED : SUPPLIER: NOT DONE REASON DONE 2009 2008 2007 2006 SERVICES

117. COMPONENTS MUST BE PROTECTED FROM HARMFUL BACTERIA

147. Manufacturing Monograph Control Monograph Batch Record SOP’s … They tell us what and how to produce our products

158. To minimize possibility of bringing in Wear protective clothing such gloves, gown, cap, mask… … foreign materials in the production area. For our safety health.

164. I’M NOT MEAN… IM JUST TOUGH! Samples to be tested Q U A L I T Y C O N T R O L

171. ALL CONTAINERS MUST PROVIDE PROTECTION FROM EXTERNAL CONTAMINATION It’s no use!!! Everything is tightly sealed!!

172. CONTAINERS ARE CONTAMINATED BY IMPROPER CLEANING WE MUST HAVE SOP ON CLEANING CONTAINERS CONTAMINATE!!

173. ALL CONTAINERS MUST BE STORED SAFELY ………………. …………… .TO PREVENT DAMAGE AND CONTAMINATION

174. IF CONTAINERS ARE NOT STURDY, AND IF THE COVERS OR LIDS DO NOT CLOSE TIGHTLY…. IT COULD CAUSE DETERIORATION… WHICH COULD REDUCE THE STRENGTH OF THE PRODUCT!!!