fepblic of the Phippines Department of Health FOOD AND DRUG ADMINISTRATION Flivest Corporate ty Mi ‘Alabang ty of Muntinlupa 16 May 2014 FDA CIRCULAR No.BOTS*014 SUBJECT: MINIMUM NUMBER OF FOR EACH ‘TEST ANALYSIS MPLE UNITS REQUIRE! For the information and guidance of all concemed, hereunder is the fist of the minimum number of sample units for each test analysis appropriate for the product collected or submitted. This Circular shall supersede Bureau Circular No. 6-A series 2001 for the Revised Minimum Required Samples for Laboratory Analysis. 1. FOOD PRODUCTS a. Microbiological Test Reference: FDA Circular No. 2013-010 Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods NOTE: Multiple tests can be run on a single sample as long as it has a suffici amount for testing. Tests with a specific weight or volume indicated (Campylobacter Cronobacter spp., Listeria monocytogenes and Salmonella) must meet required amount of sample for testing, SAMPLE TYPE TEST/MICROORGANISM | NUMBER OF | | SAMPLE UNITS MILK AND DAIRY PRODUCTS n Milk powders ‘© Salmonella’25 g ] e.g, whole, nonfat or -Normal routine | 10 commercial led milk, buttermilk, presentations with | whey and whey protein | anet weight of not | concentrate Jess than 50 g each | (intended for adults and | | children more than 36 | _—_-High risk population | 30 commercial months of age) | presentations with | | a net weight of not | less than 50 each orms, cfu/ml # Yeast and Molds Count, efumL. | presentations with Standard plate count, cfumL. | # net volume of not less than 25 Limb each 6 commercial presentations with 5 commercial ilk (evaporated |» Commercial Sterility _ ty to drink) and Cream (UHT/sterilized) | | anet volume of | | not less than 10 | Page 1 of 16SAMPLE TYPE TEST/MICROORGANISM | NUMBER OF ____ SAMPLE UNITS Pasteurized Milk © Coliforms, efu/g ‘5 commercial © Salmonellal25 ml. | presentations with © Listeria monocytogenes/25 mL_ | @ net volume of © Psychrotrophic bacteria, not less than 100 efwmL ‘mL each Standard plate count, efwml, > For flavoured milk Pasteurized Cream © Coliforms, efu/g 3 commercial # Salmonella’2s g presentations with © Listeria monocytogenes/25 g | a net weight of not © Psychrotrophic bacteria, cfg | less than 100 g # Standard plate count, cfu/g each Yogurt and other © Staphylococcus aureus 3 commercial fermented mi (coagulase +), cfu/ml presentations with © Coliforms, efivimL. anet volume of © Salmonellal25 mL not less than 50 ike mL each ‘Cheese and cheese © Staphylococcus aureus 5 commercial products (coagulase +), efu/g presentations with e.g, Cottage cheese, soft. | Escherichia coli, MPN/g anet weight of not and semi-soft cheese © Coliforms, MPN/g Jess than 100 g © Psychrotrophic bacteria, cfu/g | cach # Salmonella’2s g # Listeria monocytogenes/25 Processed Cheese © Coliforms, efu/g 3 commercial Spread © Staphylococcus aureus presentations with (coagulase +), cfu/g a net weight of not oll stantiard pts count cfulge Jess than 20 g each All raw milk cheese; raw | © Campylobacter/25 S commercial milk un-ripened cheese |» Salmonellal25 g presentations with ‘Listeria monocytogenesi25 g | anet weight of not © Staphylococcus aureus less than 100 g (coagulase +), cfu/g | each FATS, OILS AND FAT EMULSIONS: Butter (whipped, © Enterococci, cfu/g | S commercial pasteurized) ‘© Molds and yeast count, cfg _| presentations with © Proteolytic bacteria, cfu/g ‘a net weight of not © Coliforms, cfu/g less than 25 g each © Staphylococcus aureus (coagulase +), efu/g © Psychrotrophie bacteria, cfu/g ‘# Standard plate count, cfivg Butter made from * Coliforms, cfu/g 3 commercial unpasteurized milk or | Escherichia coli, MPN/ g presentations with milk products © Staphylococcus aureus a net weight of not (Coagulase +), cfu/g less than 25 g each Page 2 of 16SAMPLE TYPE TEST/MICROORGANISM NUMBER OF | SAMPLE UNITS © Salmonella2s ] ‘Listeria monocytogenesi2S ¢ | Standard plate count, cfw/g i Margarine ‘© Staphylococcus aureus 3 commercial (coagulase +), efu/g presentations with ‘© Faecal coliform, MPN/g a net weight of not ‘© Listeria monocytogenes/25 g less than 75 g each © Salmonella2s Standard plate count, efu/g © Molds and yeast count, cfu/g EDIBLE ICES, INCLUDING SHERBET AND SORBET Ice Cream and Sherbet | + Coliforms, cfu/g 5 commercial (plain and flavoured) * Listeria monocytogenesi2S g | presentations with and © Salmonella25e a net weight of not Ice Cream with added | 6 standard plate count, cfu/g less than 75 g each | ingredients (nuts, fruits, |. Sraphylococcus aureus cocoa, etc.) (coagulase +), cfu/g | Flavored Iee (e.g Ice ‘© Standard plate count, cfu/g 3 commercial candy) * Coliforms, MPN/g presentations with * Molds and yeast count, cfu/g anet weight of not © Salmonella’2s g less than 50 g each ‘CONFECTIONERIES ‘Cocoa Powder, * Molds, efu/g ] 5 commercial Chocolate # Salmonella’2s | presentations with Confectionaries * Coliforms, MPN/g | a net weight of not | (chocolate bars, blocks, | «Standard plate count, cfu/g less than 50 g each bonbons), Sugar Confectionaries (Hard and soft candies, toffees, caramel, fondants, creams, nougats and pastes) and Chocolate | products FRUITS AND VEGETABLES, NUTS AND SEEDS Frozen Vegetables & | © Escherichia coli, MPN/g | 5 commercial ri | presentations with and Dried Vegetables | a net weight of not less than 25 g each Fermented Vegetables, | « Molds and yeast count, cfg | 5 commercial Ready to Eat (¢.g. © Coliforms, MPN/g presentations with Kimehi) * Escherichia Coli, MPN/g. a net weight of not © Salmonella/25 g | less than 50 g each * Staphylococcus aureus, cfg Fruits & Vegetable © Commercial sterility | 6 comme products in | presentations with Hermetically sealed | anet weight of not Page 3 of 16SAMPLE TYPE TEST/MICROORGANISM NUMBER OF SAMPLE UNITS ‘containers (thermally less than 25 g each processed) Coconut (dessicated) © Salmonella’25 * Total plate count, cfu/g $ commercial * Coliform, cfg presentations with © Yeast, cfu/g, a net weight of not © Molds, cfu/g less than 50g each Escherichia coli , MPN/g Peanut Butter & other Nut Butters © Consumed without © Salmonellal25 g 5 commercial heating or other presentations with treatment to destroy a net weight of not microbes, less than 50 g each © Used as ingredient in | © Salmonellal25 g commercial moisture food presentations with a net weight of not ees forge less than 25 g each ‘Sun Dried Fruits * Molds, cfu/g 5S commercial ‘© Osmophilic Yeasts, cfu/g presentations with © Escherichia coli, MPN/g a net weight of not less than 25 g each EGG AND EGG PRODUCTS Pasteurized Egg © Coliforms, cfu/g ] 5 commercial Produets (liquid, frozen | © Salmonella/25 | presentations with or dried) ‘© Molds and yeast count, cfu/g a net weight of not (for dried products) less than 50 g each Standard plate count, cfu/g AND CEREAL PRODUCTS Breakfast Cereals © Molds, cfu/g $ commercial © Yeast & yeast-like fungi, cfu/g | presentations with © Coliform, cfu/g net weight of not + Standard plate count, cfiu/g less than 25 g each Cereals/Cereal Grains | Molds and yeast count, cfu/g | S commercial | * Standard plate count, cfwg presentations with * Coliforms, cfu/g | anet weight of not Escherichia coli, MPN/g | Hess than 25 g each Cultured seeds and ‘© Escherichia coli, MPN/g $ commercial grains © Coliforms, efu/g presentations with (eg. bean sprouts, alfalfa | ¢ Salmonella/25 g a net weight of not etc.) less than 50 g each ‘Soya Flours, ‘© Molds, cfu/g ‘5 commercial Concentrates and * Salmonella25 g presentations with Isolates | a net weight of not | less than 50 g each Page 4 of 16SAMPLE TYPE TEST/MICROORGANISM | NUMBER OF | SAMPLE UNITS Flour, Corn meal, Corn | * Molds, cfw/g | Scommercial grits, Semolina © Yeast & yeast-like fungi, cfw/g | presentations with © Coliforms, cfu/g | anet weight of not © Bacillus subtilis, cfw/g | less than 25 g each “rope spores” | Frozen entrees © Bacillus cereus, cfuig 3 commercial containing Rice or Corn | presentations with | anet weight of not less than 25 g each Soy Protein © Coliforms, cfu/g |S commercial © Escherichia coli, MPN/g | presentations with ‘© Psychrotrophic bacteria, cfu/g 4 net weight of not © Clostridium perfringens, cfulg | !ess than 50 g cach ‘© Molds and yeast count, cfg | © Salmonella 25 g | © Standard plate count, efw/g | Tofu © Bacillus cereus, cfu/g 5 commercial © Escherichia coli, MPN/g presentations with © Staphylococcus aureus a net weight of not (coagulase +), efu/g less than 25 g each Pasta Products and * Coliforms, efu/g 5 commercial Noodles Uncooked (wet, & dry) Molds and yeast, cfu/g ‘Staphylococcus aureus (coagulase +), cfi/g, presentations with a net weight of not less than 50 g each © Salmonella /25 g Standard plate count, cfu/g | Starch ‘© Coliforms, cfu/g 5 commercial | * YMC, cfwg, presentations with © Salmonellal2s g a net weight of not Standard plate count, cfg less than 50 g each BAKERY PRODUCTS Frozen Bakery products | * Staphylococcus aureus 5 commercial (ready to eat) with low- acid or high ay fillings (coagulase +), cfu/g Salmonella/ 25 presentations with | annet weight of not | or toppings less than 50 g each Frozen Bakery Products | « Staphylococcus aureus 5 commercial (to be cooked) with low- acid or high ay fillings (coagulase +), cfu/g Salmonella/ 25 ¢ presentations with a net weight of not or toppings less than 50 g each (c.g. meat pies, pizzas) Frozen and Refrigerated | « Molds, cfu/g 3 commercial Doughs (Chemically leavened) © Yeasts & yeast-like fungi, cfwg Coliforms, cfu/g Psychrotrophic bacteria, cfu/g Standard plate count, cfu/g presentations with net weight of not | tess than 50 g each Page S of 16SAMPLE TYPE TEST/MICROORGANISM NUMBER OF SAMPLE UNITS ‘* Salmonellal 25 g © Staphylococcus aureus (coagulase +), cfu/g Escherichia coli, MPN/g Frozen & Refrigerated | © Molds, cfu/g 5 commercial Doughs © Yeasts & yeast-like fungi, presentations with ofwe a net weight of not © Coliforms, cfw/g less than 25 g each ‘© Psychrotrophic bacteria, cfu/g + Standard plate count, cfu/g Baked Goods ‘© Staphylococcus aureus 5 commercial (microbiologically (coagulase +), cfu/g presentations with sensitive types e.g Mold and yeast count, cfu/g | a net weight of not containing eggs & dairy | » Standard plate count, cfu/g | less than 25 g each Products) © Coliforms, cfwg ns Coated or Filled, Dried | © Coliforms, MPN/g 5 commercial Shelf-Stable Biscuits | ¢ Salmonella/25g presentations with ‘a net weight of not less than 50 g each )Y TO EAT SAVOURIES Ee ‘Snack Foods © Molds, cfu/g 5 commercial © Yeast & yeast-like fungi, efiv/g | presentations with © Coliform, efu/g anet weight of not «Standard plate count/APC, cfiw/g | less than 25 g each SPICES, SOUPS, SAUCES, SALADS AND PROTEIN PRODUCTS Dry Mixes for Soup and Sauces Clostridium perfringens, cfulg 5 commercial * YMC, cfu/g presentations with * Coliforms, cfg a net weight of not ‘* Standard plate count, cfw/g less than 50 g each * Salmonellai2s g Yeast ‘© Salmonella2s 5 commercial presentations with a net weight of not fend less than 50 g each Spices © Molds, cfuig |S commercial Standard plate count, efulg, | presentations with a net weight of not less than 25 g each Spices (ready to eat) Coliforms, cfg © Staphylococcus aureus (coagulase +), cfg 5 commercial presentations with net weight of not less than 50 g each # Salmonella’ 25 g * Molds, cfg Standard plate count, efu/g Salad Dressing, ‘© Standard plate count, cfu/g 5 commercial pHS46 © Molds and yeast, cfg presentations with Page 6 of 16SAMPLE TYPE, TEST/MICROORGANISM | NUMBER OF SAMPLE UNITS (eg. Mayonnaise, + Salmonella’25 g ‘a net weight of not ‘Thousand Island, Ranch, | © Listeria monocytogenesi25 g _| less than 75 g each French) BEVERAGES Non Alcoholic Beverages | Molds and yeast count, efumL. | 5 commercial (e.g. Ready to drink, * Coliforms, cfumL | presentations with softdrinks, iced tea, ‘© Standard plate count, efwmL | @net volume of energy drinks) | not less than 25 | mL each | Frozen Juice Standard plate count, efumL | Scommercial | Concentrate ‘* Molds and yeast, efu/mL presentations with anet volume of not less than 25 mL each Powdered Beverages | + Standard plate count, cfu/g 5 commercial (e.g. iced tea, powdered | » Coliforms, efw/g presentations with Juices/mixes) a net weight of not __| ess than 25 g each Bottled water ‘© Heterotrophie Plate Count, 5 commercial efwmL, | presentations with Coliform (must not be | anet volume of Escherichia coli), MPNimL | not less than 350 '* Pseudomonas aeruginosal109 | mL each mL Faecal Streptococci! 100 mL. FOOD FOR INFANTS AND YOUNG CHILDREN Powdered Infant ‘* Cronobacter spp. / 10 g Formul * Salmonella /25 g 60 commercial * E.coli, MPN/g (for complaint _| presentations with samples) | anet weight of not less than 75 g each Follow-up © Salmonella 725 g Formula/Milk ‘© Coliforms, MPN/g (for 60 commercial ‘Supplement complaint samples) presentations with ‘© Escherichia coli, MPN/g (for | @ net weight of not complaint samples) less than 75 g each Infant Formula - liquid | + Commercial Sterility 6 commer (UHT/sterilized) and presentations wit Baby foods in a net weight of not hermetically sealed less than 25 g each containers Dried and Instant * Coliforms, MPN/g 60 commercial products requiring © Standard plate count, cfu/g presentations with reconstitution # Salmonella 25 g a net weight of not @ Listeria monocylogenes/25 gq _| less than 75 g each Dried products ‘© Coliforms, cfu/g |S commercial requiring reconstitution | © Salmonella’2S ¢ __| presentations with Page 7 of 16SAMPLE TYPE TEST/MICROORGANISM NUMBER OF SAMPLE UNITS ‘and boiling before Standard plate count, cfu/g ‘a net weight of not consumption [ess than 50 g each Cereal based foods for | © Bacillus cereus, cfwg | a a infants © Clostridium perfringens, cfulg | peconations with * Standard plate count, cfwg | Les alah et est Sanaa bae a | tess than $0 g each * Coliforms, MPN/g_ FISH AND FISH PRODUCTS Fresh Frozen Fish and Cold-Smoked Escherichia coli, MPN/g, Staphylococcus aureus (coagulase +), efu/g 5 commercial presentations with a net weight of not less than 50 g each | * Vibrio parahaemolyticus, cfu/g © Salmonella’2s ¢ Standard plate count, cfu/g Pre-Cooked Breaded | © Escherichia coli, MPN/g 3 commercial Fish © Staphylococcus aureus presentations with (coagulase +), cfu/g a net weight of not * Standard plate count, cfu/g less than 25 g each Frozen Raw ‘© Escherichia coli, MPN/g ‘5 commercial Crustaceans © Staphylococcus aureus presentations with (coagulase +), cfu/g a net weight of not © Salmonella [25 g | less than $0 g each © Vibrio parahaemolyticus, cfu/g | Standard plate count, cfu/g. Frozen Cooked © Escherichia coli, MPN/g 20 commercial Crustaceans © Staphylococcus aureus presentations with (coagulase +), efu/g Salmonella (25 3 Vibrio parahaemolyticus, cfu/g Standard plate count, cfu/g a net weight of not less than 50 g each ‘Cooked, Chilled & Frozen Crabmeat Escherichia coli, MPN/g Staphylococcus aureus (Coagulase +), cfu/g Vibrio parahaemolyticus, cfw/g Standard plate count, cfu/g | 10 commercial a net weight of not less than 50 g each Fresh & Frozen Bivalve Molluscs Escherichia coli, MPN/g Salmonella’25 g Vibrio parahaemolyticus, cfg Standard plate count, cfi/g 20 commercial presenti ‘a net weight of not | tess than $0 g each Fish & Shellfish products in hermetically sealed containers (thermally processed) Sterility | presentations with ‘anet weight of not Jess than 25 g each Page 8 of 16b. Physico-chemical Tests : NUMBER OF SAMPLE TYPE, TEST PARAMETER SNe Milk and Dairy ‘+ Melamine Products ‘* Mycotoxin(Aflatoxin M;) (milk powder, cream ‘© Vitamins and Minerals powder, liquid milk, © Proximate Analysis/pH cheese and cheese te products) Fats and Oils, and Fat | Vitamin A Emulsions * Fat (butter, margarine, vegetable oils and fats) '* Sodium Benzoate Fruits and Vegetables, Nuts and Seeds (fruits in hermetically container, dried fruits, * Colorants * Sodium Cyclamate/A spartame Potassium Sorbate) | | For each test © Preservative (Sodium Benzoate, | parameter: | 2-5 commercial jams, jellies, marmalades, |ieeaeneea titi pulp, purees) | total average Ready-to-eat savouries | © Vitamin A/lron intatinam) (snack foods) © Proximate Analysis weight/volume of ‘© Mycotoxin(Aflatoxin) 250 (mL or grams) ‘Sodium Chloride Processed Fish and © Heavy Metals Products ‘© Sodium Chloride (smoked, dried, canned, | 6 Proximate Analysis salted) © Histamine + Total Sugar (refined and raw sugars, | brown sugars, honey) FOOD SUPPLEMENT Tablet and eapsule © Heavy Metals ] 250 tablets/capsule © Vitamins and Minerals, 50 tablets/eapsule Granules/ powder for | + Heavy Metals For each test ‘suspension/ syrup * Vitamins and Minerals parameter: © 10- 15mL. 25 bottles *30mL | 10 bottles © 60-120 mL 6 bottles ‘SPICES, HERBS, SOUPS, SAUCES, SALADS, VINEGARS, SEASONINGS AND CONDIMENTS Spices ‘© Colorants For each test Salad dressings © Fat parameter: Page 9 of 16NUMBER OF SAMPLE TYPE, TEST PARAMETER MEETINGS Ketchup * Colorants 2-5 commereis Vitamin A | presentation with Fish sauce ® Sodium Chloride total average © Proximate analysis minimum Histamine weight/volume of | Soy sauce/seasoning © 3-MCPD | 250 (ml. grams) Sodium Chloride | ‘Salt * Lodine content | * Sodium Chloride Vinegar * Total acidity ‘BEVERAGES ‘Alcoholic Beverages * Alcohol content (beer and malt beverages, | pH wine) Non-alcoholic Beverages (canned/bottled fruit/vegetables juices, powdered beverages, Vitamins and Minerals * Sodium Cyclamate/Aspartame Preservative (Sodium Benzoate, Potassium Sorbate) For each test parameter: 2-5 commercial presentation with total average energy drinks and * DEHP minimum concentrates) © Caffeine weightvolume of Coffee and Tea * Caffeine ee ‘© Mycotoxin (Ochratoxin) Heavy Metals Bottled Water ‘© Physical Test (Color, Taste, 3 bottles of 300mL. Odor, Turbidity) forall test * pH parameters # Total Dissolved Solids | * Conductivity | + Aluminum « Free Cyanide © Nitrates # Heavy Metals (Lead, Cadmium) ‘AND CEREAL PRODUCTS Cereal/cereal grains, ‘© Vitamin A/Iron/Potassium | flour, corn/cor meal, Bromate grits, starch, oats ‘© Mycotoxin(A flatoxin) For.each test © Gliadin pereinciatel Pasta products «Vitamin Aron Sees (*fortified) # Mycotoxin(A flatoxin) vale Noodles * *Vitamin A/Iron ane (*fortified) ‘© Mycotoxin(Aflatoxin) weight/volume of + Benzopyrene 250 (mL or grams) Starch-based products ‘® Maleic Acid (tapioca) Page 10 of 165 NUMBER OF | SAMPLE TYPE, TESTPARAMETER | AMPLE UNITS | BAKERY PRODUCTS Bread © *Vitamin A For cach taf ] (*fortified) © Colorants parameter: | fed: + Fi 2-S commercial | Crackers © Borax presentation with | * Colorants total average | Cookies & Milk based | *VitaminA minimum Products © Melamine weight/volume of (fortified) 250 (mL or grams) Il, PHARMACEUTICAL PRODUCTS, a, Microbiological Tests for Botanical Ingredients and Products NUMBER OF ~ SAMPLE TYPE, TEST PARAMETER SAMPLE UNITS Dried or Powdered | Botanicals Total Aerobic Microbial count Total Combined Yeast & Mold Count Bile-tolerant Gram-negative Bacteria Absence of Salmonella spp. & Escherichia coli in 10 g Powdered Botanical ‘* Total Aerobic Microbial count | 2 commercial Extracts ‘* Total Combined Yeast & presentations with Mold Count anet weight or ‘© Absence of Salmonella spp. & | volume of not less | Escherichia coli in 10g __| than 50 g or mL. Tinctures/ Fluid Extracts/ | ¢ Total Aerobic Microbial count | for each sample Infusions/Decoctions * Total Combined Yeast & Mold Count Nutritional Supplements Microbial count with Botanicals and * Total Combined Yeast & Botanicals to be treated Mold Count with boiling water before | » Absence of Salmonella spp. & use Escherichia coli in 0g ‘OTHER HERBAL PRODUCTS Solid/Liquid Products ‘© Aerobic bacteria, cfw/g 2 commercial ‘© Yeast and moulds, efu/g, presentations with Escherichia coli a net weight or © Salmonella volume of not less * Staphylococcus aureus than 50 g or mL © Other Enterobacteria, MPN/g_| for each sample NON-STERILE PRODUCTS "Nonaqueous/ aqueous ‘ Total Aerobic Microbial count | Minimum of 2 preparations for oral use _| Total Combined Yeast & commercial Page 11 of 16Mold Count © Absence of Escherichia coli in 1 gormL Reetal use © Total Aerobic Microbial count * Total Combined Yeast & Mold Count ‘Oromucosal/ Gingival’ | Total Aerobic Microbial count Cutaneous/ Nasal/ ‘* Total Combined Yeast & Auricular use Mold Count Absence of Staphylococcus aureus in 1 g or mL. ‘# Absence of Pseudomonas aeruginosa in 1 gor mL. ‘Vaginal use © Total Aerobie Microbial count * Total Combined Yeast & Mold Count Absence of Staphylococcus aureus in 1g or mL, ‘* Absence of Pseudomonas aeruginosa in 1 g or mL. ‘¢ Absence of Candida albicans in 1 gor mL. ‘Transdermal patches * Total Aerobie Microbial count (limits for one patch * Total Combined Yeast & including adhesive layer Mold Count and backing) © Absence of Staphylococcus aureus in | patch ‘* Absence of Pseudomonas ‘aeruginosa in 1 patch Inhalation use (special | « Total Aerobic Microbial count requirements apply to © Total Combined Yeast & liquid preparations for Mold Count nebulization) © Absence of Staphylococcus aureus in | g or mL, '* Absence of Pseudomonas aeruginosa in 1 g or mL # Absence of bile-tolerant | Gram-negative bacteria in 1 g or mL presentations with a total net weight or volume of not less than 50 g or mL PRODUCTS WITH OFFICIAL MONOGRAPHS, Refer to the latest issue/version of the US Pharmacopeia Minimum of 2 commercial presentations with a total net weight or volume of not less than 50g or mL Page 12 of 16b. Biological Tests SAMPLE TYPE TEST PARAMETER NUMBER OF SAMPLE UNITS Liquid Preparations a. ImL to 100mL * Bacterial endotoxins test 20 bottles 'b, more than 100mL. 6 bottles a, ImL to 100mL. ‘Sterility Test 20 bottles bb. 500mL to 100ml. 6 bottles _ Solid Preparations + Sterility Test 20 units c. Physico-chemical Tests | NUMBER OF SAMPLE TYPE TEST PARAMETER PaCS Tablet/Capsule * Assay/Potency 60 tablets/capsules © Dissol 50 tablets/capsules ‘© Uniformity of Dosage Units | 40 tablets/capsules ‘* Identification Test 20 tablets/capsules * Disintegration 20 tablets/eapsules Tablet Hardness 30 tablets/eapsules Granules/ Powder for | Assay and Minimum Fill | 10 bottles Suspension/ Syrup * pH 2 bottles Identification Test 3 bottles Injectables © Assay/Potency 20 vials/ampules mL to 2mL) + pH 10 vials/ampules Injectables 20 vials/ampules (SmL. to 10mL) 5 vials/ampules Injectables 110 vials/ampules 20mL to 100mL) 2 vials/ampules Ointment/ Cream/Gel__|* Assay/Potency 10 tubes ‘Aerosol 10 pressurised cans ‘Suppositories 30 pieces \CEUTICAL CONTAINERS ‘* Nonvolatile residue Residue on Ignition Plastic container for | « Lead suspension/syrup, oral | 6 Buffering Capacity preparation a. 10 mL 120 pes b. 30 to 60 mL 60 pes ©. 60 to 100 mL 40 pes 4.250 mL 20 pes e500 to 1000 mL 10pes | Plastic bottles/IV infusion a. 100 mL 15 pes Page 13 of 16Mm. Iv. NUMBER OF SAMPLE TYPE, TEST PARAMETER AMPLE UNITS 250 mL 10 pes . $00 to 1000 mL. 6 pes Polyampules 300 pes a. 1to2mL 230 pes b.3toSmL 200 pes ¢.6 to 10 mL Vials | a. 10 mL 120 pes b.20t0 25 mL 60 pes ©. 30 to 50 mL. 30 pes ‘Caps a. Diameter < 0.5 em 800 pes b. Diameter between 1 & 48 pes 2.5cm | c. Diameter > 2.5 em “ 30pes _| DEVICES 5 ‘* Bacterial endotoxins test 20 units Medical Devices © Sterility Test 20unis—_| COSMETIC AND OTHER PRODUCTS. . Microbiological Test NUMBER OF SAMPLE TYPE ‘TEST PARAMETER AU MAETETONETS © Total Aerobic Mrobial Count | 2 commercial Total Yeast & Mold Count | products with not | Any cosmetic sample ‘© Pseudomonas aeruginosa | Tess than 30 g (or | © Staphylococcus aureus mL) net weight for | © Candida albicans each sample Physico-chemical Tests | NUMBER OF SAMPLE TYPE, ‘TEST PARAMETER SAMPLE UNITS ‘Creams, emulsions, © Mercury 3g lotions gels and oils for | * Lead, Cadmium, Arsenic 10g ‘the skin (hands, feet, etc.) | ¢ Hydroquinone 20 g (ormL) © Preservative 20 g (or mL) «Tretinoin 20g (ecmt) Tinted bases (liquids, ‘© Preservative 15 g (or mL) | pastes, powders) 3 Make-up powders, © Preservative 15 g (ormL) after-bath powders, © Lead 10g hygienic powders, ete. a Perfume, toilet waters | ¢ Alcohol 10 mL Page 14 of 16NUMBER OF (or equivalent area) SAMPLE TYPE TEST PARAMETER |g AMpLE UNITS and eau de cologne Toilet soaps, ete. ‘© Sodium hydroxide | 208 Products for making-up | + Preservative 15g (ormL) the face and the eyes © Lead log Products # Colorants Sg 50 mL © Lead log Products for care of the |» Formaldehyde 10 g (or mL) teeth and the mouth * Diethylene glycol 10 g (or mL) a «Fluoride content ns 10 g (or mL) Products for nail eare | * Formaldehyde 10 g (ormL) and make-up Lead log Products for extern: © Preservative | 50g (ormLy intimate hygiene | HAIR CARE PRODUCTS Hair tints and bleaches | Lead 10g | ¢ Hydrogen peroxide 20 mL Products for waving, | ¢ Sodium hydroxide 2g straightening and fixing | ¢ Formaldehyde | 10g(ormL) Cleansing products * Formaldehyde 10 g (or mL) (shampoos) TOYS (Quantity pertains to ‘of the same color which came from same batch/lot) Polymeric Heavy metal (Pb, Cd, Hg) a.9inx Sin 2 pes (or equivalent area) | b.Sinx3in 5 pes (or equivalent area) ¢.3inx2in 10 pes (or equivalent area) | d.1inx 1 in 20 pes (Quantity pertains to | ART MATERIAL/SCHOOL SUPPLIES jes of the same color which came from same batch/lot) Coated metal pencil ease ‘Textile/fabric pencil case Pencil Colored pencil a. Regular size b. Small size Pencil/crayon eraser | Oil Pastel Crayons Heavy metals (Pb, Cd, Hg) S pes “4 pes 20 pes 10 pes 25 pes 3 pes Page 15 of 16SAMPL TYPE a. Jumbo size Modell Color glue/ Glue a. Less than 5 mL. b. S mL and above ling clay | b. Regular size Glitter powder a. Less than 3g b. Above 3g oe Poster color a. Less than 3 mL b. More than 3 mL_ Fabric Paint/ | Paint | a. Less than 5 mL b. More than $ mL. in palette) Water color (in tube or Chalk ‘TEST PARAMETER (Quantity pertains to Soe came from same batch/lot) F | | _NUMBEI ol UNITS | | 3s | 2 pes 10 pes 5 pes/color Spesiec Plastic drinking bottle with cover or cap a. with capacity of 200 mL and above b. with capacity of less than 200 mL Feeding bottle a. with capacity of 200 mL and above b. with capacity of less than 200 mL. | Teat and teether spoon/fork ‘© Migration and Material Test 30 pesicolor 50 pesieolor 0 pes Page 16 of 16