BFAD Memorandum Circular No. 20 (1994)

(NAR) VOL. 6 NO. 2 / APRIL - JUNE 1995

[ BFAD MEMORANDUM CIRCULAR NO. 20, S. 1994, September 07, 1994 ]

MINIMUM REQUIRED SAMPLES FOR LABORATORY ANALYSIS

For the information and guidance of all concerned, hereunder is the list of the minimum required samples for laboratory analysis.

1. Pharmaceutical Products (Applicable only for product registration and deliveries) 1.1 Physico-Chemical Analysis (including Microbiological Test) 1.1.1 Tablet/Capsule - 1 commercial presentation-100 tablets or capsules 1.1.2 - 60 ml - 10 bottles Liquid/Suspension Solution - 120 ml - 6 bottles 1.1.3 Ointment/Cream - less than 5 gm. - 6 tubes/bots. - 5 to 10 gm. - 3 tubes/bots. - 3.5 gm or 15 gm- tubes/bots. - 15 to 30 gm. - 1 tube/bots. 1.1.4 Granule for - 30 mL - 10 bottles Suspension 60 mL - 6 bottles 1.1.5 Powder/Bulk - 500 g Material 1.1.6 Aerosol - 3 commercial presentations 1.1.7 Suppositories - 25 pcs. 1.1.8 Injectables - less than 2 mL - 12 ampules - 5 mL to 10 mL - 3 vials - 20 mL to 100 mL - 1 vial 1.2 Sterility Test1.2.1 Liquid Preparations: 1 mL or less - 15 vials or ampules 2 mL - 5 mL - 12 vials or ampules 10 mL - 20 mL - 10 vials or ampules 25 mL - 50 mL - 6 bottles 100 mL - 1000 mL - 6 bottles 1.2.2 Solid Preparation: Less than 50 mg - 18 vials 50 mg or more but less than 200 mg - 14 vials 200 mg or more - 12 vials Ointments - 12 pcs. 1.2.3 Medical Devices (including leachability test) Sutures - 16 pcs. Surgical Blades - 16 pcs. Needles - 17 pcs. I.V. Catheters - 19 pcs. Scalp Vein - 19 pcs. Sets/Butterfly Transfusion Sets - 11 pcs. Infusion Sets - 11 pcs. Syringes 10 mL-50 - 19 pcs. mL 5 mL-5 mL - 27 pcs. Oxygen Cannula - 10 pcs. Stomach Tube - 10 pcs. Foley Ballon Catheter - 10 pcs. Gloves - 11 packs Contact Lens & - 4 pcs. * Implant Gauze & Surgical - 8 pcs. * Dressings Dialyzing - 9 pcs. device/tubings Drainage Tubings - 10 pcs. Endotracheal Tube - 10 pcs. Feeding Tube - 11 pcs. Oxygen Catheter - 10 pcs. Oxygen Mask - 10 pcs. Peritoneal DialysisAdministration Set - 11 pcs. Rectal Catheter - 10 pcs. Rectal Tubes - 10 pcs. Duodenal Tubes - 10 pcs. Urine Collecting Bag - 8 pcs. Suction Catheter - 8 pcs. * Sterility test only 1.3 Leachability Test 1.3.2 Containers for Pharmaceutical Preparations Plabottles/IV Infusion bags - 4 pcs. Polyampoules - 12 pcs. Ophthalmic containers - 12 pcs. Vials - 12 pcs. Nebulizer/Rotahalers/Diskhalers - 2 pcs. Plastic Containers for Suspension/Syrups 10 mL - 8 pcs. 30-60 mL - 6 pcs. greater than 60mL - 4 pcs. 1.4 Pyrogen Test 1.4.1 Solution for correcting water, electrolytes, acid base and caloric disturbances: ex: parenterals, electrolytes or IV additive solutions, etc. Volume of Product Amount to be Submitted 5 mL 48 pcs. 10 mL 24 pcs. 50 mL 5 pcs. 100 mL 4 pcs. 250 mL 2 pcs. 500 mL 2 pcs. 1000 mL 2 pcs. 1.4.2 Liquid preparations e.g. antibiotics, antineoplastics, vitamins, sedatives, tranquilizers, dissociative agents, anesthetics, analgesics, etc. 1 mL or less 15 vials or ampules 2 mL to 5 mL 10 vials or ampules 10 mL or more 5 vials or ampules 1.4.3 Sterile powder for injection to be reconstitutedLess than 50 mg 10 vials or ampules 50 mg or more but less than 200 8 vials or ampules mg 200 mg or more 5 vials or ampules 1.5 Primary Skin Irritation Test 2 pcs. commercial presentation 1.6 Muscle Irritation Test (I.M. 3 pcs. - do - Adm. Drug) 1.7 Implantation Test 3 pcs. - do - 1.8 Primary Eye Irritation Test 2 pcs. - do - 1.9. Insulin Assay 3 pcs. - do - 1.10 Hemolytic Test 3 pcs. - do - 1.11 Micronucleus Test 3 pcs. - do - 1.12 Safety Test 3 pcs. - do - 1.13 Histamine Test 3 pcs. - do - 1.14 Skin Sensitization Test 3 pcs. - do - 1.15 Iron Dextran Injection Test 3 pcs. - do - 1.16 Other Biological Test - Refer to Animal House Section LSD 2. Food/Food Products 2.1 Physio-Chemical Analysis (Including Microbiological Test [whenever applicable]) Alcoholic Beverages 750 mL - 1 Baking Powder 350 g - 2 Bagoong (Shrimp & Fish) 370 g - 3 Sauce/Catsup 370 g - 3 Barquillos 350 g - 2 Beer 320 mL - 3 Biscuits, Cookies, Snack Foods 2 packs of not less than 250 g per pack Bread - do - Canned Fish (Sardines, Mackerel, 6 cans x 155 g or 4 cans x 370 g Tuna)Canned and Frozen Foods 2 packs of not less than 250 g per pack Candy/Confectionary Products 2 x 250 g Cheese, Butter, Margarine 2 x 370 g Chocolate/Cacao Products 2 x 350 g Corned Beef, Meat Loaf 2 x 370 g Dried Fruits 2 x 500 g Fats and Oils 2 container of not less than 250 mL per container Flavor, Essences, Food Color 2 x 200 mL Flour, Bake mixes 2 x 500 g Fish sauce, Soy sauce, Vinegar 2 x 750 mL Food Supplement (Tablet, Capsule) 50 pcs. (1 bot. in original pack with at least 50 pcs) Fruit juices & Beverages 4 packs of not less than 200 mL/g per pack Frozen meat, Ham, Bacon, Sausages, 2 packs of not less than 250 g per pack etc. Fruit preserves 4 x 340 g Ice cream 2 x half gallon Instant soup/noodles 10 x 85 g Milk powder/Infant formula 2 samples of not less than 250 evaporated, condensed g/sample Oats/Cereals 2 x 500 g Spices/seasoning 4 x 100 g Nut & nut products 2 x 500 g Noodles, pasta, Macaroni 2 x 350 g Pickles 2 x 250 g Tea 2 x 250 g Ready to mix dessert 10 x 85 g Coffee 2 x 200 g Mineral/Bottled Water 5 x 750 mL Cereal-based chips, curls, Pretzels 2 x 250 g Nutritive Sweeteners 2 x 250 g Non-Nutritive Sweeteners 2 x 100 g Food Dressings and Spreads 2 x 500 g Note: pack means in original commercial pack 3. Cosmetics Products 3.1 Physico-Chemical Analysis 3.1.1 Skin Care Products Deodorants/antiperspirant 100 mLFeminine Deodorant 100 mL Lotions/Moisturizers 100 mL Cleansing creams/Lotions 100 mL Astringents 200 mL Depilatories 100 mL/g Skin Lighteners 100 mL Skin fresheners 100 mL Foot powder 100 g Suntan/Sunscreen 100 mL/g Shaving cream 100 mL 3.1.2 Hair Care Products 3.1.2.1 Noncoloring Hair Conditioners/Rinses 200 mL Hair Spray 100 mL Hair Straightener 100 mL/g Shampoos 200 mL Permanent Wave Lotion and 100 mL @ Neutralizers Tonics 100 mL Dressings, other grooming aids 100 mL/g Wave Set 100 mL 3.1.2.2 Hair Coloring Preparations Hair Dyes, Shampoo-ins and 100 mL Hair Rinse Hair Lighteners, bleaches 100 mL 3.1.3 Make-up and Beauty Care Blushers 1 commercial presentation Lipsticks - do - Foundations - do - Pressed powder - do - Eye area make-up Eyebrow pencil 2 commercial presentation Eyeliner - do - Eyeshadow 20 g Eye Lotion 20 g Eye make-up remover 20 g Mascara 20 g 3.1.4 Baby ProductsShampoos 100 mL/g Lotions, Colognes - do - Oils/Creams - do - Powder - do - 3.1.5 Fragrance Preparations Colognes/Toilet Water 100 mL Powder (Dusting, Talcum) 100 g Perfume 1 commercial presentation 3.1.6 Others 3.1.6.1 Manicuring Preparations Cuticle remover 100 mL Nail Polish & Enamel 30 mL Nail Polish Remover 100 mL 3.1.6.2 Oral Hygiene Dentrifices 100 mL Mouthwashes/Breath Fresheners 100 mL 3.2 Microbiological Test - for selected cosmetic preparations 3.2.1 Additional samples of not less than 50 g in separate commercial presentation NOTE: In cases where there is a need for a retest, additional samples will be requested.

4. Household Hazardous Substances 4.1.1 Category I Petroleum Distillates Cigarette Lighter fluid 100 mL Solvent Points, Lacquer, Thinner, 100 mL Mineral Spirits Paints, Lacquers, varnishes 100 mL Adhesives 2 commercial presentation each (tubes) 50 mL/g 4.1.2 Category II Polishes and Waxes Furniture Polish 100 mL/g each Shoe polish - do - Floor polish - do -4.1.3 Category III Cleanser and Detergent Bleaches 200 mL Cleansers 100 mL Detergent/soap 200 g/mL Fabric softener 100 mL Fabric cleaner 200 mL Glass cleaner 200 mL Toilet bowl cleaner 200 mL Alkali cleaners 200 mL 4.1.4 Category IV Do it Yourself and Hobby Items Glues 100 mL/g 4.1.5 Category V Room freshener 100 mL Deodorant Cake 20 g 4.1.6 Disinfectant Phenolic compounds/Quarternary 200 mL Ammonium Compounds 5. Food Chemicals, direct and indirect 250 g 6. Boiler water additives 250 g 7. Printing Inks/Paints 50 g 8. Protective Coatings/Prints coated on metal or glass size1" x 3", 10 pcs.

9. Diagnostic Reagents 1 set 10. Plastic Food Packaging Containers 6 pcs. 12" x 12" 11. Food/Food Products (Pesticide Residue 250 g Analysis) This Memorandum Circular shall take effect immediately. Adopted: 07 Sept. 1994

(SGD.) QUINTIN L. KINTANAR, M.D., PH.D. Director - CESO ISource: Supreme Court E-Library