REPUBLIC OF THE PHILIPPINES DEPARTMENT OF HEALTH BUREAU OF FOOD AND DRUGS Filinvest Corporate City, Alabang, Muntinlupa City June 11, 2001 BUREAU CIRCULAR No. _6-A___ series 2001 SUBJECT: REVISED MINIMUM REQUIRED SAMPLES FOR LABORATORY ANALYSIS For the information and guidance of all concerned, in accordance to M.C. No. 20, s. 1994, hereunder is the list of the minimum required samples for laboratory analysis. I. | GOVERNMENT DELIVERIES 1. PHARMACEUTICAL PRODUCTS 1.1 Physico-Chemical Test Sample Type ‘Amount Required" Tablet/Capsule T commercial presentation (minimum of 50 pieces) ‘Liquid /Suspension Solution 60 ml x 6 bottles 120 ml _x 6 bottles ‘Ointment/Cream/Lotions * 5g x 6 tubes/bottles 5 to 10g x 6 tubes 15 to 30g x 4 tubes Granules/Powders for Suspension 30 ml x 6 bottles 60 mlx 6 bottles ‘Kerosol 3 commercial presentation ‘Suppositories 25 pieces ‘Transdermal Drug Delivery Systems | _Notless than 50 pieces Tnjectables: 1 ml to2ml 10 vials/ampules, 5 ml to 10 ml 10 vials/ampules 20 ml to 100 mi 5 vials/ampules tablets/ capsules delivered exceeding 10,000 snits 2 ampules delivered exceeding 1,000 units > creams, lotions, ointments exceeding 1,000 units |1) 13 Sterility Test Sample Ty ‘Amount Required? Liquid Preparations: 1 mito 100 ml Minimum of 20 bottles 500 ml to 1000 ml 6 bottles Solid Preparations: Less than 50 mg. 50 mg ot mote but less than 200 mg } Minimum of 20 bottles 200 mg or more Ointments Microbiological Test (for samples where dosage forms are not indicated, the amount required refers to ‘the equivalent weight of the test material) ‘Sample Type ‘Amount Required [ Tiguid! Syrup/Solution /Suspension at least 60 ml_(2 x 30 ml or 1 x 60 ml) ‘Granules for Suspension at least 120 mil (2.x 60 ml or 1 x 120 ml) ‘Nasal Solution at least 20 ml (2 x 10 ml or 1 x 20 mi) Ointment/Cream/Gel at least 259 (5x5 gor3x 10g) Topical Lotion at least 30 ml (3 x 10 ml or 2x 20 ml) For Clobetasol Propionate Cream, atleast 45 g (9x 5g or5x 10) Ointment, Topical Solution ‘Number of tablets/capsule equivalent to: Tablet/Capsule atleast 20 g For Ergoloid Mesylates Capsule at east 60 g ‘Powder for topical use atleast 40. g ‘Aerosol for inhalation atleast 30 ml 2x 15 mlor1x 30m) | Tasulin at least 20 g Inulin at least 60 g Pectin at least 20 g 2. MEDICAL DEVICES 21 22 Physico-Chemical Test 6 units of the product except 10 units of sutures, 10 units of syringes with volume capacity of 0.5 to 5 ml (in their commercial presentation) Sterility Test 20 units of the product in its commercial presentationIL COLLECTED/PRIVATE SAMPLES 1. PHARMACEUTICAL PRODUCTS 1.1 Physico-Chemical Analysis Sample Type ‘Amount Required (Oral Liquid Preparations 4x 60 ml or 4x 120 ml ‘Alcohols Minimum of 3 bottles External Liquid Preparations 4 bottles Tablets, Capsules and Suppositories Minimum of 30 pieces contained in box/bottle Ointments/Cream 3x5g Injectables: Imlto 2ml 10 vials /ampules 5mlto 10 ml 5 vials/ampules 20 ml to 100 ml 3 vials/ampules In cases where there is insufficient stock of alleged suspicious ddrugs/targeted products, sampling may only be undertaken when there is evidence of violation such as labeling deficiencies or evidence of improper storage. 1.2 Microbiological Test Please refer to item 1.3 of Section I. Government Deliveries 13° Sterility Test Sample Type ‘Amount Required ‘Sterile Water for Injection 20 bottles: 2. COSMETICS & HOUSEHOLD HAZARDOUS PRODUCTS 21 — Physico-Chemical Analysis 2 units of the products in its commercial presentation 2.2 Microbiological Analysis = 2 units of not less than 50 ml of the prepackaged product (in its commercial presentation). actosols_of powders, soaps, liquids and other materials - 2 units of not less than 50 grams of prepackaged product (in its commercial presentation).| 3. FOOD/FOOD PRODUCTS 31 32 Physico-Chemical Analysis 2 units of prepackaged product (in its commercial presentation) ¢ composite weight is not less than 250 grams plus 200 grams if heavy metals analysis is required/requested in addition to other physico-chemical tests. Microbiological Analysis 2 units of not less than 100 grams of prepackaged product (in its commercial presentation). This may not apply if the purpose of the examination is conformity assessment 10 microbiological speafications — with preseibed sampling plan, At least 3 units of prepackaged product (with same lot identification code), if the product is thermally processed low-acid food or acidified food packed in hermetically sealed containers, eg, can, bottle, retortable pouch. 6 units if the weight per package is less than 100 grams. 5 units of bottle drinking water (with the same lot identification code) of not less than 300 ml pet bottle. 4. MEDICAL DEVICES Please see item 2 Section I. Government Deliveries 5. PACKAGING MATERIALS 5A FOR PHARMACEUTICAL PREPARATIONS SAMPLE TYPE AMOUNT REQUIRED Platbottles/IV Infusion Bags 4 pieces Polyampoules 12 pieces ‘Ophthalmic Containers 12 pieces Vials 12 pieces ‘Nebulizers/Rotahalers/Diskhalers | _ 2 pieces: Plastic Container for: Suspension/Syrup 10m) 8 pieces 30 ml to 60 mi 6 pieces greater than 60 ml A pieces (Glass Vials B pieces5.2 FOR FOOD PRODUCTS SAMPLE TYPE AMOUNT REQUIRED wo Plastic of glass bottles/polybags 6 pieces ‘Sheets or wrappers 8 pieces of 12” x 112” ‘Metal cans 6 pieces . DIAGNOSTIC REAGENTS ‘Minimum of 1 set . FOOD CHEMICALS SAMPLE TYPE AMOUNT REQUIRED Direct and Indirect 100 grams Fortificant 50 grams m. BAT TION SAMPLE TYPE AMOUNT REQUIRED Tablet/Capsule: (in its commercial presentation) in blister pack 70 pieces in sealed bottle min. of 50 pieces ‘Powder for Suspension /Solution: Less than 50 ml 6 bottles More than 50 ml 4 bottles ‘Ointment/Cream 4 pieces Tnjectables: 2ml 10 vials/ampules 5 ml to 10 ml 4 vials ampules 20 ml to 100 ml 4 vials ampules Bulk Material 50g ‘This Memorandum Circular shall take effect immediately. Director