CENTRAL LABORATORY. Frontline Service : Conduct of Routine Laboratory Analysis. Customer : Government Agencies, FDA Inspectors, Other Stake Holders

Transcription

1 CENTRAL LABORATORY Frontline Service : Conduct of Routine Analysis Customer : Government Agencies, FDA Inspectors, Other Stake Holders Requirements : Duly Accomplished Request for Analysis FDA Circular No Minimum Number of Samples Units Required for Each Test Analysis FDA Circular No Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods Schedule of Availability of Service : Mondays to Fridays, 8:00 am - 5:00 pm Fees : A.O. No. 50 s Legal Research Fee (LRF) CLASSIFICATION 1. Physico-chemical Analysis Drugs and Antibiotics o Visual Examination o Assay/Potency (single 1, component) o Assay/Potency (multi 2, component) o Dissolution Test 2, o Disintegration Test o Hardness Test o Identification Test o Purity test / Related Substances o Moisture content o Loss on Drying o ph o Vitamins Vitamin A 1, Vitamin B1, B2, B6 2, Vitamin C (Ascorbic Acid) Vitamin E FEES (Php)

2 Other Vitamins o Minerals In Vitro Diagnostic Reagents 1, Medical Devices 1, Cosmetics o Assay 1, o Identification test o Volatile / Non-volatile matters Food Products o Moisture o Protein 1, o Fat/Oil o Starch o Glucose o Sucrose o Lactose o Crude fiber o Dietary fibers 2, o Total Solids o Soluble Solids o Water-Insoluble Solids o Ash o Acid-insoluble ash o Saponification number o Viscosity o Refractive Index o Peroxide Value o Free fatty acids o Permanganate Oxidation Number (PON) o Total Acidity o Water activity o Vacuum o Minerals 1, o Amino Acids (LC) 2, o Proline o Additives Nitrate Nitrite Sodium Benzoate Sorbic acid Food color per color Sodium metabisulfite

3 Bromates BHT BHA Aspartame Saccharin Monosodium glutamate o Micronutrients Vitamin A 1, Vitamin E 1, Beta Carotene 1, Vitamin C Vitamin B1, B6 1, Vitamin B1, B6, 1, Niacin Iodine Iron o Contaminants Borax Aflatoxin 2, Total heavy metals Lead Cadmium Chromium Arsenic Mercury Tin Cyanide Histamine 1, Filth Formalin Pesticide residue 2, Alcohol content 1, Gas volume Total Soluble Solids (Brix) ph Caffeine Food Supplements 4, Beverages o Alcohol content 1, o Gas volume

4 o Total Soluble Solids (Brix) o ph o Caffeine Bottled water 2, Food Chemicals / Additives o Direct 1, o Indirect Containers / wrappers o Migratable Substances 1, o Plastic additives o Cellulosic Materials for 1, Pesticide Residue o Materials Testing Microbiological Assay (Potency of 2, Antibiotics) Sterility Test (Injectables, Medical 2, Devices and Large Volume Parenterals) Microbial Limit o Aerobic Plate Count o Aerobic Halophilic Count o Aerobic Thermophilic Count o Coliform Plate Count o Coliform / E. coli (MPN) o Fecal Streptococci o Yeast and Mold Count o Halophilic Yeast Count o Staphylococcus aureus count o Pseudomonas aeruginosa o Identification of Microorganisms Presumptive Test Confirmatory Test 2, per organism (complete biochemical reaction) Commercial sterility of 1, thermally processed foods in hermetically sealed containers Bioassay Tests o Bacterial endotoxin Test 4, (LAL)

5 Duration of Activities : 7-80 calendar days* STEP How to Avail of the Service: CLIENT/ APPLICANT AGENCY ACTION ACTION Assesses and evaluates the Request for Analysis 1 Submits Request for Analysis (per request) Receives and encodes the Request for Analysis OFFICE/ PERSON RESPONSIBLE LOCATION OF OFFICE Admin Aide Room 223, Main Building Admin Aide DURATION OF ACTION 15 minutes 20 minutes Forwards to concerned section Lab Tech/Admin Aide 2 Recording and scheduling Section concerned Sample handling /storage Pre-evaluation per label/test required 3 Testing (1) Physico-chemical - Food, Drug, Cosmetic, HHS, Medical Devices) a. Government Deliveries 1. DOH 2. Other Government agencies b. Collected Samples 1. Fake and suspicious drugs 2. NCR, RFO, LGU c. Registration Samples 1. Donations 2. Referrals d. Complaint Samples 15 minutes 60 minutes days days days days days days 7-38 days (2) Microbiological Analysis a. Routine Microbiological Test 9-16 days*

6 b. Detection and Enumeration of Microorganisms including Confirmatory Test c. Commercial Sterility Test (3) Sterility Test (Drugs and Medical Devices) (4) Bioassay a. Bacterial Endotoxin Test 4 Data Recording and Computation Antibiotic Section (Main Building) Experimental Animal House ( Building) days* days* 38 days* 9-38 days* minutes (may vary depending on the number of test request/ parameters reported) 5 Data/Results Evaluation 10 minutes 6 Preparation of Test Reports Section Clerk minutes 7 Signing of Test Reports Section Head 8 Forwards signed Test Report at the Office-of-the- Chief (CL) Section Clerk 3 minutes 5 minutes 9 Releasing of Test Report to Releasing Lab Tech Room 223, Main Building 5 minutes 10 Releases Test Report to requesting party Releasing Staff Room 106 ( Releasing) 5 minutes *includes the time for Steps 1, 3 to 8