1. What is the provision of A.O. 56 s. 1989?
Pursuant to Section 26(a) in relation to Section 21(a) and 11(k) of Republic Act No. 3720, known as the Foods, Drugs and Devices, and Cosmetics Act as amended by Executive Order No. 175 s. 1987 and consistent with Republic Act No. 6675, known as the Generic Act of 1988, the following regulations are hereby promulgated governing drug establishments and drug outlets under the Bureau of Food and Drugs (BFAD).
In accordance with Section 3 Paragraphs 5 and 6 of R.A. 6675, any organization, company or business establishments in the pharmaceutical industry shall fall under the following general classification: I. Drug Establishment means any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines. This is covered by Chapter I below. II. Drug Outlet means drugstore, pharmacy, and other business establishment which sells drugs or medicines. This is covered by Chapter II below. 2. List down the minimum standards for pharmaceutical Equipments and machines.
MINIMUM STANDARDS FOR PHARMACEUTICAL MANUFACTURING EQUIPMENT/MACHINES

1.0. General Machinery and Equipment
1.1. Weighing Scale
1.1.1. 1 g. sensitivity
1.1.2. 1 kg. sensitivity
1.2. Labelling machine
1.3. Coding Machine
1.4. Facility for washing and drying bottles
1.5. Measuring glasswares
Laboratory apparatus including measuring glasswares, chemical supplies, filter paper
2.0. Additional Machine and Equipment needed for each dosage form:
2.1. Liquid/Suspension
2.1.1. Stainless Steel tank with stirrer of appropriate capacity
2.1.2. Jacketed kettle
2.1.3. Homegenizer
2.1.4. Stainless steel pail, assorted sizes
2.1.5. Deionizer or distilling apparatus
2.1.6. Stainless steel storage tank 500 L
2.1.7. Filter Assembly
2.1.8. Filling Machine
2.1.9. Filter-proof Capper
2.2. Tablets
2.2.1. Mixer/blender
2.2.2. Mill
2.2.3. Granulator
2.2.4. Drying Oven or fluidized-bed dryer
2.2.5. Blender/Sieves
2.2.6. Tablet Press
2.2.7. Dust Collector/Exhaust duster
2.2.8. Dehumidifier
2.3. Capsule
2.3.1. Mixer
2.3.2. Dehumidifier
2.3.3. Encapsulating machine
2.3.4. Dust Collector/exhaust system
2.4. Powder/Granule Preparation
2.4.1. Blender
2.4.2. Powder filling machine
2.4.3. Tamper proof machine
2.4.4. Dehumidifier
2.5. Sterile products (Opthalmic, etc.)
2.5.1. Stainless steel tank with stirrer
2.5.2. Stainless steel storage tank
2.5.3. Membrane filter assembly
2.5.4. Laminar Flow System
2.5.5. Filling Machine
2.5.6. Capping Machine
2.6. Ointment/Cream
2.6.1. Mill
2.6.2. Stainless tank with stirrer, jacketed
2.6.3. Filling Machine
2.6.4 Crimper
2.7. Small Volume Parenteral Products
2.7.1. Vial washer/rinser
2.7.2. Pyrogen-free distilling apparatus
2.7.3. Storage Tank g.g.
2.7.4. Stainless Steel tank with stirrer
2.7.5. Membrane filter assembly
2.7.6. Laminar Flow system
2.7.7. Ampule filter and sealer
2.7.8. Vial filter and sealer/crimper
2.7.9. Fillin gmachine for liquid
2.7.10. Sterilizer/autoclave
2.7.11 Depyrogeneting oven
2.8. Large Volume Parenteral Products
2.8.1. Water softener
2.8.2. Carbon filter
2.8.3. Deionizer
2.8.4. Fetilling unit
2.8.5. Stainless steel tank with stirrer
2.8.6. Stainless steel storage tank
2.8.7. Membrane filter assembly
2.8.8. Bottle Stopper washer
2.8.9. Laminar flow assembly
2.8.10. Salter and sealer/crimpter
2.8.11. Wash equipment
2.8.12. Autoclave/sterilizer
2.8.13. Dipyrogenating oven
2.9. Penicillin Preparation
2.9.1. Separate areas, separate area and entrance from non-penicillin products.
2.9.2. Separate equipment outlay based on specific dosage form.
2.10. Optional equipment and Machine
2.10.1. Coating Pan )
2.10.2. Mill ) for sugar coated tablet
2.10.3. Polishing Pan )
2.10.4. Sprayer - for film coating
2.10.5. Sachet filler
2.10.6. Strip sealing machine
2.10.7. Blister pack machine
2.10.8. Tablet/Capsule Counter

3. What are the grounds for revocation and suspension of LTO license of drug establishment?
From A.O. 56 s. 1989 Chapter I Drug Establishments Section 4
4. Administrative Sanctions
4.1. Grounds for Revocation of LTO
4.1.1. Misrepresentation of any material fact in the application for LTO and in any documentation used as a basis for issuing the LTO.

4.1.2. For manufacturer and traders: any deficiency in GMP that is likely to result in adulterated, misbranded, substandard or unsafe products as determined by
BFAD. This includes among others, grossly inadequate premises, lack of key technical and professional personnel, lack of key equipment in production or quality control, poor or inadequate process control and inadequate or improper documentation of the production process.

4.1.3. For distributors: distribution of fake, misbranded, adulterated or unsafe drug products. 4.1.4. Violation of BFAD standards of quality, efficacy, purity and safety of drug products.

4.1.5. Sale or distribution of antibiotic products without batch certification by BFAD.

4.1.6. Failure to take adequate remedial or corrective measures for deficiencies identified in accordance with requirements of BFAD.

4.1.7. Failure to keep up to date, secure, orderly, and easily inspected records that would indicate continued compliance with standards.