Registration of a Drug Establishment

Manlangit, Kimberly I. Manuel, Jefferson B. Manugas, Shirmagne Fatima E. 4A-Pharmacy

Licenses required for the operation of a drug establishment

License to operate Philippine Food and Drug Administration
As drug manufacturer (includes veterinary products)

Certificate of current Good Manufacturing Practice ISO accreditation Certification International

OHSAS 18001:2007
International standard for occupational health and safety management systems gives you a framework to identify, control and reduce the risks associated with health and safety in your workplace.

ISO 14001:2004
International Standard for Environmental Management Systems designed to address the delicate balance between maintaining profitability and reducing environmental impact

Licenses required for the operation of a drug establishment

ISO accreditation Certification International
ISO 9001:2008
Quality management system standards Enables you to demonstrate your commitment to service quality and customer satisfaction

PDEA P6 license
FOR THE MANUFACTURE, RECYCLE, IMPORTATION, EXPORTATION, REPACK, WHOLESALE, TRADE, DISTRIBUTION,RETAIL, END-USE /LAB USE OF PRECURSOR AND ESSENTIAL CHEMICAL&/OR MIXTURE/S
License to conduct laboratory analysis or technical research using PECs

PNP license to possess explosives

in compliance with the Firearm and Explosives Law needed in order to possess/store explosives/explosives ingredients being monitored by PNP such as nitric acid, nitrates and chlorates

General and additional requirements for the licensing of a drug establishment set by FDA
A standard petition form containing among others the name, age, citizenship and a passport size picture (5x5) of the petitioner and other pertinent circumstances pertaining to the proposed drug establishment including the place where it is to be established. List of products to be manufactured or distributed identified by their generic names and brand names if any. An authenticated photocopy of contract of Lease for the space to be occupied if the applicant does not own it. A Batch Distribution Record Book duly registered with BFAD. A contingency plan or procedure for a systematic, effective and prompt recall in case any of its products is found violative and ordered recalled from the market by the BFAD. An orderly and secure system of filling up to date invoices from suppliers and buyers identifying lot numbers or batch numbers of manufacturers stock pursuant to BFAD Memo Circular No. 001 s.1983.

Application of LTO from FDA

Laws affecting the operation of the manufacturing laboratory

Administrative Order No. 43 s. 1999: Current Good Manufacturing Practice Guidelines for Drugs Administrative Order No. 55 s. 1988: Requirements for Labelling Materials of Pharmaceutical Products Administrative Order No. 56 s. 1989: Revised Regulations For The Licensing Of Drug Establishments And Outlets Administrative Order No. 85 s. 1990: Requirements for Labelling Materials of Certain Categories of Products Containing Two or More Active Ingredients Bureau Circular No. 21 s. 1999: Guidelines for the Evaluation of Brand Names for Products to be Registered with the Bureau of Food and Drugs BFAD Regulation No 2 s. 1986: Assignment of Brand Name and/ or Generic Names for a formulation of a Drug or Pharmaceutical Specialty Republic Act No. 6675: An Act to Promote, Require and Ensure the Production of an Adequate Supply, Distribution, Use and Acceptance of Drugs and Medicines Identified by their Generic Names

Manufacturers who were given CGMP certificate by FDA

As of 30 July 2012
Accord Bio Laboratories Acme Gas Corporation Air Liquide Phils. Inc. (Pasig City) Air Liquide Phils. Inc. (Balamban, Cebu) Allied Pharmaceutical Laboratories, Inc Mabalacat Am-Europharma Corporation - Branch A.M. Rieta Chemicals Trading & Manufacturing Amherst Laboratories, Inc. Amherst Parenterals, Inc. Ashford Pharmaceutical Laboratories, Inc. Asian Antibiotics, Inc Atgas Traders Ava Fleming Laboratories International, Inc. Balangcas Industrial Gases Corporation Baxter Health Care Philippines, Inc. Cagayan de Oro Gas Corporation Caloocan Gas Corporation Compact Pharmaceuticals Corporation Diamond Laboratories, Inc. Doctors Pharmaceuticals, Inc
Euro-Med Laboratories Phil., Inc. Mandaluyongv Gel Pacific, Inc. Gruppo Medica, Inc. Hizon Laboratories, Inc. (Quezon City) Ingasco, Inc. (Pampanga) Ingasco, Inc. (Batangas) International Pharmaceuticals, Inc. (RDII-RVIIDM-033) Interphil Laboratories, Inc. (RDII-RIV-DM-21) Jelma Philippines, Inc. (Drug Mfr./Repacker) J.M. Tolmann Laboratories Inc. La Croesus Pharma, Inc. Linde Philippines (South), Inc. (formerly Southern Industrial Gases Philippines, Inc.)(Buanoy, Balamban, Cebu) Linde Philippines (South), Inc. (formerly Southern Industrial Gases Philippines, Inc.)(Ormoc City) Linde Philippines (South), Inc. (formerly Southern Industrial Gases Philippines, Inc.)(Bago, |Negros Occidental) Lloyd Laboratories, Inc. Lorenzo C. Reyes Laboratory, Inc. Manufacturing Services & Trade Corporation Medi-Rx, Inc. Medgen Laboratories, Inc. Metrolab Industries, Inc.

Morishita Seggs Pharmaceuticals, Inc. - Sta Maria Branch New Dagupan Metro Gas Corporation Northfield Laboratories, Inc. Novagen Pharmaceutical Co., Inc. Pascual Laboratories, Inc. Pentagon Laboratories, Inc. Philmed Laboratories, Inc. Pryce Gases, Inc.-Branch Scheele Laboratories Phils., Inc. Splash Corporation Square Pharmaceuticals, Inc Swisspharma Research Laboratories, Inc. Sydenham Laboratories, Inc. Talan Haplacious Herbal Manufacturer Telstar Manufacturing Corporation United Laboratories, Inc.