Guidelines for Current Good Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug Manufacturers

August 13, 2013

DOH ADMINISTRATIVE ORDER NO. 2013-0022

 

I. Rationale

Whereas, it is the policy of the State as embodied in Article II, Section 15 of the 1987 Constitution to protect and promote the right to health of the people and instill health consciousness.

Pursuant to Republic Act 9711, it is the declared policy of the State to adopt, support, establish, institutionalize, improve and maintain structures, processes, mechanisms, and initiatives that are aimed, directed and designed to protect and promote the right to health of the Filipino people.

And pursuant to Republic Act No. 7394, also known as "The Consumer Act of the Philippines", it is the policy of the State to protect the interest of the consumer, promote his general welfare and to establish standards of conduct for business and industry. Towards this end, the State shall implement measures to achieve for the protection against hazards to health and safety and protection against deceptive, unfair and unconscionable sales acts and practices.

Administrative Order 43 series of 1999 was created to institute and uphold the cGMP in the Philippines. As stated in Section 2, Drugs shall be manufactured using methods, facilities and control procedures adequate to preserve their identity, strength, quality and purity. Manufacturers must establish and maintain quality systems to assure that drug products are manufactured, held, and distributed in accordance with the cGMP and with the product application or license commitments. aETASc

Drug importers shall be responsible in ensuring that the products brought to the Philippines are manufactured in accordance with cGMP.

Pursuant to Administrative Order 56 s. 1989, if an establishment imports raw materials, active ingredients and/or finished products for use in the manufacture of drug products, the establishment must submit a (1) certificate that the manufacturer is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, and (2) evidence that the manufacturer meets FDA standards for local manufacturers.

An importer applying for registration or listing of drugs manufactured must provide an acceptable form of evidence to show that the drug is manufactured at an acceptable standard referred to as GMP Clearance of Foreign Drug Manufacturers. FDA Philippines shall inspect facilities to confirm manufacturers' compliance to cGMP. If inspection of the foreign manufacturer by FDA is necessary, the cost of inspection shall be borne by the applicant establishment.

This Order is issued under the authority conferred upon the Secretary of Health by virtue of section 26 (a) of RA 3720 as amended.

II. Objective

This Order aims to create and implement systems of evaluating, monitoring and assuring GMP compliance of foreign drug manufacturers who sell or offer for sale their drug products to the Philippines through submitted documentary evidences and GMP inspection, as appropriate.

III. Scope of Application

This Order shall apply to drug importers and foreign drug manufacturers. ICAcTa

IV. Definition of Terms

For the purpose of this order, the following terms shall mean:

a) "Drug Establishment" refers to drug manufacturers/repackers, drug importers, drug distributors, drug wholesalers or drug exporters and entities belonging to definition of establishment, as per RA 9711 and its implementing rules and regulations.

b) "Drug Manufacturer" means an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage sale or distribution: Provided, that the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies. A trader shall be categorized as a manufacturer.

c) "Establishment" means a sole proprietorship, a partnership, a corporation, an institution, an association, or an organization engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of health products, including the facilities and installation needed for its activities.

d) "GMP Evidence Dossier" refers to the documents used for the purpose of evaluating the GMP compliance of the foreign drug manufacturer such as, but not limited to, the Site Information/Master File, GMP Inspection report, GMP Certificates, Validation Records and other documents. ESCTIA

V. General Guidelines

1. The Food and Drug Administration (FDA) shall create guidelines on the submission, review, monitoring and archiving of GMP evidences of foreign drug manufacturers.

2. Drug Importers must obtain GMP Clearance for the foreign drug manufacturer(s) before the health products are registered.

3. The drug importer shall provide evidence, on a periodic basis, that the product has been manufactured with the acceptable GMP standards.

4. The drug importer shall inform FDA Philippines on any changes with the foreign drug manufacturer that may have a direct or indirect impact on the quality and safety of the product or material introduced in the Philippine market.

5. The FDA may request additional documents for the assessment of the GMP Clearance application. Such request shall be put into writing and copy furnished the drug importer.

6. The FDA reserves the right to conduct an inspection of any foreign drug manufacturer, irrespective of the documentary GMP evidence submitted to the FDA, even if there is a current GMP Clearance.

7. The FDA may refuse the issuance of and suspend or cancel the GMP Clearance where evidence exist that the manufacturer does not meet the acceptable evidence of the standard of manufacture. The FDA shall inform the drug importer in writing on the non-approval, suspension or cancellation of the foreign manufacturer GMP clearance.

8. The FDA shall create and maintain a records and database of the submitted documentations, reports and correspondences. EcDSTI

VI. Specific Guidelines

1. Authority to Evaluate and Monitor the GMP Evidence of Foreign Drug Manufacturers.

The FDA shall authorize the appropriate section, division or office, in charge of GMP, to re-evaluate, monitor GMP compliances of foreign drug manufacturers who sell or offer for sale their products in the Philippines.

2. The application for the foreign drug manufacturers clearance shall be as follows:

2.1. The drug importer from the Philippines or the authorized representative shall be guided using the Notes on Application Form to Request for GMP Evidence Evaluation (Annex A) and apply using the GMP Evidence Evaluation Form (Annex B) for each manufacturing site and attach relevant evidence of the manufacturing standard, and forward it to the FDA for evaluation.

2.2. The drug importer shall pay an evaluation fee for the submitted forms. The evaluation fee is non-transferable.

3. The GMP Evidence Evaluation Form and documents shall be assessed in accordance with the General Requirements for GMP Evidence Evaluation and other relevant rules and regulations of the FDA.

4. If approved, a GMP clearance letter will be issued bearing the following information:

4.1 The name of the manufacturer

4.2 The complete address of the manufacturing site

4.3 The date of issue and/or expiry of the document cTSDAH

4.4 The approved medicinal product(s) or approved type of medicinal products and dosage form(s)

4.5 The approved steps of manufacture at the site

5. If denied, a denial letter from the FDA will be issued with the reason for such denial. New GMP evidence shall be submitted via filing of a new application.

6. Where no satisfactory documentary evidence of compliance can be provided, the Philippine drug importer shall accomplish the Application Form for Foreign Drug Manufacturer GMP Inspection (Annex D) and pay the necessary fees.

7. The application should be filed by an authorized representative.

8. The importer shall submit:

a. GMP Evidence Dossier (Annex C) together with the completed application form.

b. Affidavit of undertaking (Annex E) that both the importer and manufacturer is agreeable to the on-site inspection.

9. The drug importer shall pay for the cost consisting of appropriate relevant inspection fee, travel and accommodation. Further, it is incumbent that the arrangement for the travel and accommodation be accomplished by them. The drug importer is also required to provide and shoulder the cost for a translator to be available, whenever necessary.

10. The appropriate fees for the Foreign GMP inspection can be paid upon the receipt of the notification from FDA or not later than 3 months from the scheduled inspection date. TcDHSI

VII. Documentary Requirements

A. Quality of documentation

A.1 Original certificates shall be submitted.

A.2 Where an original may not be obtained, a photocopy may be submitted provided all information on the copy must be clearly legible. Copies must be authenticated by the regulatory agency of the country of origin and/or a territorial Philippine consulate office.

A.3 Copies of documents from Food and Drug Administration Philippines need not be notarized.

A.4 Faxed, photocopied, scanned or emailed copies are not acceptable except for A.3.

A.5 All certificates and other supporting documents must be in English.

A.6 Bilingual certificates are acceptable provided one of the languages is English.

A.7 If the document has been translated, a statement attesting the accuracy of translation from the translator is required. The FDA may require verification of the translated documents.

A.8 The drug importer shall provide the following documents (as described in 2) issued by the relevant authority. The submitted documents shall bear the following information:

A.8.1 The name of the manufacturer SIDTCa 

A.8.2 The specific address including the building number, floor, street address of the manufacturing site. (P.O. Box is not acceptable)

A.8.3 The date of issue and/or expiry of the document

A.8.4 The approved medicinal product(s) or approved type of medicinal products, dosage form(s)

A.8.5 The approved steps of manufacture at the site if applicable

A.8.6 Date of last inspection

A.8.7 The standard of manufacture with which the product complies

A.9 Incomplete information shall not be accepted nor evaluated.

B. Acceptable evidence of the standard of manufacture

B.1 Where possible, documentation should generally be from a government authority that is recognized by FDA Philippines. The standard of GMP inspections from the relevant regulatory authorities of the following countries shall be acceptable:

B.1.1 PIC/S Members countries

B.1.2 Others countries

B.1.2.1 Japan Ministry of Health, Labour and Welfare

B.2 The acceptable GMP evidence issued by a competent authority listed may be in the form of:

B.2.1 GMP Certificate (Certificate of GMP Compliance); or

B.2.2 WHO Certificate of a Pharmaceutical Product; or

B.2.3 Manufacturer's License or Manufacturing Authorization incorporating the specific medicinal product(s)/dosage form(s). DTSIEc

B.3 The following documentation shall not be accepted as primary evidence of GMP compliance although they may be useful supporting documentation:

B.3.1 Copy of annual product registration certificate from US FDA

B.3.2 Annual Registration of Drug Establishment Certificate from US FDA

B.3.3 FDA Form 482 (Official FDA Notice of Inspection) and 483 (Official FDA Inspectional Observation Sheet)

B.3.4 Letter from FDA stating that no form 483 was issued

B.3.5 Other quality system certificate (e.g., ISO Certificate)

C. Validity of documents

C.1 The establishment shall provide new GMP evidence before the expiry date of the submitted documentary evidence of GMP conformance. Expired certificates/documents shall not be accepted.

C.2 GMP Certificates and inspection reports shall only be valid for three years after the date of the last inspection or until the expiry date shown on the certificate (whichever is earlier). If a certificate states that it is valid for more than three years after the date of inspection, it will only be accepted for a maximum of three years after the last inspection date. If a certificate has an expiry date less than three years after the inspection date, it will only be accepted until the stated expiry date. EHCcIT

C.3 There must be no qualifying statement on the GMP evidence that renders it invalid (e.g., a statement that 'the certificate is issued for the GMP and must not be used for any other purpose').

C.4 The new GMP evidence shall be submitted via filing a new application.

This Order shall be periodically reviewed by the FDA. The establishments shall be given a 1-year transition period to comply with the said requirement starting from the effectivity date of this Order.

VIII. Repealing Clause

Provisions of previous issuances which are contrary to those reflected hereon are modified, and /or repealed accordingly.

IX. Effectivity

This Order shall take effect after fifteen (15) days following its publication in a newspaper of national circulation and upon submission to the University of the Philippines Law Center.

(SGD.) ENRIQUE T. ONA, MDSecretary of HealthDepartment of Health

Annexes A to F of DOH Administrative Order No. 2013-0022

Published in The Philippine Star on August 15, 2013.