Draft for Comments || Revised Rules of Procedures and Requirements for the Food and Drug Administration (FDA) Accreditation of Testing Laboratories Repealing FDA Order No. 2012-001

All comments shall be submitted using the Comment Template Form to [email protected], copy furnish [email protected] on or before 18 August 2022.

 

I. BACKGROUND

The “Food, Drugs and Devices, and Cosmetics Act,” also known as Republic Act No. 3720 as amended by Executive Order No. 175, was enacted to implement the stated policies of the 1987 Constitution, which required the State to protect and promote the people’s right to health and to instill health consciousness in them; adopt an integrated and comprehensive approach to health development; and carry out appropriate health manpower development and research, responsive to public health needs and problems; the Department of Health (DOH) mandated through the FDA, to adopt measures that will ensure pure, safe, efficacious and good quality supply of food, drug, cosmetics and devices in the country.

Subsequently, RA No. 9711 otherwise known as the “The Food and Drug Administration Act of 2009” was promulgated, further amending RA No. 3720, empowering the Food and Drug Administration (FDA) to accredit private testing laboratories that may conduct testing, assay and examination of samples of regulated health products, among others. Thus, FDA Order No. 2012-001 was issued to provide the rules and regulations on the procedure for accreditation of private testing laboratories as stated in Book II, Article IV, Section 2, of the Implementing Rules and Regulations (IRR) of RA No. 9711.

With the increasing number of health products in the country, their safety, quality, efficacy, and purity must at all times be assured, as such testing is important in verifying their compliance with regulatory and statutory requirements. Thus, the FDA needs to increase its testing capability and may call upon other government and private testing laboratories to carry out a much wider range of analysis on health products.

Accordingly, with the aim to provide streamlined procedures and definite timelines that are conducive to efficient delivery of services in accordance with Republic Act 11032 or the Ease of Doing Business and Efficient Government Service Delivery Act of 2018, this Circular is hereby issued repealing for this purpose the FDA Order No. 2012-001 entitled “Rules of Procedures and Requirements for the Food and Drug Administration’s Accreditation of Private Testing Laboratories.”

II. OBJECTIVES

This Circular is hereby formulated to provide updated guidelines in accreditation of testing laboratories which caters testing of health products within the mandate of FDA Specifically, this Circular aims to:

A. Provide rules of procedure and requirements in the accreditation of testing laboratories;

B. Ensure that the testing, assay, examination, measurement and analytical results/reports of health products from accredited testing laboratories conform to the standards, processes and specifications of FDA-Philippines; and

C. Create collaborative activities in strengthening the post-marketing surveillance system to provide safe and quality health products in the country.

III.       SCOPE

This Circular shall apply to private testing laboratories seeking accreditation with the FDA as defined herein and in the IRR of RA No. 9711. Government testing laboratories voluntarily seeking FDA accreditation shall also be covered by this issuance.

IV. DEFINITION OF TERMS

1. Assessment – a process undertaken by an accreditation body to determine the competence, capability and conformance of a laboratory based on particular standard(s) and other normative documents for a defined scope of accreditation. It is also a process that systematically examines the short- and long-term consequences, in terms of health and resource use of the application of a health technology, a set of related technologies or a technology related issue.
2. Government testing laboratory – a government owned laboratory that conducts testing, assay, calibration, examination, measurements, or analytical services on health products. Government laboratories may voluntarily apply for accreditation from FDA and shall follow the provisions of these guidelines.
3. Health Products – are foods, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/urban hazardous substances and/or a combination of and/or derivatives thereof. It shall also refer to products that may have an effect on health which require regulation as determined by the Department of Health, through FDA-Philippines.
4. Laboratory Accreditation – an attestation conveying formal demonstration of a laboratory’s competence and capability to carry out specific scientific and technical tests or analytical services with respect to health products. As a regulatory agency, the FDA is able to provide laboratory accreditation through formal acknowledgement of testing laboratories certified by an accrediting body recognized by FDA. Accredited laboratories will support the testing needs of FDA.
5. Private testing laboratory – a legal entity, other than government testing laboratories, that engages in the business of conducting test, calibration, assay, examination, measurements, or analytical services with respect to health products.
6. Remote Assessment – a virtual audit of testing laboratories using information and communication technologies (ICT) allowing auditors to communicate with the auditee and access documented information when “face-to-face” methods are not possible or desired.
7. Surveillance audit – are on-site visits in the accredited laboratory, undertaken by an accreditation body to ensure compliance with the accreditation requirements and or whenever there are significant changes from the laboratory operation.

 

V. GUIDELINES

A. The following are the application requirements for accreditation:

1. Duly notarized Accomplished Petition Form (Annex A)
2. Copy of valid ISO 17025 Certificate of Accreditation with defined Scope of Accreditation issued by Philippine Accreditation Bureau (PAB) and its validity is within six (6) months prior to the date of application with FDA.
3. Copy of Laboratory Quality Manual and Standard Operating Procedures (SOPs).
4. List of FDA regulated health products applied for Chemical and Microbiological Testing and its PAB approved signatories (Refer to Annex B: FDA Health Products for Chemical Testing and Annex C: FDA Health Products for Microbiological Testing)
5. Location map of the laboratory
6. Copy of latest PAB assessment findings with corresponding corrective actions
7. Floor layout with appropriate scale reflecting laboratory areas
   
   B. All applicant testing laboratories shall adhere to the following application procedures:

1. Submit requirements identified above to FDA Common Services Laboratory Receiving-Releasing Unit (CSL-RRU) which will be given a Document Tracking Number (DTN).

 

2. The application shall be forwarded by CSL-RRU to the FDA Laboratory Accreditation Team to verify the completeness of submitted documents. If the requirements are incomplete, the application is rejected and the applicant will be informed on the result of the pre-evaluation indicating the noted discrepancies. If complete, the tentative date of audit is scheduled. A remote assessment may be considered by the FDA Accreditation Team based on the set criteria (Refer to Annex D).

 

3. Notice of Audit will be sent to the applicant for confirmation within seven (7) working days after its receipt. No response or confirmation would entail cancellation of the assessment schedule.

 

4. The FDA Laboratory Accreditation Team shall conduct the on-site/remote assessment on the agreed scheduled date and furnish the applicant a written report with findings and recommendations.

 

a. For applications with no deficiencies noted during the on-site/remote assessment, the FDA Laboratory Accreditation Team shall recommend the issuance of the Certificate of Accreditation together with the Scope of Accreditation and Approved Signatories.

 

b. For applications with deficiencies noted during the on-site/remote assessment, applicants will be given a maximum of three (3) chances to address the deficiencies. Applicants are required to submit its first Corrective Action Plan (CAP) for the findings within thirty (30) calendar days and fifteen (15) calendar days for the second and third CAP when applicable. The period to rectify the deficiencies noted shall be non-extendable except in cases of fortuitous events or force majeure but in no case to exceed another fifteen (15) calendar days. The entire accreditation process must be completed within six (6) months from the date of the on-site/remote assessment. Exceedance of the prescribed period would discontinue the assessment and the application cancelled.

 

i. Once the finding(s) have been cleared, the FDA Laboratory Accreditation Team shall issue an audit close out report and recommend the issuance of the Certificate of Accreditation together with Scope of Accreditation and Approved Signatories.

 

ii. Non-compliance of the deficiencies shall mean disapproval of application. Likewise, uncleared CAP from the last evaluation shall mean denial of application for laboratory accreditation.

 

5. Secure payment to all fees (Audit Fee, Accreditation Fee and Legal Research Fee (LRF)) through the implemented payment system collection prescribed by the FDA.

 

6. Certificate of Accreditation (COA) or denial, with Approved Scope of Accreditation and Signatories, shall be issued within four (4) working days after acknowledgement of payment and copy of the official receipt.Note of the following schedule of fees:

 

Private testing laboratories which seek accreditation shall be assessed and shall pay the applicable laboratory audit and accreditation fees in accordance with the existing schedule of fees prescribed in Department of Health Administrative Order No. 2012-0024. Government testing laboratories shall not pay audit and accreditation fees, although transportation allowances of the assessors shall be covered by the applicants. Fees paid are non-refundable and non-transferable.

 

Schedule of Fees:

1. Audit of Testing Laboratory (per visit)
Within Metro Manila	Php 10,000.00 + transportation cost
Outside Metro Manila	Php 10,000.00 + per diem/per inspector + transportation cost
2. Accreditation of Testing Laboratory (per year)
Accreditation Fee	Php 20,000/year validity of accreditation

 

3. Legal Research Fee – 1% of the total amount

 

 D. For the granting of accreditation, the following shall be performed:

 

1. The FDA shall issue a COA with the Scope of Accreditation and Approved Signatories, the effectivity of which shall be dependent on the validity of the COA issued by PAB, but in no case shall it be for a maximum period of five (5) years subject to compliance to, and application of Book II of the Rules and Regulations Implementing RA 9711 FDA Act 2009, Article 4 (Laboratory Accreditation).
2. Any changes in the accreditation, with respect to the approved defined Scope of Accreditation issued by PAB for the particular test or types of tests covered by the Scope of Accreditation, location of the laboratory and significant changes that will trigger the change in the accreditation issued by the PAB, shall be treated as new and will require filing of new application following the above requirements and procedure.

 

E. Application for renewal of COA issued by the FDA shall be filed at least three (3) months prior to expiration of the existing accreditation. The above procedure for initial application shall be followed by submitting specified requirements and payment of the prescribed accreditation fee including on-site assessment fee and legal research fund.

 

F. After the grant of accreditation, laboratories may be subjected to surveillance activities. The purpose of a surveillance audit is to determine whether or not an accredited laboratory continues to fulfill the requirements set for accreditation. A remote surveillance assessment may be considered by the FDA Accreditation Team based on the set criteria (Refer to Annex D). Necessary fees shall be imposed for the surveillance audit as stipulated in Section V-C of this Circular.

G. Denial, Suspension and Cancellation of Certificate of Accreditation (COA)

 

Any or all of the following instances, in so far as applicable, shall be a ground for the disapproval of an application for accreditation, or cancellation or suspension of an existing accreditation, motu proprio or upon petition, to wit:

 

1. The requirements submitted or based on audit/inspection show that the laboratory does not meet the prescribed standards followed by the PAB or FDA;
2. The accreditation from the PAB has expired or has been canceled, suspended, or otherwise withdrawn;
3. The applicant fraudulently filed or misrepresented, falsified or withheld any relevant data or information regarding the laboratory, its equipment or the methods used in, or the facilities and controls used for, the conduct of test, calibration, assay, examination, measurement, or analytical service with respect to samples of health products or its accreditation was obtained fraudulently or contrary to the provisions of this Circular;
4. The applicant conducts testing which is not within the scope of activity in the Certificate of Accreditation;
5. Such other grounds as may be provided by relevant laws, rules and regulations.H. Responsibilities of the Accredited Testing Laboratory

 

1. An accredited laboratory shall keep and maintain all records of every testing conducted in a manner, and for a period, provided under FDA regulations and make them readily available at any time for purposes of inspection, verification and for audit by the officers authorized by the FDA.
2. The accredited laboratory shall allow the FDA full access to other records, such as, but not limited to, raw data, contracts and receipts, any laboratory equipment and facilities and shall provide the FDA, it so requests, test reports, raw data, methods of analysis and other pertinent documents.
3. An accredited laboratory shall inform and notify the FDA in writing of any findings of non-conformance in the test results/analysis conducted of a marketed health product within forty-eight (48) hours after the result of analysis has been prepared, attaching to the said notice the request for analysis including relevant information provided by the laboratory’s clients to aid the conduct of investigation. Such information provided by the accredited laboratory shall be accorded utmost confidentiality until the commencement of administrative action against the company producing or distributing the health product in question.
4. An accredited laboratory shall inform the FDA in writing of any change in its DTI – PAB accreditation.

 

VII. SEPARABILITY CLAUSE

 

The provisions of this Circular are hereby declared separable and in the event of any such provision/s is/are declared invalid or unenforceable, the validity of enforceability of the remaining portions or provisions which are not affected, shall remain in full force and in effect.

VII.     REPEALING CLAUSE

Provisions of FDA Order No. 2012-001 and all other issuances which are inconsistent to those reflected hereon are modified and/or repealed accordingly. In case any part, term or provision of this Circular is declared contrary to law or unconstitutional, other provisions which are not affected remain in force and effect.

VIII.    EFFECTIVITY

 

This Circular shall take effect fifteen (15) days after its publication in the Official Gazette or in any newspaper of general circulation and upon filing with the University of the Philippines Law Center, Office of the National Administration Register.