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(NAR) VOL. 16 NO. 4 / OCTOBER - DECEMBER 2005

[ BAI ADMINISTRATIVE ORDER NO. 29, S. 2005, September 30, 2005 ]

AMENDED GENERAL GUIDELINES AND REQUIREMENTS ON THE QUALITY CONTROL LABORATORY ACCREDITATION OF COMMERCIAL AND NON-COMMERCIAL FEED MANUFACTURERS, VETERINARY DRUG MANUFACTURERS AND FEED AND DRUG SERVICE LABORATORIES



Pursuant to the implementation of and in support to R.A. 1556; Bureau of Animal Industry A.O. No. 35, Article IV Sections 9 and 11; and A.O. No. 25 Series of 1991, the following requirements for accreditation are hereby promulgated.

I. PURPOSE AND SCOPE

These requirements are to be complied by all Quality Control Laboratories of Commercial/Non-Commercial Feed Manufacturers, Veterinary Drug Manufacturers/Tollers and Purely Service Laboratories.

Applicants shall provide documentations in all laboratory activities and must allow inspection of their laboratory premises by the Laboratory Technical Assessors from the Central Animal Feed Analysis and the Pharmaceutical Production Laboratories of the Laboratory Services Division, Bureau of Animal Industry.

II. DEFINITION OF TERMS

As used in this guidelines, the following terms shall mean as follows:

    1. Accreditation - formal recognition of competence.

    2. Assessors - Technical Staff of the Central Animal Feed Analysis and the Pharmaceutical Production Laboratories of the Bureau of Animal Industry to carry out inspections/audits and shall provide recommendations.

    3. Audit/Inspection - periodic and systematic assessment of all policies and procedures.

    4. Test Procedures - defined technical procedures of all analyses/assays conducted.

    5. Documentation - written procedures/results.

    6. Reference Books/Materials - references which provide essential traceability and are used to demonstrate the accuracy of the following: procedures/methods, results, monitor performance to validate methods and enable comparison of methods by the set standards.

III. REQUIREMENTS:

    1. The laboratory, whether an individual, partnership or corporation, must submit an accomplished Application Form for Laboratory inspection/accreditation.

    2. The laboratory must submit its registration with the Department of Trade and Industry (DTI) or Security and Exchange Commission (SEC).

    3. The laboratory shall submit certified photocopy of the environmental certificate of compliance/clearance from the DENR.

    4. The laboratory shall submit certified photocopy of the license/s, permit/s from other government regulatory bodies (e.g. business permits from Office of the Mayor, etc.)

    5. The laboratory shall submit its list of:

      a. Managerial Staff responsible for operations;
      b. Technical Staff for production and for results; and
      c. Quality Control Staff responsible for quality control system of production and of analysis.

    6. The laboratory shall execute a sworn affidavit that it has the competence to conduct all claimed analyses and assays and can deliver results within a prescribed period with traceability.

    7. The laboratory shall submit documented analysis procedures.

    8. The laboratory shall submit the following documents to CAFAL-LSD for tabletop evaluation:

      a. Duly accomplished and notarized application
      b. Organizational structure
      c. Photocopy of Chemist's PRC license
      d. Affidavit of Quality Control Chemist
      e. List of laboratory analyses conducted
      f. Test procedures of all analyses/capabilities conducted
      g. List of equipment with specifications (classifying into functional and non-functional)
      h. List of chemicals and reagents (no. of bottles, net weight)
      i. Prescribed fees (if any)
      j. List of reference books/materials
      k. Floor plan of the laboratory
      l. Ocular inspection and evaluation of laboratory facilities

        i. It shall request in writing the schedule for laboratory inspection
        ii. It shall convey inspector(s) to and from the site
        iii. It shall submit receipt of payment/s (inspection and accreditation fees).

    9. The laboratory shall pay the following corresponding fees per annum:

      a. Laboratory Inspection Fee --------------------------- P250.00
      b. Feed Laboratory Accreditation Fee ------------------- 500.00
      c. VDAP Laboratory Accreditation Fee ---------------- 1,000.00
      d. Combination of Feed and VDAP Laboratory
      Accreditation Fee ---------------------------------------- 1,500.00
      e. Service Laboratories --------------------------------- 1,500.00

IV. COMPLAINTS

The laboratory shall have documented policy and procedures for resolution of complaints received from clients.

The laboratory shall keep complete records of all complaints and of all the actions taken thereon.

V. VALIDITY

Accreditation shall be valid for a period of one (1) year.

The implementation of this ORDER shall be the responsibility of the Laboratory Services Division, Bureau of Animal Industry.

This ORDER shall take effect immediately.

VI. FUNDING SUPPORT

Funding requirement in the implementation of this Administrative Order shall be drawn from the proceeds of various fees as indicated in number 9 of this Administrative Order, deposited under the Philippine Livestock Promotion Fund (RA 1578).

VII. REPEALING CLAUSE

All Administrative Orders, Rules and Regulations and other Administrative Issuance or parts thereof inconsistent with this Administrative Order are hereby repealed or modified accordingly.

Adopted: 30 Sept. 2005

(SGD.) DOMINGO F. PANGANIBAN
Secretary

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