Republic of the Philippines

DEPARTMENT OF AGRICULTURE

Office of the Secretary

Elliptical Road, Diliman, Quezon City 1100

Philippines

 

 

ADMINISTRATIVE ORDER

No. __24__

Series of 2005

 

 

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

 

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

I. PURPOSE AND SCOPE

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

Applicants will have to provide documentations ion all laboratory activities and must allow inspection of the 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

When used in the 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 inspection/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. Accomplished Application Form for laboratory inspection/accreditation 2. The laboratory shall be legally identifiable.
  2. The owner of the laboratory whether an individual, partnership or corporation must be registered with the Department of Trade and Industry (DTI) or Securities and Exchange Commission (SEC).
  3. The laboratory shall submit certified photocopy of the environmental certificate of compliance/clearance from DENR.
  4. The laboratory shall submit certified photocopy of the license/s, permit/s from other government regulatory bodies.
  5. The laboratory shall submit a clear structure of responsibility. It shall have:

    a.   Management Staff with authority to discharge duties

    b.   Technical Staff responsible for production and for results

    c.   Quality Control Staff responsible for quality control system of production and of analysis

     

  6. The laboratory shall have the competence to conduct all claimed analyses and assays and 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 Chemists’ 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)

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

    a. Laboratory Inspection Fee ………………………................................ P 250.00

    b. Feed Laboratory Accreditation Fee …………. .. ................................... 500.00

    c. Combination of Feed and VDAP Laboratory Accreditation Fee …. .1,000.00

    d. Service Laboratories ……………………………. ................................1,500.00

IV. COMPLAINTS

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

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

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.

 

 

(Sgd.)  DOMINGO F. PANGANIBAN

                       Secretary

 

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