Title
Accreditation Guidelines for Quality Control Labs
Law
Bai Administrative Order No. 24
Decision Date
Jul 18, 2005
This administrative order establishes comprehensive guidelines and requirements for the accreditation of quality control laboratories involved in commercial and non-commercial feed and veterinary drug manufacturing, ensuring compliance with regulatory standards and promoting accountability in laboratory practices.
A

Questions (BAI ADMINISTRATIVE ORDER NO. 24)

It sets general guidelines and requirements for the accreditation of quality control laboratories of commercial/non-commercial feed manufacturers, veterinary drug manufacturers/tollers, and purely service laboratories. Applicants must document laboratory activities and allow inspection by Bureau of Animal Industry (BAI) assessors from CAFAL-LSD.

Accreditation is the formal recognition of a laboratory’s competence.

Assessors are technical staff from BAI’s Central Animal Feed Analysis and Pharmaceutical Production Laboratories. They conduct inspections/audits and provide recommendations.

It is a periodic and systematic assessment of all policies and procedures of the laboratory.

Test procedures are defined technical procedures of all analyses/assays conducted by the laboratory.

Documentation refers to written procedures and/or results.

They provide essential traceability used to demonstrate accuracy of methods/results, monitor performance to validate methods, and enable comparison of methods against set standards.

The owner (individual, partnership, or corporation) must be registered with the Department of Trade and Industry (DTI) or the Securities and Exchange Commission (SEC).

A certified photocopy of the environmental certificate of compliance/clearance from DENR.

Certified photocopies of its licenses/permits from other government regulatory bodies.

A clear structure of responsibility with: (a) managerial staff with authority to discharge duties; (b) technical staff responsible for production and results; and (c) quality control staff responsible for the quality control system of production and analysis.

It must have the competence to conduct all claimed analyses/assays and deliver results within a prescribed period with traceability.

The laboratory must submit documented analysis procedures.

The laboratory must submit: (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; (g) list of equipment with specifications; (h) list of chemicals and reagents with number of bottles and net weight; (i) prescribed fees (if any); (j) list of reference books/materials; (k) floor plan of the laboratory; and additional requirements for ocular inspection and evaluation.

It must request in writing the schedule for laboratory inspection, convey the inspector(s) to and from the site, and submit receipt(s) of payment for inspection and accreditation fees.

Yes. Per annum: Laboratory Inspection Fee = PHP 250; Feed Laboratory Accreditation Fee = PHP 500; VDAP Laboratory Accreditation Fee = PHP 1,000; Combination of Feed and VDAP = PHP 1,500; Service Laboratories = PHP 1,500.

It must have documented policies and procedures for resolving client complaints and maintain complete records of complaints and actions taken.

Accreditation is valid for one (1) year.

The Laboratory Services Division, Bureau of Animal Industry.

It takes effect immediately upon issuance/adoption (Adopted 18 July 2005).


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