Purpose and covered laboratories
- The order establishes general guidelines and requirements for quality control laboratory accreditation.
- The requirements are to be accomplished by all Quality Control Laboratories of:
- Commercial/Non-Commercial Feed Manufacturers;
- Veterinary Drug Manufacturers/Tollers; and
- Purely Service Laboratories for feed and drug functions.
- Applicants must provide documentation in all laboratory activities.
- Applicants must allow inspection of laboratory premises by Laboratory Technical Assessors.
- Inspections/audits are conducted by assessors from the Central Animal Feed Analysis and the Pharmaceutical Production Laboratories of the Laboratory Services Division, Bureau of Animal Industry.
Key definitions used in accreditation
- Accreditation means formal recognition of competence.
- Assessors are Technical Staff of the Central Animal Feed Analysis and the Pharmaceutical Production Laboratories of the Bureau of Animal Industry who carry out inspections/audits and provide recommendations.
- Audit/Inspection means periodic and systematic assessment of all policies and procedures.
- Test Procedures mean defined technical procedures of all analyses/assays conducted.
- Documentation means written procedures/results.
- Reference Books/Materials provide essential traceability and are used to demonstrate:
- the accuracy of procedures/methods,
- performance monitoring to validate methods, and
- comparison of methods against set standards.
Mandatory requirements for applicants
- An applicant must submit an accomplished application form for laboratory inspection/accreditation.
- The laboratory must be legally identifiable.
- The owner of the laboratory—whether individual, partnership, or corporation—must be registered with either the Department of Trade and Industry (DTI) or the Securities and Exchange Commission (SEC).
- The laboratory must submit a certified photocopy of the environmental certificate of compliance/clearance from the DENR.
- The laboratory must submit certified photocopies of its licenses/permits issued by other government regulatory bodies.
- The laboratory must submit a clear structure of responsibility, including:
- Managerial Staff with authority to discharge duties;
- Technical Staff responsible for production and results; and
- Quality Control Staff responsible for the quality control system of production and of analysis.
- The laboratory must demonstrate competence to conduct all claimed analyses and assays, and must deliver results with traceability within a prescribed period.
- The laboratory must submit documented analysis procedures.
Application documents and tabletop evaluation
- The laboratory must submit specific documents to CAFAL-LSD for tabletop evaluation, consisting of:
- A duly accomplished and notarized application;
- Organizational structure;
- Photocopy of Chemist’s PRC license;
- Affidavit of Quality Control Chemist;
- List of laboratory analyses conducted;
- Test procedures for all analyses/capabilities conducted;
- List of equipment with specifications, classified into functional and non-functional;
- List of chemicals and reagents (including number of bottles and net weight);
- Prescribed fees (if any);
- List of reference books/materials;
- Floor plan of the laboratory;
- Ocular inspection and evaluation of laboratory facilities requirements, including:
- requesting in writing the schedule for laboratory inspection;
- conveying the inspector(s) to and from the site; and
- submitting receipt of payment/s for inspection and accreditation fees.
Complaints system requirement
- The laboratory must have documented policy and procedures for resolving complaints received from clients.
- The laboratory must keep complete records of:
- all complaints, and
- all actions taken on those complaints.
Accreditation validity and responsible office
- Accreditation is valid for a period of one (1) year.
- Implementation of the order is the responsibility of the Laboratory Services Division, Bureau of Animal Industry.
Inspection and accreditation fees per annum
- Applicants must pay the following corresponding fees per annum:
- Laboratory Inspection Fee: P 250.00
- Feed Laboratory Accreditation Fee: P 500.00
- VDAP Laboratory Accreditation Fee: P1,000.00
- Combination of Feed and VDAP Laboratory Accreditation Fee: P1,500.00
- Service Laboratories: P1,500.00