BAI LETTER CIRCULAR NO. 03, S. 2012, January 30, 2012

[ BAI LETTER CIRCULAR NO. 03, S. 2012, January 30, 2012 ]

SUBMISSION OF LOCAL CERTIFICATE OF ANALYSIS AS A REQUIREMENT FOR REGISTRATION OF VETERINARY DRUG AND PRODUCTS

Adopted: 30 January 2012 Date Filed: 10 February 2012

In order to properly comply with the requirement on the registration of Veterinary Drug and Products (VDAP) specifically on the submission of Certificate of Analysis (CA), the following must be followed:

Certificate of Analysis from BAI or BAI Recognized Laboratories must always be submitted.

Where the analysis/assay for the Veterinary Drug and Products are not being conducted by BAI or any of its recognized laboratories then the assay from the manufacturer can be accepted.

The Certificate of Analysis of the finished product shall include the results of all the requirements and test methods stated in the technical/quality specifications of the products.

The certificate, validated and certified shall:

Refer to the same batch/lot number of the samples submitted for the analyses

Be on the letterhead or other paper that adequately identifies the manufacturer of the product.

Be dated with the date of the analyses and signed by a company officer over his/her printed name.

State the specifications and methods against which and by which the tests are performed

Give the test result (all tests and analyses that involve measurement shall be reported as the actual numerical results, not description like “complies” or “pass”)

Signed photocopies of such documents are acceptable as is a computer generated document meeting the above requirement.

For compliance.

(SGD.) EFREN C. NUESTRO, DVM CESO III Director IV