Implementing Guidelines for Administrative Order No. 2013-0022 dated 13 August 2013, Subject: Guidelines for Current Good Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug Manufacturers

I.  RATIONALE

On 13 August 2013, Administrative Order No. 2013-0022 was issued requiring the creation of systems and procedures that would (1) ensure the compliance of all imported sources of pharmaceutical products with current Good Manufacturing Practices (cGMP), and (2) establish a separate database and coding system for applications of, and those compliant to cGMP.

Thus, the issuance of this Circular to clearly define the rules and regulations, the activities that must be undertaken, as well as the identification of the appropriate office that shall be responsible and accountable for the proper implementation of the said regulation's provisions.

II.  OBJECTIVES

Given the rationale stated above, the objectives of this Circular are:
1) To provide supplementary/implementing guidelines to Administrative Order No. 2013-0022;
2) To identify/create the specific units within the FDA, as well as their responsibilities in implementing the said regulation and this issuance; and
3) To establish systems that is aimed to ensure compliance of foreign drug manufacturers with cGMP.

III.  SCOPE

This Circular shall apply to all establishments importing drug, foreign drug manufacturers and concerned Offices of FDA.

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Attachments:
Download this file (FC2014-016.pdf)FC2014-016.pdf

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