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Date: Oct. 10, 2025, 11:45 a.m.

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Date: 2025-10-10 16:17:06.846982

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Date: 2025-10-17 15:11:24.968956

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Guidelines in constructin a drug manufacturing facility

Published by Department of Health(DOH) on Oct. 10, 2025.
Requested from DOH by A. Tan at 11:45 AM on Oct. 10, 2025.
Purpose: Project study regarding a proposed drug manufacturing facility
Tracking no: #DOH-391319308493

A.TAN Oct. 10, 2025, 11:45 a.m.

Good day! I am a fourth year BS Civil Engineering student from The University of Negros Occidental - Recoletos Inc. currently conducting a project study regarding a construction of drug manufacturing facility. In line with this, i am respectfully asking guidance and information regarding the following: - The official standard and guidelines that must be observed in establishing a drug manufacturing facility. -The official layouts and flowcharts of production areas. -The official layouts of warehouse and storage areas. The following information will be of great significance in ensuring that the proposed project will be aligned with the standards of the industry. thank you

A.TAN Oct. 10, 2025, 11:45 a.m.

Good day! I am a fourth year BS Civil Engineering student from The University of Negros Occidental - Recoletos Inc. currently conducting a project study regarding a construction of drug manufacturing facility. In line with this, i am respectfully asking guidance and information regarding the following: - The official standard and guidelines that must be observed in establishing a drug manufacturing facility. -The official layouts and flowcharts of production areas. -The official layouts of warehouse and storage areas. The following information will be of great significance in ensuring that the proposed project will be aligned with the standards of the industry. thank you

F.RECEIVING OFFICER Oct. 10, 2025, 4:17 p.m.

Dear eFOI user,

Thank you for your request made under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.

We have received your request on Guidelines in constructin a drug manufacturing facility. We will respond and process your request on or before Oct. 31, 2025, in compliance with the Executive Order’s implementing rules and regulations.

Please be informed that we have endorsed your request to FOOD AND DRUG ADMINISTRATION for action. We'll send you feedback once available.

Should you have any questions regarding this request, kindly contact me using the reply function on the eFOI portal for request with ticket number #DOH-391319308493.

Further, please be advised that this is a public site, and any information shared in this conversation thread will be visible to the public. Therefore, we kindly request that you refrain from disclosing any sensitive personal information or data in this thread.

Thank you.

Respectfully,

FOI Officer

Department of Health

F.RECEIVING OFFICER Oct. 17, 2025, 3:11 p.m.

Dear eFOI user,

Thank you for your request dated Oct. 10, 2025, made under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.

You have requested the Guidelines for constructing a drug manufacturing facility

Regarding the request for a guideline, FDA inspectors are using the PIC/S GMP guide PE 009-14 as a reference. All drug manufacturers based their layouts and flowcharts of production areas and warehouse/storage areas on the same guide.

Response to #DOH-391319308493 - FOI Receiving Officer - [email protected]

Your right to request a review

If you are dissatisfied with our response to your FOl request, you have the option to request an internal review. To initiate this process, kindly submit your written appeal for review addressed to the Central Appeals and Review Committee (CARC) at [email protected].

Please provide a detailed explanation of your dissatisfaction with our response within 15 calendar days from the date of receiving this response. We will conduct the review and communicate the outcome within 30 calendar days from the receipt of your review request.

Should you remain unsatisfied with the review outcome, you retain the right to appeal to the Office of the President under Administrative Order No. 22 (s. 2011).

Thank you.

Respectfully,

FOI Officer

Department of Health

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