Authority for the officers of Drug Good Manufacturing Practice (GMP) Inspectorate Task Force to conduct inspection and post marketing surveillance in accordance with Republic Act 9711, even beyond office hours, as the need arises in Luzon, Visayas and Mindanao from January to December 2019

FDA PERSONNEL ORDER
No. 2019-0020


SUBJECT: Authority for the officers of Drug Good Manufacturing Practice (GMP) Inspectorate Task Force to conduct inspection and post marketing surveillance in accordance with Republic Act 9711, even beyond office hours, as the need arises in Luzon, Visayas and Mindanao from January to December 2019

 

In enforcing Republic Act No. 3720 as amended by Republic Act No. 9711 and its implementing Rules and Regulations, the Drug GMP Inspectors under the task force created per FDA Order 2018-085 and FPO 2018-0820 are hereby authorized and empowered, among others, to:

 

1) assume primary jurisdiction in inspecting and evaluating domestic or foreign drug manufacturers;
2) monitor, inspect and evaluate drug products and establishments covered by the FDA Act of 2009, its Rules and Regulations, and other relevant laws, for the purpose of the issuance of the necessary authorizations;
3) collect samples of drug products including finished or unfinished materials, containers, and labelling;
4) recommend for issuance of appropriate authorizations or disapproval of an application for a License to Operate or other-related authorization;
5) issue Certificates of Compliance with technical requirements to serve as basis for the issuance of appropriate authorization and spot check for compliance with regulations regarding operation of drug manufacturers;
6) conduct post marketing surveillance of all drug products;
To submit a report to serve as basis for the motu proprio action of the Deputy Director-General for Field Regulatory Operations Office, upon finding, in the course of its evaluation, monitoring, inspection and spot checking, of any non-compliance and violation of other requirements required by the FDA, its implemented laws, Rules and Regulations;
7) To exercise such other powers and perform such other GMP-related functions that may be assigned or necessary to carry out the above duties and responsibilities.

 

To carry out the above functions, powers and duties, the duly designated officers or employees FDA are authorized by the above law to (1) enter, at reasonable hours, any factory, warehouse, or establishment in which drug products are manufactured and/ or held for introduction to the market; and (2) inspect in a reasonable manner, such factory, warehouse, establishment, and all pertinent, finished or unfinished materials, containers, and labelling therein. Such inspection would necessarily include collection of sample, examination of documents relevant to the manufacture of drug products to aid in assessing safety, efficacy, purity, and quality of drug products, and taking copies of documents, pictures, and voice or video recording, whenever necessary, as objective evidence.

 

Pursuant to the above powers, functions, duties, and in the interest of the service, the following Food-Drug Regulation Officers of FROO are hereby authorized and mandated to implement the above functions, duties, and powers over drug manufacturers and drug products, even beyond office hours, as the need arises within Luzon, Visayas and Mindanao. The Licensing Officers may be allowed to perform the above functions subject to the approval of the Deputy Director General of FROO, as the need arises. The foregoing authority shall be valid from 15 January to 15 December 2019:

 

Name

Office

1.      Pia Rose A. Belarmino RFO-NCR
2.      Angeli B. Casala RFO-NCR
3.      Carolyn P. Custodio RFO-NCR
4.      Frances Glorie D. De Luna RFO-NCR
5.      Marissa C. Fajardo RFO-NCR
6.      Mary Angeline V. Francisco RFO-NCR
7.      Michael E. Galang RFO-NCR
8.      Lelian B. Indac RFO-NCR
9.      Jackerwin R. Maur RFO-NCR
10.  Clarissa A. Mendoza RFO-NCR
11.  Cristy Hanna V. Mendoza RFO-NCR
12.  Ma. Lynn Rachelle A. Natividad RFO-NCR
13.  Rioriza A. Ortilano RFO-NCR
14.  Don Bryan A. Orendain RFO-NCR
15.  Raymond L. Sia RFO-NCR
16.  Ma. Suzette R. Sta. Clara RFO-NCR
17.  Rowena K. Velasco RFO-NCR
18.  Maria Lolita B. Abo-ol RFO-NCR
19.  Evadine Astrid M. Pera RFO-I
20.  Janelle L. Lim RFO-II
21.  Mary Christine C. An RFO-V
22.  Edwin E. Castillo, Jr. RFO-V
23.  Ma. Lexia T. Jancorda RFO-VI
24.  Ma. Salome R. Largo RFO-VII
25.  Irish B. Samar RFO-VII
26.  Benczint Benedikt C. Ortega RFO-VIII
27.  Keith Bryan Vincent R. Angeles RFO-IX
28.  Lorelie Joy A. Acha RFO-X
29.  Eba Marie Antonette W. Inis RFO-XI
30.  Mayen P. Abdullah RFO-XII
31.  Lucille Glenda T. Bug-os RFO-XIII

 

Under this Order, these personnel are entitled to avail compensatory time off pursuant to CSC-DBM Joint Circular No. 2 dated 04 October 2004 for services rendered during Saturdays, Sundays and/ or holidays in lieu of overtime pay, provided that they have not incurred any absences tardiness, or undertime during the week (five working days) immediately preceding the weekend and/or holiday they rendered service.

 

Airfare, transportation expenses, van rental, per diem (above 50 kilometres radius from official station), actual and other incidental expenses of the mentioned officers, including accommodation shall be charged against the respective Regional Field Offices funds subject to the usual accounting and auditing rules and regulations.

 

ATTY. EMILIO L. POLIG, JR.
OIC, Deputy Director General
Field Regulatory Operations Office

ATTACHMENTS:

/ In Drugs-GMP / By Mark Alcantara / Comments Off on Authority for the officers of Drug Good Manufacturing Practice (GMP) Inspectorate Task Force to conduct inspection and post marketing surveillance in accordance with Republic Act 9711, even beyond office hours, as the need arises in Luzon, Visayas and Mindanao from January to December 2019
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