(NAR) VOL. 26 NO. 2/ APRIL - JUNE 2015
1) | Method of medical gas manufacturing (e.g., concentrator, chemical synthesis, purifier) |
2) | Scale of manufacturing (e.g., small, medium, large) |
3) | Mode of gas delivery (e.g., from cylinders, from a medical gas pipeline system) |
4) | End users of the manufactured medical gas (e.g., inpatients of hospitals and other health facilities, other consumers) |
5) | Type of ownership (e.g., Department of Health (DOH)-retained, Local Government Unit (LGU)-owned, privately-owned] |
1) | Application Form | |
A completely filled-out and notarized application form signed by the pharmacist and owner/authorized representative must be submitted. | ||
2) | Proof of Business Name Registration | |
A valid proof of business name registration must be submitted: | ||
(a) | For single proprietorship - Certificate of Business Registration issued by the Department of Trade and Industry (DTI) | |
(b) | For corporation, partnership and other juridical person – Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation | |
(c) | For cooperative - Certificate of Registration issued by the Cooperative Development Authority and the approved by-laws | |
(d) | For government-owned or controlled corporation - the law highlighting the provision creating such establishment | |
The proof of business name registration must specify the exact and complete address, e.g. unit number, floor, building, lot, block, phase, street, barangay, city/ municipality, province, where applicable. | ||
3) | Credentials of the Pharmacist-in-Charge | |
The credentials of the identified pharmacist-in-charge must be submitted, which include: | ||
(a) | Valid Professional Regulation Commission (PRC) ID | |
(b) | Certificate of Attendance to appropriate FDA Licensing Seminar | |
(c) | Resignation letter of the pharmacist from previous employer (if previously employed) | |
The other qualified personnel shall be listed, which include the (1) hospital engineer or equally qualified person responsible for overseeing the operations of the manufacturing facility and (2) personnel responsible for maintenance. The credentials will not be submitted during application but may be verified during inspection. | ||
4) | Risk Management Plan | |
A general Risk Management Plan (RMP) for the establishment must be submitted. The RMP shall contain details on how to identify, characterize, prevent or minimize risks relating to the medical gas they engage in. These shall include pharmacovigilance activities and interventions of the establishment to manage the risks. | ||
5) | Location Plan | |
A sketch of the location of the establishment must be submitted which shall be used for inspection purposes. This sketch must indicate clear directions with identified landmarks to locate the establishment. | ||
In addition, the Global Positioning System (GPS) Coordinates in decimal degrees (DD) [Latitude and Longitude] must be indicated in the submission. | ||
6) | Site Master File | |
The Site Master File (SMF) must be submitted, in accordance with the latest edition of the Pharmaceutical Inspection Cooperation Scheme (PIGS) - Good Manufacturing Practice (GMP). | ||
7) | Proof of Payment | |
Proof of payment (e.g., official receipt or authorized bank payment slip) must be included as proof of filing of application. | ||
8) | Self-Assessment Toolkit | |
To guide and facilitate the submission, a Self-Assessment Toolkit (SATK) must be submitted, which shall also serve as the worksheet during evaluation of FDA. | ||
The list of documentary requirements for initial and renewal applications of LTO, reissuance of lost or destroyed LTO, as well as voluntary cancellation of LTO is attached as Annex A[*]. |
1) | Desktop Evaluation | |
All applications shall be initially reviewed by the respective FDA Regional Field Offices to determine compliance with the administrative and technical requirements. | ||
The FDA, in the course of its evaluation may require additional or supplemental documents as proof of compliance to the existing regulations. | ||
2) | Pre-opening Inspection | |
After evaluation of the LTO application, the establishment shall be subjected to pre-opening inspection to determine compliance with the existing guidelines on PlC/S-GMP. | ||
In addition to the documentary requirements submitted during application (Section IV, B of this Circular), the following documents related to the manufacturing of medical gas shall be verified during inspection: | ||
• | Quality Management System of the establishment, incorporating the medical gas manufacturing facility; | |
• | Quality Manual and Standard Operating Procedures of the medical gas manufacturing Facility; | |
• | Contract Agreement between the supplier/installer of the medical gas manufacturing machine and the establishment | |
• | Qualification and Validation Documents | |
• | Master and/or Batch Production Records | |
• | Specifications | |
• | Credentials of other qualified personnel | |
• | Relevant reference materials (e.g. Republic Acts, PIC/S-GMP Guide, standard practice guidelines) | |
• | Other procedures, protocols, records, and reports as required by PlC/S- GMP | |
The abovementioned additional documents will serve as proof of compliance by the establishment with the existing regulations on licensing. | ||
A report shall be issued to the drug establishment after inspection, which shall be the basis for further decision/action of FDA (e.g., approval/ disapproval of an application for LTO, and/or for such other purposes). | ||
3) | Post-licensing Inspection | |
All establishments with approved LTO shall be subjected to routine inspection for their compliance to GMP and other relevant and applicable practices. In addition, major variation applications may require post-licensing inspection prior to the approval of such variation. Establishments which are subject to regulatory action due to different triggers (e.g., violation of any of the provisions of FDA laws, rules and regulations, and any other laws related thereto, occurrence of adverse drug reactions, as well as other quality, safety, and/or efficacy issues) shall also be inspected. |
1) | Major Variation | |
(a) | Change of Ownership | |
(b) | Transfer of Location | |
2) | Minor Variation - Prior Approval (a) Expansion of Establishment (b) Change of Business Name (c) Zonal Change in Address | |
3) | Minor Variation – Notification | |
(a) | Change of Pharmacist-in-Charge or Other Qualified Personnel |
Table 1. Inspection Transition Phasing | ||
Phase | Classification of Hospitals and Other Health Facilities* | |
1 | General Hospital | Level 3 |
2 | Level 2 | |
3 | Level 1 | |
4 | Specialty Hospital | |
Category A | ||
Category B | ||
5 | Other Health Facilities | Category C |
Category D | ||
* as per Administrative Order No. 2012-0012 |