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Initial Application of LTO

FDA LTO initial application form for drug manufacturer

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG REGULATION AND RESEARCH
DRUG MANUFACTURER (

) / PACKER (

) / REPACKER (

) TRADER (

)

SELF-ASSESSMENT TOOLKIT FORM
INITIAL APPLICATION OF LICENSE TO OPERATE

COMPANY NAME
:
COMPANY ADDRESS
:
OWNER
:
Directions:
Fill out the form by ticking the applicable box. Provide remarks on the client’s column when necessary.
Submit in Portable Document Format (pdf) and word format duly signed by the pharmacist/owner.

DOCUMENTARY REQUIREMENTS:


Yes

No

REMARKS
CLIENT

FDA

1. Application Form
Is the integrated application form properly filled out?




Is it duly notarized?
Are the signatories in the application form the pharmacist
and authorized persons as required under the following
circumstances?
(a) If single proprietorship – the owner as registered in
DTI (unless there is a different authorized person)
(b) If partnership/corporation – one of the incorporators or
authorized person as indicated in the board resolution
or Secretary’s Certificate
(c) If cooperative – authorized person indicated in the
board resolution or Secretary’s Certificate of the
cooperative
If the signatory is not the owner or one of the incorporators, as
the case may be:

Is there a board resolution or notarized Secretary’s
Certificate clearly identifying the person authorized to sign
for and in behalf of the owner or corporation submitted?








2. Proof of Business Name Registration
(a) For single proprietorship, Certificate of Business
Registration issued by the Department of Trade and
Industry (DTI)
Is the business name applied for LTO the same with that of
DTI registration certificate?
Is the DTI certificate still valid?
Is the owner appearing in the application form the same with
that of the DTI certificate?
Is the address of the establishment applying for LTO within
the territorial coverage? If the business address indicated in
DTI is different from the exact address as declared in the
application form, is there a clear copy of Business/Mayor’s
Permit or Barangay clearance indicating the complete
address of drug establishment?
(b) For corporation, partnership and other juridical person,
Certificate of Registration issued by the Securities and
Exchange Commission (SEC) and Articles of
Incorporation
Is the business name applied for LTO the same with that of
the SEC registration certificate? If the company uses another

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business name style different from its corporate name, is an
amended SEC registration reflecting the same submitted?
 Is the address indicated in the SEC the same with the address
of the establishment applied for LTO?
o If the address in SEC is still occupied but the
business operation applied for LTO is located
in a separate area, is a clear scanned copy of
Business/Mayor’s Permit or Barangay
clearance indicating the complete address of
drug establishment submitted?
o If the address in SEC is no longer occupied, is
an amended SEC registration reflecting the
current business address submitted?
 Is the type of activity and product applied for LTO indicated
in the Articles of Incorporation (Article II)?
(c) For cooperative, Certificate of Registration issued by
the Cooperative Development Authority and the
approved by-laws
 Is the business name applied for LTO the same with that of
the CDA registration certificate?
 Is the address indicated in the CDA the same with the
address of the establishment applied for LTO?
 Is the type of activity and product applied for LTO indicated
in the approved articles and by-laws of the cooperative?
(d) For government-owned or controlled corporation
 Is there a copy of the law creating the same? (if with original
charter)
3. Credentials of Pharmacist
 Is the responsible pharmacist identified?
Identify the name under client’s remarks:
 Is the PRC ID of the pharmacist still valid?
 If the PRC is not valid, is there a proof of renewal attached?
 Is the resignation letter of the responsible pharmacist from
previous company signed/ conformed by the
owner/authorized representative of the establishment?
(where applicable)
 Is the LTO number of the previous company indicated?
 Is the name of pharmacist in the certificate of attendance to
FDA seminar on licensing of establishment the same with
application form for LTO?
 Is the seminar attended corresponds to the type of LTO
applied by the establishment?
 If not yet attended, is any proof of confirmation issued by the
FDA Academy of the scheduled licensing seminar included?
 If applying for pharmacist exemption, is the letter indicating
the pharmacist’s duties and responsibilities as well as the
schedule and hours of supervision signed both by the said
pharmacist and the owner/ authorized representative of the
establishment?
4. Risk Management Plan
 Are the risks for the establishment properly identified?
 Are there plans of action for these identified risks?
 Is there an established SOP for pharmacovigilance?
 Is there an established SOP for handling regulatory
mandates from FDA, such as product recall, withdrawal,
suspension of activities, etc?
 Note: While the official RMP framework from FDA is not yet
issued, a commitment letter must be submitted.

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5. Location Plan
 Is the sketch submitted indicates certain landmark?
 Is the GPS Coordinates included?
6. Site Master File
 Are the relevant sections identified in PIC/s GMP included in
the submitted SMF?
 Is the SMF signed by the authorized personnel?
 Is the SMF submitted the valid/latest revision?
 Is the submitted SMF compliant to PIC/s GMP?
7. Proof of Payment
 Is the payment made according to the required fee?
 Is there a scanned copy of proof of payment (e.g FDA official
receipt, Landbank On-coll validated slip) submitted?
NOTE: ADDITIONAL DOCUMENTS MAY BE REQUIRED TO BE SUBMITTED AS DEEMED NECESSARY.

ADDITIONAL REQUIREMENTS
(ON-SITE INSPECTION ONLY):
1. Quality Management System
2. Quality Manual and Standard Operating Procedures
(a) Receipt and Dispatch
 Is there an orderly and secure system of filling up to date invoices from suppliers and buyers identifying lot numbers
or batch numbers of manufacturers stock pursuant to FDA Memo Circular No. 001 s. 1983? Is there a product description,
expiry date and transport temperature?
(b) Sampling Procedures
(c) Handling of consumer complaints, recalls, and other regulatory mandates
 Does the company maintain registry of complaint with action?
(d) Disposal of expired/deteriorated/ damaged and returned products
(e) Cleaning of Storage Area
 Is there a regular conduct of pest control?
(f) Other SOPs as required
3. Contract Agreement
(a) Contract manufacturing agreement for Drug Manufacturer:
If with contract manufacturing activity:
 Is the contract manufacturing agreement between Drug Manufacturer (Contract Acceptor) and Manufacturer-Trader
(Contract Giver) valid and notarized? (with attached ANNEX A for the list of products indicating the generic name,
dosage strength, dosage form, and if applicable, brand name, product registration number and its validity)
 Is it clearly stated that the contract given is the owner of product formulations and its corresponding product
registration?
 Is there a stipulation of responsibilities of both parties for the quality of products? If not indicated, is there a separate
Quality Agreement signed by the contracting parties?
(b) Contract packing agreement for Drug Manufacturer-Packer:
For products packed and registered under the name of the Manufacturer-Packer:
 Is the contract packing agreement between Drug Manufacturer-Packer and FDA licensed Supplier valid and
notarized? (with attached ANNEX A for the list of products indicating the generic name, dosage strength, dosage form,
and if applicable, brand name, product registration number and its validity)
 Is there a stipulation of responsibilities of both parties for the quality of products in the contract? If not indicated, is
there a separate Quality Agreement signed by the contracting parties?
If engaged in contract packing activity with other Drug Manufacturer or Drug Manufacturer-Trader:
 Is there an agreement between the parties involved? Is it valid and duly notarized?
 Is there a stipulation of responsibilities of both parties for the quality of products in the contract? If not indicated, is
there a separate Quality Agreement signed by the contracting parties?
(c) Contract repacking agreement for Drug Manufacturer-Repacker:
For products repacked and registered under the name of the Manufacturer-Repacker:
 Is the repacking agreement between Drug Manufacturer-Repacker and FDA licensed Supplier valid and notarized?
(with attached ANNEX A for the list of products indicating the generic name, dosage strength, dosage form, and if

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applicable, brand name, product registration number and its validity)
Is there a stipulation of responsibilities of both parties for the quality of products? If not indicated, is there a separate
Quality Agreement signed by the contracting parties involved? Is it valid and duly notarized?

If engaged in contract repacking activity with other Drug Manufacturer and Drug Manufacturer-Packer or Drug
Manufacturer-Trader or Distributor/Importer/Wholesaler?
 Is there an agreement between the parties involved?
 Is it valid and duly notarized?
 Is there a stipulation of responsibilities of both parties for the quality of products in the contract? If not indicated, is
there a separate Quality Agreement signed by the contracting parties?

4. Qualification and Validation Documents (if applicable)
5. Master and Batch Production Records (if applicable)
(a)
(b)
(c)
(d)
(e)
(f)

Manufacturing Formula
Processing Operations
Packaging Instructions
Batch Processing Records
Batch Packaging Records
Other records, as required

6. Technical Specifications (if applicable)
(a)
(b)
(c)
(d)

Specifications for starting and packaging materials
Specifications for intermediate and bulk products
Specifications for finished products
Other specifications, as required

7. Credentials of other qualified personnel (e.g., production manager, quality assurance manager, quality control
manager, authorized person for batch release, pharmacovigilance officer, if applicable)
(a) Curriculum vitae
(b) Updated training records
(c) Other credentials, as required

8. Proof of Ownership/Lease Agreement of the space/building
 If owned, is there a valid document showing proof of ownership of the space/bldg. occupied?
 If under lease, is there a valid and notarized contract of lease or certificate of occupancy?
9. Reference Materials (Hard copy or e-copy)
(a)
(b)
(c)
(d)

R.A. 3720, R.A 9711, R.A. 6675, R.A. 5921, R.A. 8203, R.A. 9502
PIC/s Guide Part I & II and its Annexes (latest version)
Standard Practice Guidelines
Other applicable reference materials

10. Other procedures protocols, records, and reports as required by PIC/s-GMP
Prepared by:
Position (Pharmacist / Owner):
Decision:
Approval
Denial

--- To be filled out by client: --Signature:
Date:
--- To be filled out by RFO: ---

Remarks:

Clarification

Inspection

Evaluated by:

Decision:
Approval
Clarification

Date:

Remarks:

--- To be filled out by CDRR: ---

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Evaluated by:

Date:

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