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Self-Assessment Tool Kit for Lot Release Certification

FDA assessment tool kit for lot release certification

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
Self-Assessment Tool Kit for Lot Release Certification
General instructions during submission of applications:
Submissions shall be suitably bound (not stapled nor clipped) and placed in a plastic envelope.
The second page shall contain the table of contents of the application.
An authorized English translation shall accompany any material not issued in English.
Each document submitted should have an accompanying tab or mark for easy identification and location.
All documents should be arranged logically according to this tool-kit.

FDA Registered Product Name
Dosage Strength/ Form
Brand Name
Lot/Batch No.

DOCUMENTS

:
:
:
:

______________________________________________________________
______________________________________________________________
______________________________________________________________
______________________________________________________________

NO. OF
UNITS/
SETS/COPIES
TO BE
SUBMITTED

REQUIREMENTS
(Pls. check)

REMARKS/
FINDINGS
Y N NA

A. GENERAL REQUIREMENTS
Original

Certificate of Product

2

2

Registration (CPR)

  

Duly accomplished, accurate and signed

  
  

Valid at the time of application

Lot Release
Application Form

2.

Signatory is an authorized representative

Duly accomplished, accurate and signed

1.

  

  

Name of manufacturer, trader, importer, distributor
same as reflected in LTO, if not, must have
amendment

  

Validity at the time of application

3.

License to Operate
(LTO)

Manufacturer

  

Trader

  

Importer

  

Distributor

1

  

Summary Lot Protocol/
In- process control and
testing results (in the
absence of summary lot
protocol)

  

Original/ Certified True Copy
Flow diagram

1

SLP Template (Hard and soft copy)
*One-time submission only

  

Batch Numbering System

4.

  

Date Effective: 10 February 2017
Authorized by: Records Management Team

1

  

Duly signed and dated bearing the same lot/
batch number as the sample submitted

  
  

No evidence of tampering / alteration of

Certificate of Analysis
(CA) of Finished
Product and Diluent (if
applicable)

Original/ Certified True Copy

With complete test results

5.

  

Form No.: QWP-CSL-1-294 ANNEX 3
Title of Form: Title of Form: Self-Assessment Checklist for LRC

Revision No: 00
Page No: Page 1 of 3

Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
DOCUMENTS

NO. OF
UNITS/
SETS/COPIES
TO BE
SUBMITTED

REQUIREMENTS
(Pls. check)

REMARKS/
FINDINGS
Y N NA

information(erasures countersigned by an
authorized signatory)

6.

7.

NRA/NCL
Batch
Release Certificate
(In case of batch
release exemption,
letter of exemption
from the NRA/ NCL or
state article indicating
the product is batch
release exempted)

Original/ Certified True Copy

1

Representative Sample

  

Lot/batch no. and expiration date indicated
same as on the representative sample

  

In commercial presentation with batch/lot number
the same as that of the submitted CA of the
finished product

3

  

Lot/batch no. and expiry date indicated on the
  
representative sample same as on the application form
Submitted in appropriate storage condition

1

  

SOP for Sampling Method (SOP from license holder
that will provide evidence that random sampling
was conducted for samples that will be submitted
for visual inspection)

  

Primary label
Detached labeling
materials and product
insert

  

Diluent

3

Secondary label

  

Product Insert

8.

  

  

Compliant to Generic Labeling Requirement AO 55s

9.

Packing List / Invoice/
Airway bill

Generic Labeling Exemption
(if applicable)

  

Consistent with the number of units indicated
on the application form

1

  

  

1

Date Effective: 10 February 2017
Authorized by: Records Management Team

Form No.: QWP-CSL-1-294 ANNEX 3
Title of Form: Self-Assessment Checklist for LRC

Revision No: 00
Page No: Page 2 of 3

Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

NO. OF
UNITS/
SETS/COPIES
TO BE
SUBMITTED
B. ADDITIONAL REQUIREMENTS
For Donated Vaccines/ Biological
Products
DOCUMENTS

1.

Identification of
Medical Officer who
will be responsible for
prompt reporting of
any ADR/AEFI ,
among others, to FDA

2.

REQUIREMENTS
(Pls. check)

REMARKS/
FINDINGS
Y N NA

Resume of Medical Officer

  

Report /
Recommendation of
the RFOO on the
inspection of the actual
shipment

  

1

  

For
Governement
procured
products (EPI and non-EPI’s)
1.

Purchase Order and or
Notice of Award from
the Dept. of Health

Assessed by: ___________________________

 Accepted  Denied

Date: ___________________________

Date Effective: 10 February 2017
Authorized by: Records Management Team

Form No.: QWP-CSL-1-294 ANNEX 3
Title of Form: Title of Form: Self-Assessment Checklist for LRC

Revision No: 00
Page No: Page 3 of 3
 
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