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New Batch Notification Form
FDA notification form for new batch of laboratory
Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: Republic of the Philippines
Republic of the Philippines
Department of Health
Department of Health
Food and Drug Administration
Food and Drug Administration
Civic Drive, Filinvest City, Alabang, Muntinlupa City
Civic Drive, Filinvest City, Alabang, Muntinlupa City
ASSESSMENT SLIP
ASSESSMENT SLIP
Date:
0-Jan-00
Date:
Expiry Date:
0-Jan-00
No. of Samples:
0
Company Name: 0
Company Name: 0
Product Information
Product Name:
0-Jan-00
Product Information
Expiry Date:
0
/
Batch / Lot Number:
0-Jan-00
No. of Samples:
Product Name:
0
/
Batch / Lot Number:
Type of Request:
Certificate/ Evaluation
Type of Request:
Amendment
X Batch Notification
Certificate/ Evaluation
Amendment
X Batch Notification
Others
Others
Lot Release Certificate (Vaccine)
Lot Release Certificate (Vaccine)
LGU Purchases
LGU Purchases
Purchase
Purchase
Analysis Requested:
Analysis Requested:
Visual Examination
Aerobic Plate Count
Visual Examination
Aerobic Plate Count
Dissolution
Coliform/E.Coli (MPN)
Dissolution
Coliform/E.Coli (MPN)
pH
Yeast and Molds
pH
Yeast and Molds
Identification Test
Presumptive Test (Salmonella)
Identification Test
Presumptive Test (Salmonella)
Tablet Hardness
Staphylococcus Aureus Count
Tablet Hardness
Staphylococcus Aureus Count
Sterility Test
Heavy Metals
Sterility Test
Heavy Metals
Baterial Endotoxin Test (LAL)
Vitamins
Baterial Endotoxin Test (LAL)
Vitamins
Assay/Potency (Single Component)
Others:
Assay/Potency (Single Component)
Others:
Assay/Potency (Multi Component)
Assay/Potency (Multi Component)
Assessed by:
Assessed by:
Payment Details
Amount:
OR Number:
Date:
Payment Details
Amount:
OR Number:
Date:
Date Effective: 10 March 2014
Issued by: Records Management Team
Form No: QSP(SOP)3.10-02Annex2
Page 1 of 1
Date Effective: 10 March 2014
Issued by: Records Management Team
Form No: QSP(SOP)3.10-02Annex2
Page 1 of 1
ANTIBIOTIC DRUG PRODUCT BATCH NOTIFICATION
BATCH NOTIFICATION NUMBER
TO BE FILLED UP BY FDA OFFICIAL
Assessed and
Received by
Date:
Date
PAYMENT INFORMATION
THE DIRECTOR GENERAL
Food and Drug Administration
Civic Drive, Filinvest City, Alabang 1781
Muntinlupa, Philippines
ATTENTION: COMMON SERVICES LABORATORY
Amount Php
OR Number
Date
Sir/Madam:
In accordance with Administrative Order No. 2008-0033, we wish to apply and notify the FDA of our intention to have our batch of antibiotic product,
more particularly described below, exempted from the required batch notification
PRODUCT PARTICULARS
Generic Name/s
:
Brand Name
:
Dosage Strength
:
Dosage Form
:
Route of Administration
Batch Number
:
Lot Number :
:
Manufacturing Date :
Expiration Date
:
FDA Registration No.
:
CPR Validity
:
Batch Size
:
Theoretical Yield in Number of Units :
Actual Yield/Volume of Importation in
Number of Units (as indicated in the
commercial invoice) :
Packaging Type
:
Presentation or Pack Size :
COMPANY PARTICULAR
Manufacturer's Name
LTO Number
LTO Validity
Trader's Name
LTO Number
LTO Validity
Importer's Name
LTO Number
LTO Validity
Distributor's Name
LTO Number
LTO Validity
Repacker's Name
LTO Number
LTO Validity
Others (Packed by; Packed For; Marketed By; Marketed For; Repacked for)
LTO Number
LTO Validity
Form Number: QSP (SOP) 3.8-01 Annex 5
Issued by: Records Management Team
Date Effective: 19 October 2017 Revision Number 08
Page 1 of 3
DECLARATION
In support of our exemption from batch certification, I, the undersigned, hereby declare under oath that:
1. I am duly authorized to bind the establishment I represent pursuant to the authority attached to this Notification form (Board
Resolution in case of corporation and Special Power of Attorney in all other cases both of which should be duly notarized);
2. In behalf of my company, the antibiotic drug product identified in the notification meets all the legal requirements, and
conforms to all existing standards and specification requirement applicable to the above product subject of exemption.
3. I declare that the particulars given in this notification are true and all data and information of relevance in relation to the
exemption have been supplied, as well as, the documents attached herein are authentic or true copies.
4. I agree that the acceptance and signing of this Notification shall not constitute as an agreement by FDA in anyway, that the
particular batch of the antibiotic drug product produced or imported meets all other pertinent regulatory requirements, such as
but not limited to, the product’s conformance to its registered specification or approved labelling.
5. I agree that the grant of exemption shall be automatically revoked by the FDA in the event that there is subsequent findings of
misrepresentation in any of the data indicated in the required documents or any of the said documents is subsequently found to
be falsified or fraudulently filed; and/or in case the samples belonging to the same batch or batches of antibiotic drug product/s
collected through post monitoring surveillance shall be found not to conform to the product’s registered specification or
approved labeling.
6. The company I represent shall automatically cease and desist from further distributing the batch or batches of the antibiotic
product subject of revocation upon receipt of the notice of revocation and pending any administrative proceeding until further
notice of the FDA.
7. I or my company undertake to:
i.
Ensure that the product’s technical and safety information is made readily available to the Food and
Administration (FDA) anytime when requested, and to keep records of the distribution of the products for
product recall purposes;
ii.
Notify the FDA as soon as possible by telephone, facsimile transmission, email or in writing, and in any case,
no later than 7 calendar days after first knowledge of any fatal or life threatening serious adverse event if the
cause, whether proximate or otherwise, of such adverse events is the use of the antibiotic product subject of
the exemption;
iii.
Report to the FDA of all other serious adverse events that are not fatal or life threatening as soon as possible,
and in any case, no later than 15 calendar days after first knowledge, using the Adverse Drug Event Report
Form if the cause, whether proximate or otherwise, of such adverse events is the use of the antibiotic product
subject of the exemption;
Keep or hold FDA free and harmless against any and all third party claims arising from the above adverse
iv.
events or from the exemption of the subject antibiotic product; and
v.
Respond to and cooperate fully with the Food-Drug Regulatory Officers with regard to any subsequent postmarketing activity initiated by the FDA.
8. I understand that our company or establishment cannot place reliance on the acceptance of our antibiotic drug product
notification by the FDA in any legal proceeding concerning the above product, in the event that said product has failed to
conform to any of the standards or specifications previously declared to the FDA.
Form Number: QSP (SOP) 3.8-01 Annex 5
Issued by: Records Management Team
Date Effective: 19 October 2017 Revision Number 08
Page 2 of 3
COMPANY PHARMACIST
Company Name
Signature
Printed Name
Position/Designation
Email Address
Contact Number
Date
:
:
:
:
:
:
:
ACKNOWLEDGEMENT
SUBSCRIBED AND SWORN TO BEFORE ME this __________________________________
personally appeared the following:
Name
Residence Certificate
Date Issued
Place Issued
Known to me and to me known to be the same persons who executed the foregoing instrument and they
acknowledged to me that the same is their free and voluntary act and deed.
WITNESS MY HAND AND SEAL on the date and place first above written
Doc No.
Page No.
Book No.
Series of
Form Number: QSP (SOP) 3.8-01 Annex 5
Issued by: Records Management Team
Date Effective: 19 October 2017 Revision Number 08
Page 3 of 3
DATE
00 January 1900
BATCH NOTIFICATION
NUMBER
GENERIC NAME
0
OTHERS
0
BRAND NAME
0
DOSAGE STRENGTH
0
DOSAGE FORM
0
ROUTE OF
ADMINISTRATION
0
BATCH NUMBER
MANUFACTURING
DATE
LOT NUMBER
0
EXPIRATION DATE
0
REGISTRATION
NUMBER
CPR VALIDITY
00 January 1900
BATCH SIZE
0
Theoretical Yield in
Number of Units
0
Actual Yield/Volumne of
Importation in Number of
Units (as indicated in the
commercial invoice)
0
Packaging Type
Presentation or Pack
Size
Manufacturer's Name
0
LTO Number
LTO Validity
00 January 1900
Trader's Name
0
LTO Number
LTO Validity
00 January 1900
Importer's Name
0
LTO Number
LTO Validity
00 January 1900
Distributor's Name
0
LTO Number
LTO Validity
00 January 1900
Repacker's Name
0
LTO Number
LTO Validity
00 January 1900
Others (Packed by; Packed
For; Marketed By; Marketed For;
Repacked for)
0
LTO Number
LTO Validity
00 January 1900
Company Name
0
Printed Name
0
Position/Designation
0
Email Address
0
Contact Number
0
Date
00 January 1900
Assessed and
Received by
DATE
00 January 1900
OR NUMBER
0
AMOUNT
50.00
DATE
00 January 1900
