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