Excel Sheet Download 11597 | Batch Notification Application Form Revision N 11

Partial file snippet.
Sheet 1: AS Form

	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
		Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Civic Drive, Filinvest Corporate City
Alabang, City of Muntinlupa
		

		Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Civic Drive, Filinvest Corporate City
Alabang, City of Muntinlupa
		
	
		

		
	
		

		
	
		

		
	
		

		
	
		

		
	
		ASSESSMENT SLIP
		

		ASSESSMENT SLIP
		
	
		

		DTN : 
		Lab No.: 
		

		Date:
		30 December 1899
		

		

		

		DTN : 
		Lab No.: 
		

		Date:
		30 December 1899
		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		 Company Name: 
		0
		

		

		

		 Company Name: 
		0
		

	
	
		

		Product Information
		

		

		

		Product Information
		

	
	
		

		 Product Name:
		List of Generic Names (please use drop down menu)
		 Expiry Date:
		0
		

		

		

		 Product Name:
		List of Generic Names (please use drop down menu)
		 Expiry Date:
		0
		

	
	
		

		 Batch/Lot Number:
		

		/
		

		 No. of Samples:
		

		

		

		 Batch/Lot Number:
		

		/
		

		 No. of Samples:
		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		Type of Request:
		

		Type of Request:
		
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		  Certificate/ Evaluation
		

		

		

		

		

		  Amendment
		

		

		

		

		

		

		

		

		  Certificate/ Evaluation
		

		

		

		

		

		  Amendment
		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		X
		  Batch Notification
		

		

		

		

		

		  Others
		

		

		

		

		

		X
		  Batch Notification
		

		

		

		

		

		  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
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		Payment Details
		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		Amount:
		

		

		

		

		

		Amount:
		

		

		

	
	
		

		OR Number:
		

		

		

		

		

		OR Number:
		

		

		

	
	
		

		Date:
		

		

		

		

		

		Date:
		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		Date Effective:
		4-Nov-19
		Assessment Slip
		

		Date Effective:
		4-Nov-19
		Assessment Slip
		
	
		Form No.:
		QSP-CSL-PRO-01  Annex 3
		Revision No.: 02
		Page 1 of 1
		

		Form No.:
		QSP-CSL-PRO-01  Annex 3
		Revision No.: 02
		Page 1 of 1
		

 
 
 
 




Sheet 2: BN Form

	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
		

		

		

	
	
		

		A N T I B I O T I C   D R U G   P R O D U C T   B A T C H   N O T I F I C A T I O N
		

	
	
		

		

		

	
	
		

		

		B A T C H   N O T I F I C A T I O N   N U M B E R
		

	
	
		

		

		

	
	
		

		

	
	
		

		

		

	
	
		

		

		

	
	
		

		T O   B E   F I L L E D   U P   B Y   F D A   O F F I C I A L
		

	
	
		

		

		Date:
		

		

		

		

		Assessed and Received by
		

		

	
	
		

		

		

		Date
		

		

	
	
		

		P A Y M E N T   I N F O R M A T I O N
		

	
	
		

		THE DIRECTOR GENERAL
		

		Amount   Php
		

		

	
	
		

		Food and Drug Administration
		

		

	
	
		

		Civic Drive, Filinvest City, Alabang 1781
		

		OR Number
		

		

	
	
		

		Muntinlupa City, Philippines
		

		

	
	
		

		

		

		Date
		

		

	
	
		

		ATTENTION: COMMON SERVICES LABORATORY
		

		

	
	
		

		

		

		

		

		

		

		

		

		

	
	
		

		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
		

	
	
		

		

		

	
	
		

		

		P R O D U C T   P A R T I C U L A R S
		

	
	
		

		

		Generic Name/s
		:
		List of Generic Names (please use drop down menu)
		

	
	
		

		

		(to be filled up if the generic name is not found in the drop down menu)
		

	
	
		

		

		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
		:
		

		

	
	
		

		

		C O M P A N Y   P A R T I C U L A R
		

	
	
		

		

		Manufacturer's Name
		

		LTO Number
		

		

		

		LTO Validity
		

	
	
		

		

		

		

		

	
	
		

		

		Trader's Name
		

		LTO Number
		

		

		

		LTO Validity
		

	
	
		

		

		

		

		

	
	
		

		

		Importer's Name
		

		LTO Number
		

		

		

		LTO Validity
		

	
	
		

		

		

		

		

	
	
		

		

		Distributor's/Wholesaler'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
		

	
	
		

		

		

		

		

	
	
		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		NOTE:
		

		Please fill-out the form completely in A4 size paper and write all entries legibly.
		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		Date Effective:
		

		

		20 January 2020
		

		Batch Notification Application Form
		

	
	
		

		Form No.:
		

		

		

		

		

		

		QWP-A/ANT/W-01 Annex 1
		

		Revision No.: 11
		

		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;
		

	
	
		

		

		

		

		

		

		iv.
		

		Keep or hold FDA free and harmless against any and all third party claims arising from the above adverse 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 post-marketing 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.
		

	
	
		

		
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		Date Effective:
		

		

		20 January 2020
		

		Batch Notification Application Form
		

	
	
		

		Form No.:
		

		

		

		

		

		

		QWP-A/ANT/W-01 Annex 1
		

		Revision No.: 11
		

		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
		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

	
	
		

		Date Effective:
		

		

		20 January 2020
		

		Batch Notification Application Form
		

	
	
		

		Form No.:
		

		

		

		

		

		

		QWP-A/ANT/W-01 Annex 1
		

		Revision No.: 11
		

		Page 3 of 3
		

	



Sheet 3: DataBase

	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
		DATE
		BATCH NOTIFICATION NUMBER
		GENERIC NAME
		OTHERS
		BRAND NAME
		DOSAGE STRENGTH
		DOSAGE FORM
		ROUTE OF ADMINISTRATION
		BATCH NUMBER
		LOT NUMBER
		MANUFACTURING DATE
		EXPIRATION DATE
		REGISTRATION NUMBER
		CPR VALIDITY
		BATCH SIZE
		Theoretical Yield in Number of Units 
		Actual Yield/Volumne of Importation in Number of Units (as indicated in the commercial invoice) 
		Packaging Type
		Presentation or Pack Size
		Manufacturer's Name
		LTO Number
		LTO Validity
		Trader's Name
		LTO Number
		LTO Validity
		Importer's Name
		LTO Number
		LTO Validity
		Distributor's/ Wholesaler'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
		Company Name 
		Printed Name 
		Position/Designation
		Email Address
		Contact Number
		Date
		Assessed and Received by
		DATE
		OR NUMBER
		AMOUNT
		DATE
		VERSION
	
	
		30 December 1899
		

		List of Generic Names (please use drop down menu)
		(to be filled up if the generic name is not found in the drop down menu)
		0
		0
		0
		0
		

		

		0
		0
		

		30 December 1899
		0
		0
		0
		

		

		0
		

		30 December 1899
		0
		

		30 December 1899
		0
		

		30 December 1899
		0
		

		30 December 1899
		0
		

		30 December 1899
		0
		

		30 December 1899
		0
		0
		0
		0
		0
		30 December 1899
		

		30 December 1899
		0
		50.00
		30 December 1899
		Revision No.: 11
The words contained in this file might help you see if this file matches what you are looking for:

...Sheet as form republic of the philippinesdepartment healthfood and drug administrationcivic drive filinvest corporate cityalabang city muntinlupa assessment slip dtn lab no date december company name product information list generic names please use drop down menu expiry batchlot number samples type request certificate evaluation amendment x batch notification others lot release vaccine lgu purchases purchase analysis requested visual examination aerobic plate count dissolution coliformecoli mpn ph yeast molds identification test presumptive salmonella tablet hardness staphylococcus aureus sterility heavy metals baterial endotoxin lal vitamins assaypotency single component multi assessed by payment details amount or effective nov qspcslpro annex revision page bn a n t i b o c d r u g p h f m e l y received director general php food administration civic alabang philippines attention common services laboratory sirmadam in accordance with administrative order we wish to apply notify fda o...
Related files

Share

Help

Related files

Share

Share to social media

Help

Login Area
