Form Fda 2512A – Fill Out and Use This PDF

Form FDA 2512A is a critical document in the Food and Drug Administration's workset. It outlines the requirements for Good Manufacturing Practice (GMP) Guidelines, including product registration instructions along with additional quality control and data accuracy regulations. This important form is every business’s go-to resource when it comes navigating through FDAs extensive set of guidelines which exist to promote public health safety. It serves as a way of streamlining the materials researching process while clarifying any questions relating to regulatory information from inception. Compliance with this form can provide premier results in terms of safety assuranceness, preventing bothersome situtions like rework or product recalls that may occur due to inconsistent practices between departments or other administrative errors otherwise unaccounted for. Completing FDA 2512A ensures that your businesses products are avaiable for sale without worrying about potential pitfalls associated with ambiguous recordkeeping or compliance discrepancies.

Form Fda 2512A PDF Details

Form FDA 2512A, also known as the Drug Master File (DMF), is a comprehensive and detailed compilation of information on drugs and biologics. The DMF exists to provide concise and accurate data about drug substances to regulatory agencies, manufacturers, and other interested parties. The DMF can be used to support various regulatory submissions, including new product applications, ANDAs, supplements, and variations. In order to create a high-quality DMF that meets all requirements, it is important to follow specific guidelines provided by the agency. This blog post will outline some key points to keep in mind when compiling your DMF submission. If you are interested in learning more about Form FDA 2512A or the Drug Master File process in general, please contact us today! We would be happy to help you get started on your submission.

Question	Answer
Form Name	Form Fda 2512A
Form Length	2 pages
Fillable?	No
Fillable fields	0
Avg. time to fill out	30 sec
Other names	UCM076746 dd form 2512

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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB N0. 0910-0027.	Expiration Date: August 31, 2017.
		See Burden Statement on Reverse of Part I.

FOOD AND DRUG ADMINISTRATION


COLLEGE PARK, MD 20740-3835	TYPE OF SUBMISSION:	ORIGINAL	AMENDED

COSMETIC PRODUCT INGREDIENT STATEMENT

FOR FDA USE ONLY ON ORIGINAL SUBMISSIONS

(In accordance with 21 CFR 720)

FDA CPIS NO.

FILING DATE

Read Instruction Booklet Before Completing. Type entries in CAPITAL LETTERS.

NOTE: This report is authorized by Public Law 21 U.S.C. 371(a); 21 CFR 720. While you are not required to respond, your cooperation is needed to make the results of this

voluntary program comprehensive, accurate, and timely.

INGRED NO.

1. COMMON, USUAL, OR CHEMICAL NAME

2. 9 - DIGIT CAS NO.

3. TYPE OF ACTION

4. DATE OF ACTION

5. CONF

6. BASE CPIS NO.

7. BASE NAME OR TRADE NAME MATERIAL

8. COMPANY NAME

1. COMMON, USUAL, OR CHEMICAL NAME

2. 9 - DIGIT CAS NO.

3. TYPE OF ACTION

4. DATE OF ACTION

5. CONF

6. BASE CPIS NO.

7. BASE NAME OR TRADE NAME MATERIAL

8. COMPANY NAME

1. COMMON, USUAL, OR CHEMICAL NAME

2. 9 - DIGIT CAS NO.

3. TYPE OF ACTION

4. DATE OF ACTION

5. CONF

6. BASE CPIS NO.

7. BASE NAME OR TRADE NAME MATERIAL

8. COMPANY NAME

1. COMMON, USUAL, OR CHEMICAL NAME

2. 9 - DIGIT CAS NO.

3. TYPE OF ACTION

4. DATE OF ACTION

5. CONF

6. BASE CPIS NO.

7. BASE NAME OR TRADE NAME MATERIAL

8. COMPANY NAME

1. COMMON, USUAL, OR CHEMICAL NAME

2. 9 - DIGIT CAS NO.

3. TYPE OF ACTION

4. DATE OF ACTION

5. CONF

6. BASE CPIS NO.

7. BASE NAME OR TRADE NAME MATERIAL

8. COMPANY NAME

1. COMMON, USUAL, OR CHEMICAL NAME

2. 9 - DIGIT CAS NO.

3. TYPE OF ACTION

4. DATE OF ACTION

5. CONF

6. BASE CPIS NO.

7. BASE NAME OR TRADE NAME MATERIAL

8. COMPANY NAME

1. COMMON, USUAL, OR CHEMICAL NAME

2. 9 - DIGIT CAS NO.

3. TYPE OF ACTION

4. DATE OF ACTION

5. CONF

6. BASE CPIS NO.

7. BASE NAME OR TRADE NAME MATERIAL

8. COMPANY NAME

1. COMMON, USUAL, OR CHEMICAL NAME

2. 9 - DIGIT CAS NO.

3. TYPE OF ACTION

4. DATE OF ACTION

5. CONF

6. BASE CPIS NO.

7. BASE NAME OR TRADE NAME MATERIAL

8. COMPANY NAME

1. COMMON, USUAL, OR CHEMICAL NAME

2. 9 - DIGIT CAS NO.

3. TYPE OF ACTION

4. DATE OF ACTION

5. CONF

6. BASE CPIS NO.

7. BASE NAME OR TRADE NAME MATERIAL

8. COMPANY NAME

1. COMMON, USUAL, OR CHEMICAL NAME

2. 9 - DIGIT CAS NO.

3. TYPE OF ACTION

4. DATE OF ACTION

5. CONF

6. BASE CPIS NO.

7. BASE NAME OR TRADE NAME MATERIAL

8. COMPANY NAME

FORM FDA 2512a (8/14) Previous Edition is Obsolete.

This Form Must be Securely Attached to Form FDA 2512.

PSC Publishing Services (301) 443-6740 EF

Page

Pages

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 20 minutes per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services	“An agency may not conduct or sponsor,
Food and Drug Administration	and a person is not required to respond to, a
Office of Chief Information Officer	collection of information unless it displays a
Paperwork Reduction Act (PRA) Staff	currently valid OMB number.”
PRAStaff@fda.hhs.gov

FORM FDA 2512a (8/14) (BACK)

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Form Fda 2512A writing process clarified (part 1)

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BASE CPIS NO F COMMON USUAL OR, CONF, and TYPE OF ACTION in Form Fda 2512A

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Previous Edition is Obsolete, TYPE OF ACTION, and COMPANY NAME of Form Fda 2512A

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Form Fda 2512A – Fill Out and Use This PDF

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