Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distribution Record)

Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distribution Record)

1. DEPARTMENT OF PHARMACEUTICS TOPIC: DOCUMENTATION IN PHARMACEUTICAL INDUSTRY(MASTER FORMULA RECORD,DMF,DISTRIBUTION RECORD) PRESENTED BY: RUSHIKESH SHINDE (M.Pharm,First Year) GUIDED BY: DR.NALANDA BORKAR MADAM (Head Of Department Of Pharmaceutics) Survey No. 50,Marunje,Near Rajiv Gandhi, IT Park, Hinjawadi,Pune,Maharashtra,411028 ALARD COLLEGE OF PHARMACY [1]

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3. MASTER FORMULA RECORD Definition: A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls. 3

4. MASTER FORMULA RECORD Master Formula Record (MFR) is a master document for any pharmaceutical product . MFR contains all information about the manufacturing process for the product. MFR is prepared by the research and development team of the company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units. MFR is also called Master Manufacturing Record, Master Production Record 4

5. There shall be Master Formula records relating to all manufacturing procedures for each product and batch size to be manufactured. These shall be prepared and endorsed by the competent technical staff i.e. head of production and quality control. MFR plays an important in consistency for each batch manufacturing 5

6. MFR should contain 6 Product Details : Name, logo and address of the manufacturing company. Dosage form name. Brand name. Generic name. Product code Label claim of all ingredients Product description Batch size Pack size and packing style

7. Shelf life Storage conditions MFR number and date Supersede MFR number and date Effective batch number Authorization by the production and quality assurance head F low Chart: Steps of the manufacturing process to be monitored. Flowchart of the material movement from dispensing to the final product to stores. Equipment: Create a list of all required equipment and machines required in the manufacturing process with their capacity . 7

8. Special instructions : Write down the precautions special instructions to follow during product manufacturing and packing and these should also be added in the batch manufacturing formula. Calculations: Include the calculation steps of all active materials to get the 100% of the active material. The calculation shall be done using water or LOD to get 100% potency . 8

9. Manufacturing Process: Write all steps in all stages of the manufacturing process. All process steps like shifting, milling, lubricating, granulation, compression and coating should be written in detail including the process time and yield. It also include atmospheric conditions as temperature, humidity, and storage conditions for every step. Packing Process: List of all packing materials with their quantity is written. Line clearance, reconciliation of printed and unprinted packing materials should be included in details. Yield: Include the theoretical, actual yield and acceptance limit of the batch. 9

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11. Contents 11 Introduction Types of DMF Submission of DMF – 1.Transmittal lette r 2. Administrativ e Information Authorization to refer DMF Holder Obligation Closure of DMF file DMF(DRUG MASTER FILE)

12. I n t r o d u c t i o n 12 A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation and a DMF is submitted solely at the discretion of the holder (a person who owns a DMF). The info r m a t i on co n t a ined in the DMF m a y be used t o sup p ort an I n ves ti g ati o na l New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these. But a DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application.

13. Drug Master Files are provided for in 21 CFR 314.420. This guideline is intended to provide DMF holders with procedures acceptable to the agency for preparing and submitting a DMF. The guideline discusses types of DMF's, the information needed in each type, the format of submissions to a DMF, the administrative procedures governing review of DMF's, and the obligations of the DMF holder. DMF's are generally created to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file. When an applicant references its own material, the applicant should reference the information contained in its own IND, NDA, or ANDA directly rather than establishing a new DMF. 13

14. Types of Drug master file 14 TYPES ESSENTIAL CONTENTS I Manufacturing site, facilities, operating procedure and personnel II Drug substance & intermediate, material used and drug product III Packaging material IV Excipient , flavor , essence, colorant, & material used in preparation V FDA accepted reference information

15. Submissions Of Drug Master Files 15 Each DMF submission should contain a transmittal letter, administrative information about the submission, and the specific information to be included in the DMF as described in this section. The DMF must be in the English language. Whenever a submission contains information in another language, an accurate certified English translation must also be included. Each page of each copy of the DMF should be dated and consecutively numbered. An updated table of contents should be included with each submission.

16. Transmittal Letters 16 Identification of submission: Original, the type of DMF as classified in Section III, its subject. Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers. Signature of the holder or the authorized representative. Typewritten name and title of the signer . Administrative Information Names and addresses of the following: DMF holder. Corporate headquarters. Manufacturing/processing facility. Contact for FDA correspondence. Agent(s), if any. The specific responsibilities of each person listed in any of the categories. Statement of commitment- A signed statement by the holder certifying that the DMF is current and that the DMF holder will comply with the statements made in it.

17. Authorization To Refer A Drug Master File 17 Letter of Authorization to FDA Before FDA can review DMF information in support of an application, the DMF holder must submit in duplicate to the DMF a letter of authorization permitting FDA to refer the DMF. If the holder cross refers its own DMF, the holder should supply in a letter of authorization the information designated by items 3, 5, 6, 7, and 8 of this section. The holder does not need to send a transmittal letter with its letter of authorization.

18. The letter of authorization should include the following: The date. Name of DMF holder. DMF number. Name ofpersons authorized to incorporate information in the DMF by reference. Specific products covered by the DMF. Submission dates Section numbers and/or page numbers to be referenced. Statement of commitment that the DMF is current and that the DMF holder will comply with the statements made in it. Signature of authorizing official. Typed name and title of official authorizing reference to the DMF. 18

19. Holder Oligation 19 The reference should include the date, volume, section, and/or page number affected. Any change or condition including a change in authorization related to specific customers should be submitted in duplicate and adequately cross referenced to previous submission

20. Closure Of A Drug Master File 20 A holder who wishes to close a DMF should submit a request to the Drug Master File Staff stating the reason for the closure. The request should include a statement that the holder's obligations. The Agency may close a DMF that does not contain an annual update of persons authorized to incorporate information in the DMF by reference and a list of changes made since the previous annual report. The holder will be notified of FDA's intent to close the DMF.

21. Distribution Procedures- 21 Distribution Record

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26. Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quality shipped, and lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers. The primary purpose is to ensure that adequate data are available to access trade customers should a recall be initiated. The recording of lot number to each order will certainly accomplish this purpose. 26

27. The recordings of dates on which a specific lot of product commenced and ceased distribution may be used. All customers receiving the product between these dates could then be contacted. Obviously on the first and last days of distribution, some of the customers may have received product from the end of previous lot or the beginning of the next lot. This overlap should in no way adversely impact on the effectiveness of a recall. Whatever system is used, it must accommodate the reintroduction of returned goods into the distribution chain. 27

28. Distribution records include a wide range of documentation such as invoices, bills of lading, customers’ receipts, internal warehouse storage and inventory records. The information required need not be on every document. Also customer codes and product codes may be used as alternates to customer names and address and product names. 28

29. References Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and IsaderKaufer,Marcel Dekker series, Vol.1432.Assesed Date:23 rd Feb,2021 The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P.Martin, Drugs and the Pharmaceutical Sciences,Vol.185, Informa Health care Publishers.Assesed Date:24 th Feb,2021 Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons.Inc . Vol.1432.Assesed Date:23 rd Feb,2021 FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics/edited By Douglas J. Pisano, David Mantus . Publishers.Assesed Date:24 th Feb,2021 https:// www.slideshare.net/Documentation In Pharmaceutical Industry.Assesed Date:24 th Feb,2021 www.fda.gov/Documentation.Assesed Date:24 th Feb,2021. 29

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