Site master file preparation: PIC/S explanatory notes for pharmaceutical manufacturers
SlideShare Explore Search You. Submit Search. Home Explore. Successfully reported this slideshow. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Upcoming SlideShare. Like this presentation? Why not share! Embed Size px. Start on. Fule related SlideShares at end. WordPress Shortcode. Like Liked. Anwar Munjewar. Validation Officer - Quality Assurance. Full Name Comment mastre here. Are you sure you want to Yes No. Niraj Zawar. Harshita Tripathi.
Chandrasekhar Chemarthi. Show More. No Downloads. Views Total views. Actions Shares. No notes for slide. Employees Details 4.
External Technical Assistance Organization Chart 2. Health Requirements for Personnel 5. Description of Manufacturing Area 2. Description how to make paper butterflies origami Water System 8.
Sanitation Cleaning 9. Brief Description of Production Maaster 2. Handling of Rejected Material 4. Process Validation Contract Audit 2. Review Certificate of Analysis Arrangements and Distribution System fi,e. Compliant Handling 3. Self Inspection System You just clipped your first slide!
Clipping is a handy way to collect important slides you want to go back to later. Now customize the name of a clipboard to store siite clips. Visibility Others can see my Clipboard. Cancel Save.
You are here
Jun 06, · A Site Master File (SMF) is a document prepared by a manufacturer that provides specific, factual information about the production and control of manufacturing operations at a named site, as well as any closely integrated operations nearby buildings. SMFs are internationally harmonised documents. The site master ? le (SMF) is prepared by the pharmaceutical manufacturer and should contain speci? c information about the quality management policies and activities of the site, the production and/or quality control of pharmaceut ical manufactur ing operat ions carr ied out at the named. The Florida Master Site File is administered by the Bureau of Historic Preservation, Division of Historical Resources, under the Florida Department of State. The Site File is a clearing house for information regarding Florida's archaeological sites, historical structures, and .
A premarket approval application PMA or an investigational device exemption application IDE usually contains data and other information that the applicant has developed and regards as trade secret or confidential commercial financial information. Often the applicant needs to use another party's product e. In order that a sound scientific evaluation may be made of the PMA, IDE, or other device submission, the review of data and other information related to the other party's product, facility, or manufacturing procedures is required.
The other party, while willing to allow FDA's confidential review of this information, may not want the IDE, premarket notification [ k ], or PMA applicant to have direct access to the information.
To help preserve the trade secrets of the ancillary medical device industry and at the same time facilitate the sound scientific evaluation of medical devices, FDA established the device master file system.
In addition, a master file may be considered when several applications may be submitted for different products which may use a common material or process, etc. Master files in support of other products regulated by FDA, even though they may contain information previously submitted in an MAF, are to be submitted to the appropriate FDA center s. The content and the way the master file is used may vary among FDA centers.
The following are commonly used terms relating to MAFs for devices and the documents referring to them:. Usually, MAFs are accepted from those organizations or persons who have not submitted or will not directly submit the information in a PMA, IDE, k , or other device-related submission to FDA for the reasons identified above.
MAFs may be submitted for various functions. These functions have been grouped by the following types:. There are no specific content requirements for a MAF. However, a submission will not be accepted as an MAF if it is not substantive in nature and does not contain information that may reasonably be regarded as trade secret or confidential commercial or financial information.
The submission must include a cover letter, preferably bearing company letterhead, signed by a responsible official e.
The letter should identify the submission as an MAF, and a contact person at the company or designated agent should be listed. An MAF must be in the English language or be accompanied by accurate English translations of any of the documents that are in a language other than English. After submission of an MAF, its information may need to be updated as a result of additional testing, additional applications of the MAF information or modification of the product that is the subject of the MAF.
Changes made in product or manufacturing operations can affect a client's medical device and possibly result in the client marketing a device differing from that originally approved by FDA. This can also have an effect on product liability obligations and a client's compliance with applicable FDA laws and regulations.
It is, therefore, necessary to notify a client before proposed changes are made in your operations or product. Their use of information in an MAF can only be authorized by the MAF holder or by a designated agent if so authorized. This authorization must be on company letterhead or that of the agent or representative. An MAF holder should provide a letter of authorization directly to a client with instructions that: 1 the original of the authorization letter be included in the original copy of the client's submission and 2 a copy be placed in each subsequent copy of the client's submission.
The latter, for trade secret or confidentiality purposes, may submit a description of its facilities, manufacturing procedures and processes, and quality control procedures in an MAF rather than provide this information directly to the client for inclusion in its submission. In their evaluation of the client's submission, FDA may inspect the MAF holder's facilities and manufacturing operations. A client's submission may be adversely affected if the MAF is incomplete or inaccurate.
This is especially true in the case of a PMA because of the statutory requirement that a PMA contain a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and when relevant, packing and installation of the device.
This will usually facilitate any clarification or correction of deficiencies in the MAF information. Identify any agent by name, address, and telephone number and specify any limitations in the authority of the agent or representative. If limitations are not specified, FDA will assume that all information in the MAF may be discussed with the agent or representative. A designated agent or representative can be added or removed only by amending the MAF. It is the submitter's responsibility to assure prepaid delivery to the above address.
Receipt will be acknowledged by letter of all new MAF submissions and amendments. Information in such summaries cannot be used to establish the safety or effectiveness for another device by any person other than the one who submitted the information.
FOI public disclosure provisions apply whether or not the information in the k , IDE, PMA, or other device-related submission was submitted by the applicant or is included by authorized reference to an MAF. MAF information already in the public domain is subject to disclosure e.
Introduction to Master Files for Devices MAFs A premarket approval application PMA or an investigational device exemption application IDE usually contains data and other information that the applicant has developed and regards as trade secret or confidential commercial financial information.
An "applicant" is an organization or person filing a PMA. A "sponsor" is an organization or person filing an IDE. These functions have been grouped by the following types: facilities and manufacturing procedures and controls; synthesis, formulation, purification and specifications for chemicals, materials e.
In the first volume of each copy, include a signed and dated cover letter identifying the submission as a device master file MAF and briefly describe the subject of the submission. Page sizes should not exceed 11 inches in length and 8 inches in width. Should it be necessary to use individual pages larger than the U. Individual volumes should not exceed 2 inches in thickness. Below is the format for a sample authorization letter.