Major equipment should be described in terms of capabilities, application, and location. Make and model would not normally be needed unless the equipment is new or unique. A diagram of major corporate organizational elements, with key manufacturing, quality control, and quality assurance positions highlighted, at both the manufacturing site and corporate headquarters, is also helpful.
A Type II DMF should, in general, be limited to a single drug intermediate, drug substance, drug product, or type of material used in their preparation. Summarize all significant steps in the manufacturing and controls of the drug intermediate or substance. Detailed guidance on what should be included in a Type II DMF for drug substances and intermediates may be found in the following guidelines:.
Each packaging material should be identified by the intended use, components, composition, and controls for its release.
The names of the suppliers or fabricators of the components used in preparing the packaging material and the acceptance specifications should also be given. Data supporting the acceptability of the packaging material for its intended use should also be submitted as outlined in the " Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics.
Toxicological data on these materials would be included under this type of DMF, if not otherwise available by cross reference to another document. Each additive should be identified and characterized by its method of manufacture, release specifications, and testing methods.
The DMF should include any other supporting information and data that are not available by cross reference to another document. FDA will then contact the holder to discuss the proposed submission. If a completed environmental assessment is needed, see 21 CFR Part Stability study design, data, interpretation, and other information should be submitted, when applicable, as outlined in the " Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics.
Each volume of a DMF should, in general, be no more than 2 inches thick. For multivolume submissions, number each volume. For example, for a 3 volume submission, the volumes would be numbered 1 of 3, 2 of 3, and 3 of 3. Paper length should not be less than 10 inches nor more than 12 inches. However, it may occasionally be necessary to use individual pages larger than standard paper size to present a floor plan, synthesis diagram, batch formula, or manufacturing instructions.
Those pages should be folded and mounted to allow the page to be opened for review without disassembling the jacket and refolded without damage when the volume is shelved. The agency's system for filing DMF's provides for assembly on the left side of the page. The left margin should be at least three fourths of an inch to assure that text is not obscured in the fastened area.
The right margin should be at least one half of an inch. See the page measurements shown in the following figure:. Beltsville, MD If the holder cross references 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. Quality Manuals What does the document contain? The Quality Manual is the overarching document of the QMS used to describe: the quality policy of the business entity the boundaries, operations and process improvement of the QMS throughout the product lifecycle management responsibilities the road map of the key processes of the QMS and their relationship to each other.
What Do the Different Regulations Require? How do you prepare site master file in pharma division. Leave a Reply cancel reply. No but preferred. No specific requirement. EU GMP. Yes mandated in Ch 4. ISO 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.
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