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WHO | World Health Organization
Technical specifications define the minimum requirements for the product to ensure good quality, safety and efficacy. The process to develop these specifications included: Analysis of the required to perform the clinical management of COVID-19 patients.
fda specification guidance

Guidance for Industry
FDA Regional Technical Specifications for ICH E2B (R3) Implementation ... ICSRs should not be submitted to the electronic Common Technical Document (eCTD) in a portable document file (PDF…
ectd pdf specifications

[DOC File]Product Design Specification Template
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Product Design Specification. Version VERSION HISTORY [Provide information on how the development and distribution of the Product Design Specification, up to the final point of approval, was controlled and tracked.
fda guidance on specification setting

[DOC File]1 THE QUALITY SYSTEM REGULATION
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FDA has determined that certain types of establishments are exempt from GMP requirements; and FDA has defined GMP responsibilities for others. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (820.198) or from general requirements concerning records (820.180).
fda pdf specifications guidance

[DOC File]USER REQUIREMENTS TEMPLATE
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Controls provided with a data collection systems intended for use in the manufacture of pharmaceutical products shall comply with 21 CFR, Part 11 of the FDA cGMP regulations. The Supplier shall stipulate the methods by which 21 CFR, Part 11 is met.
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[DOC File]Food and Drug Administration of the Philippines
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Release and shelf-life specifications of drug product. Batch numbering system (where applicable). Specification of drug substance. Holding time studies testing of bulk pack during storage and transportation between the bulk production site and primary packager (where applicable).
fda pdf guidance

[DOC File]Investigational New Drug (IND) Submission checklist
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Validation data and established specifications ordinarily need not be submitted at the initial stage of drug development. However, for some well-characterized, therapeutic biotechnology-derived products, preliminary specifications and additional validation data may be needed in certain circumstances to ensure safety in Phase 1. 10.
fda pdf spec

[DOC File]Fruit and Vegetable Labeling - USDA
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packages must include the name and address of the packer/dispatcher, the nature of the produce, its origin and commercial specifications. Commission Regulation 907/2004 amends the marketing standards applicable to fresh fruit and vegetables with regards to presentation and labeling.
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[DOC File]7
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Specifications for the hardware and software including directions for their use, if any, shall be included or referenced in the device master record [820.181]. The device master record [820.3(j)], as explained in Chapter 8, is a compilation of records containing procedures and specifications for a finished device.
fda specification guidance

DIVISION OF BIOEQUIVALENCE REVIEW
Place the MSWord format of all the tables in Module 2.7 and the pdf files in the appropriate eCTD/CTD locations. Margins for the paper should be 1” for the top and bottom and 1.25” for the ...
ectd pdf specifications

Fda pdf specifications