FDA CFR-21

Although usually considered to be inactive ingredients in ophthalmic formulations added because they impart viscosity, many of these polymers function as ocular lubricants. They are marketed as the active ingredients in OTC ocular lubricants used to provide relief from dry eye conditions. The regulatory requirements for these OTC products are found in the FDA CFR (21 CFR 349 Ophthalmic Drug Products for Over-the-Counter Human Use), and their formulations are presented in the 15th edition of the APhA Handbook of Nonprescription Drugs. 

The largest traditional use for montan waxes was as a component in one-time hot-melt carbon-paper inks. With the decrease in the use of carbon-paper inks, uses for the refined grades have become predominant, mainly in the formulation of poHshes and as plastics lubricants. The alcohol ester derivatives may be used as components of articles intended for use with foods as regulated by the FDA in 21 CFR 178.3770. 

Phosphate/polymer based multifunctional formulation, with low alkalinity to phosphate ratio for use in high alkalinity water containing some hardness. Program has USDA/FDA approval (CFR 21 173.310). 

FDA Indirect food additive for use only as a component of adhesives Yes FDA 1977a (21 CFR 175.105), 1977b... 

FDA (Food and Drug Administration). (1983). Good Laboratory Practices for Nonclinical Laboratory Studies, CFR 21 Part 58, March, 1983. 

The number on the outside of the case is required to be numeric or alphanumeric, not the name of the patient. Patient names are not permitted to be publicly disclosed in the context of a MedWatch report according to 21 CFR 21.63(f). The initial report is the first reported information received by the company about an individual s adverse drug experience. There must be a prompt attempt to obtain follow-up information about each initial report. The attempt(s) are made according to the company s written procedures. If the written safety procedures are not followed, the safety reports are not appropriately submitted, or the safety records are not appropriately kept, FDA has the authority under Section 80 of Part 315 to withdraw the market NDA. The follow-up report is the format for submitting additional information about an experience. Each case regards only one individual unless the experience is both temporally and clinically unrelated to a second event experienced by the same person taking the same drug product. 

Documentation comprises procedures, instructions, test methods,batch records, and so on that are documented and controlled. Documentation is prepared, reviewed, and approved by qualified personnel. Approved copies of documents are distributed to relevant departments and superseded copies are retrieved and archived. The retention period for each type of document is specified. Documents are issued with document and version numbers for ease of identification and reference. Master copies of documents are filed at secured locations with authorized access. Master copies stored in electronic media require validation in accordance with FDA regulation 21 CFR Part 11 (see Section 9.6.3) to assess the security of access and data integrity. Operators are trained and retrained to only apply the latest approved documents. 

In studies where subjects are mentally or physically unable to give proper consent, special arrangements will need to be made. Where appropriate, the ICF will be read to the subject in the presence of a witness, or consent will be provided by the next of kin or the subject s representatives. Studies in which the study subjects cannot provide informed consent will become more frequent as more difficult indications, for example, trauma, stroke, dementia and the handicapped or very young children, become the focus of clinical trials. The pharmaceutical physician should ensure that established mechanisms for consent are followed with agreement of the lEC and in compliance with ICH GCP chapter 4.8, FDA Title 21 CFR Part 50 sections 24-273 gpj p)ii-ective Articles 4 and 5. ... 

Both the ISO 9000 guidelines (ISO/IEC Guide 25 — see Section 2) and the GLP regulations (e.g., FDA regulations 21 CFR 58) stress the importance of the calibration of laboratory equipment. (See Box 5.3.) Indeed, properly calibrated test equipment is central to a laboratory s duty to successfully and accurately carry out its responsibilities. 

The U.S. Food and Drug Administration (FDA) regulation 21 CFR 211.194(a)(2) specifically states that users of analytical methods in the U.S. Pharmacopeia/National Formulary (USP/NF) are not required to validate the accuracy and reliability of these methods but merely verify their suitability under actual conditions of use. USP... 

The purpose of the following checklist is to help to determine if a computer system complies with the FDA Rule 21 CFR 21 Part 11 for electronic records and electronic signatures. This audit questionnaire apphes to systems that meet the definition of a closed system as defined in Section 11.3 (b)(4) of the rule and which do not utilize biometrics identification methods. 

When software is used for regulatory relevant analyses the FDA s 21 CFR Part 11 (http //www.fda.gov/ora/compliance ref/partll/) should be considered. 

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