Design Validaiton is a requirement of regulators prior to placing a product on the market. It is considered the last step of the Design Control process prior to transfer of the design to manufacturing. However, it is intimately tied to Process Validation a portion of Production Controls. Companies must assure that they are properly conducting Read more about What is design validation and what are rules applied[…]
This guideline is intended to help in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase I clinical trials. This guidance describes an approach to •Implementation of manufacturing controls that are appropriate Read more about CGMP guidance for Phase I Investigational Drugs[…]
Offlabel promotion is – the use of medical device for an indication not approved by FDA. Company Responsibilities Company has the responsibility for promotion, marketing and labelling of medical device. The FDA many monitor company’s practices and enforce regulations when necessary. enforcement may include criminal and civil actions Labelling All medical devices distributed by company Read more about Off Label promotion[…]
•“ Residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used in the manufacture of drug substances and impurities or excipients, or in the preparation of drug products •Residual solvents refers to the amount not removed during the purification of the product •Residual solvents are one of the three main types of Read more about Residual Solvent Analysis According to USP <467>[…]
There are three primary set of export and sanctions rules. These are: · U.S. Export Administration Regulations (EAR) · International Traffic in Arms Regulations (ITAR) · Economic Sanctions Regulations U.S. Export Administration Regulations Export Administration Regulations (EAR) are found in 15 CFR Parts 730 to 744. These are administered under International Economic Emergency Powers Act by the Commerce Read more about U.S. Export/Sanctions Laws[…]
HFE is a scientific discipline concerned with the understanding of interactions among human and other elements of a system it is Also called: •Usability engineering •Customer-centric design •User-centered design – A series of FDA standards and guidelines intended to ensure: -“Each manufacturer shall establish and maintain procedures to ensure that the design requirement related to Read more about Human Factors Engineering – Medical Device[…]
FDA’s definition of USE error though the word USE error is not used officially. “Act or omission of an act that results in a different outcome than intended by the manufacturer or expected by the USER, which may result from a mismatch situation between USER, man-machine interface, task and/or environment.” AAMI HE74:2001 Many research suggests Read more about USE error and medical device recall[…]
Scope of this guidance Computerized systems that contain data that support a marketing application –Case histories –Analytical test results (e.g., LIMS) –Data captured from analytical instruments –Electronic transcription of hardcopy source data it Does not apply to: –Computerized medical devices Study Protocols •Identify computerized system use within the trial process •Computerized systems must: –Satisfy process Read more about FDA Guidance on Computerized Systems Used in Clinical Investigations[…]
1 -Per Article 2, Audit is defined as “an investigation conducted by a sponsor or postmarketing sponsor, or one that a sponsor-investigator appoints a designated personto determine whether the clinical trial or postmarketing clinical trial is conducted according to this Ministerial Ordinance (No. 36) and the protocol or postmarketing protocolto ensure the reliability of the Read more about JGCP Audit Requirements[…]
An OOS result is generated when a drug product undergoing release testing or stability testing fails to meet an expected result or specification. When this happens, the FDA requires a valid reason must be determined to invalidate the OOS result and therefore an investigation into the cause of the OOS result must be conducted. OOS Read more about What is OOS and how to avoid it ?[…]