The initial ISO 14971 had 9 clauses, but later recently in Dec 2019 it is changed and now contains 10 clauses i.e 1 more clause is added. to view the new changed standard elements click below New and Changed Elements of ISO 14971:2019 Release – 3rd Edition Old ISO 14971 Clauses Clause -1 – Scope Read more about Overview of ISO 14971[…]
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[…]
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[…]
Subsystems interacting with The Design Control Process Management Controls Production and Process Controls Corrective and Preventive Action Document and Record Control Labeling and Packaging Control Risk Management Change Control QSIT Design control requirements Your Firm must have a 21 CFR 820.30 compliant design control process prior to submitting a 510(k), as well as during IDE Read more about FDA expectation from you during Design Control portions of Inspections[…]
Following are the key things you should look for pre approval inspection. Deviations, OOS, product failures Investigations and CAPA’s Label control QA oversight Management oversight Drug Safety and Pharmacovigilance projects Process, shipping cleaning method Vendor and contractor qualification and oversight Deviations gives the indication of break down in one or all of the following:Equipment, processes, SOP’s, Read more about Pre Approval Inspection and things to look for[…]
JPAL Laws, Ordinances and Notifications (relevant to GCP audits & the foreign manufacturer) The Pharmaceutical Affairs Law (Law No. 145 Established as of August 10, 1960; Law No. 87 Revised as of July 26, 2005)MHLW Ministerial Ordinance No. 36 Clinical Tests for Medical Devices (hereinafter referred to as “Medical Device GCP” or “JGCP”)YAKUSHOKUKIHATSU No. 0720005 Read more about Basics of Japanese Medical Device GCP (JGCP)[…]
Forms Commonly Used During FDA Inspections FDA 482 – Notice of of Inspection FDA 483 – List of Observations FDA 484 – Receipt for Samples FDA 463 – Affidavit Special purpose affidavits Various special purpose forms EIR – Establishment Inspection Report FDA 482 – called Notice of inspection FDA Investigators must formally identify themselves by Read more about what is FDA 482 and FDA 484 and other form used in FDA inspection[…]
Scope 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 requirements defined in Read more about FDA Guidance on Computerized Systems Used in Clinical Investigations[…]
NAI – No Action IndicatedSite is in compliance. No actions or response from site necessaryVAI – Voluntary Action IndicatedViolative practices noted that do not immediately jeopardize subject safety, but require correction action. Response necessary; follow-up inspection possibleOAI – Official Action IndicatedViolations severe enough to warrant immediate administrative actions. Reinspection likely Other InspectionsRoutine GMP auditsDirected audit Read more about FDA inspection & Top Reasons for FDA inspection[…]