FDA Guidance on Computerized Systems Used in Clinical Investigations

Posted on August 2, 2020August 2, 2020 by admin

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[…]

Third party audit in food facility

Posted on August 2, 2020August 2, 2020 by admin

The difference between Regulatory and third party audit is at one side regulatory audits are concerned with compliance with code but thrird party audits go beyond codes and evalute the management of food safety systems. A facility can fail in third party audit though it is in compliance with regulatory requirements.Here are list of general Read more about Third party audit in food facility[…]

Basics of Japanese Medical Device GCP (JGCP)

Posted on July 30, 2020July 30, 2020 by admin

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)[…]

FDA inspection – Effective SOP for participants duty

Posted on July 30, 2020July 30, 2020 by admin

Following are key points need to be followed to have a successful FDA inspection. following people play major role in FDA inspections and hence the roles and responsibilities must be defined well and informed. -Receptionist Maintains a Current Inspection Contact List Actively in Contacting Key Personnel Trained on FDA Inspection SOP Does notReview – FDA Read more about FDA inspection – Effective SOP for participants duty[…]

FDA inspection & Top Reasons for FDA inspection

Posted on July 30, 2020July 30, 2020 by admin

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[…]

Dos and Don’t during and after FDA inspections

Posted on July 30, 2020July 30, 2020 by admin

This is a collection of facts from different experts and not the whole thing, there might be other dos and don’ts other than these applicable as per particular situation. Dos Present business card Be prepared Be organized Be calm Be professional Be confident Have Scribe present at all times during the interview Leave as soon Read more about Dos and Don’t during and after FDA inspections[…]

Pointers Inspectors look for during FDA inspection – For CAPA (QSIT)

Posted on July 30, 2020July 30, 2020 by admin

see that corrective action taken to correct existing product nonconformity or quality problems and Prevent recurrence of the problem The corrective action should Include explanations for how the firm will meet the requirements for all elements of the CAPA subsystem Gain working knowledge of the firm’s CAPA procedure before beginning evaluation of this subsystem Have Read more about Pointers Inspectors look for during FDA inspection – For CAPA (QSIT)[…]

FDA Validation compliance

Posted on July 30, 2020July 30, 2020 by admin

Q – difference between GMP & cGMP ? Ans -Essentially GMP and cGMP are one and the same with one significant distinction; the “c” denotes current. It is my understanding that the FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that Read more about FDA Validation compliance[…]

FDA Documentation Compliance

Posted on July 30, 2020July 30, 2020 by admin

Q – What would the FDA think about test documents with actual results typed in instead of being handwritten? Details – With global teams we have to do a lot of scanning of documents for pre and post execution review, some would like to type the results and signatures so they can be reviewed more easily Read more about FDA Documentation Compliance[…]

FDA Compliance General (Med device, Pharma, Biotech)

Posted on July 30, 2020July 30, 2020 by admin

Q – How can you define a varying load in sterilant? Answer -Usually the load selection is done by reviewing all the products in the sterile family and making a judgement. It may be helpful to get a bunch of product samples on a table in the conference room, and have a meeting with the Read more about FDA Compliance General (Med device, Pharma, Biotech)[…]