FDA expectation from you during Design Control portions of Inspections

Posted on July 31, 2020July 31, 2020 by admin

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[…]

What are the guidance documents that govern MDDs?(Microbial Data Deviation Investigations)

Posted on July 31, 2020July 31, 2020 by admin

Regulatory and Guidance Documents •2006 FDA Guidance for Industry – Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production. •ICH Q6A •ICH Q7A •USP 31 <1117> Best Microbiological Practice •Addressed in PMF Newsletter (Sutton and Settineri) http://www.microbiologyforum.org/PMFNews/PMFNews.12.11.0611.pdf (Sutton) http://www.microbiologyforum.org/PMFNews/PMFNews.13.06.0706.pdf (Settineri) •Addressed in PDA Draft Technical Report Points to Consider When Investigating Microbiological Data Deviations Read more about What are the guidance documents that govern MDDs?(Microbial Data Deviation Investigations)[…]

Pre Approval Inspection and things to look for

Posted on July 31, 2020July 31, 2020 by admin

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[…]

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[…]

what is FDA 482 and FDA 484 and other form used in FDA inspection

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

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[…]

FDA Guidance on Computerized Systems Used in Clinical Investigations

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

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[…]

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)[…]