How to create Risk Management Master Plan For FDA Regulated Companies

Posted on April 27, 2024April 27, 2024 by admin

The Risk Management Master Plan aims to ensure efficient and uniform execution of risk assessment and control procedures throughout the organization, aligning with regulatory standards, customer expectations, quality benchmarks, and business objectives. It also emphasizes the importance of comprehension and adherence to the company’s risk management protocols across all levels of the organization. This comprehensive Read more about How to create Risk Management Master Plan For FDA Regulated Companies[…]

Sponser Meeting with FDA some facts

Posted on August 18, 2020August 18, 2020 by admin

There are many meetings which a sponser can have with FDA related to the product being developed and to be approved by FDA. But it can be categorized in to 3 base categories. Type A: Critical Path (Urgent) meetings – Clinical hold, Safety Issues, Site disqualification, etc (within 30 days) Type B: Procedural meetings – Read more about Sponser Meeting with FDA some facts[…]

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)[…]

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 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)[…]

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[…]