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)[…]

California Hazardous Waste Regulations

Posted on July 19, 2020 by admin

California has unique hazardous waste regulations that include, but substantially exceed requirements of the federal Resource Conservation and Recovery Act (RCRA) regulations generally in effect in other states. It is also hard to navigate California’s hazardous waste requirements because of the dramatic differences in substantive requirements, enforced by pervasive local city and county agencies deputized Read more about California Hazardous Waste Regulations[…]

Guidance on pulse oximeter applications

Posted on July 19, 2020July 19, 2020 by admin

March 4 2013, The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices. In the guidance, the FDA specified new rules for identifying, testing and assuring safety for the systems. The new document overrides the Read more about Guidance on pulse oximeter applications[…]

Records FDA inspectors look for – related to Quality system

Posted on July 15, 2020July 15, 2020 by admin

The FDA’s QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. QSR allocated the information into four documents. The Design History File (DHF) gives a history of device design. One of the design outputs is the Device Master Record (DMR). The Device Master Record (DMR) Read more about Records FDA inspectors look for – related to Quality system[…]

FDA warning Indian drug manufacturing units – Is it a retaliation to court ruling against Novartis

Posted on January 27, 2020 by admin

One after other drug manufacturing units of India getting warning letters or getting banned to manufacture licenses getting cancelled. Is this a systematic fight back (to the set back of patent disputes in favor of local generic manufacturers) by big pharma by their arm twisting techniques or is it real the plants are not following procedures. Today Hospira’s manufacturing unit in Read more about FDA warning Indian drug manufacturing units – Is it a retaliation to court ruling against Novartis[…]

Schedule of Penalties by OSHA

Posted on January 27, 2020January 27, 2020 by admin

Typically when an employer has violated any rules or standards related to OSHA , OSHA sends a citation and proposed penalty by registered email and it is must for the employer to put the copy of citation at the place of violation for at least 3 days or until the violation is rectified. Below are Read more about Schedule of Penalties by OSHA[…]