Are you worried about an inspection from the FDA, MHRA, or another global regulatory agency? Use the anxiety and learn about inspection and audit best practices in our series of blogs on inspection management.

The Importance of First Impressions on Inspection Day

Did you know that the first impression significantly impacts the audit inspector? The Inspector uses first impressions to gauge the confidence and “state of control” of your company. Find out how to make a good impression by reading this blog. Also, learn about what to do when the Inspector visits unannounced.

 

Greeting
Teamwork for inspections and audits

Building an Inspection Team

Inspections of a pharmaceutical or medical device manufacturing company may have more than one Inspector. There is usually a team of company employees managing the requests of each Inspector. Who should be on your inspection team?

This blog outlines who should be on the team and what the team should be doing before inspection day.

Inspection Day: Who to Call 

Although the Quality Assurance Department leads the inspection day, Subject Matter Experts (SMEs) will be asked questions by the FDA inspectors. How to choose which SME to use? Read this blog to find out.

Practice Audits

The internal inspection team should be running audits to practice for surprise inspector visits. Practicing audits provides your Quality Assurance Department with information on gaps in readiness. Plus, practicing audits improves your confidence and gives the inspector assurance that you are in a state of control. Read about internal audits and how to improve your company one department at a time in this blog.

Inspection Management Software

The Inspector will request a multitude of documents. How can you keep track of the requests? On inspection day, you need to monitor who is filling the request, whether Quality Assurance has approved the document, whether the Inspector has received the record, etc. Using a combination of chat, email, excel sheets, etc., is time-consuming. The longer you take to fulfill a request, the more chaotic and not in a state of control you seem. Using an all-in-one inspection management software such as AuditUtopia® or ACE® Inspection can speed up your request fulfillment. Learn more about inspection management software in this blog.

Inspection Management Software PSC
Inspection

Fulfilling Requests on The Inspection Day

This blog covers paper requests, electronic requests, and interview requests. This series of articles was written in collaboration with a former FDA inspector. Don’t miss our top tips! Find out the best practices for fulfilling requests.

Wrapping Up the Inspection

 How you handle the end of an inspection? An audit might last several days. You may have some bad news. Read our blog on how to meet challenges and address concerns.

 

PSC Biotech® and PSC Software® provide support for inspections and audits.

PSC Biotech® experts have extensive knowledge and experience with submitting Global Regulatory Documents. We provide all highly regulated industries with pre-market and post-market activities for global life science submissions. Our teams develop and implement regulatory strategy, provide guidance on regulations and standards, review and maintain project documentation and records, participate in risk-benefit analysis for regulatory compliance, generate and manage submission files, and review and author submission documents.

PSC Software® options for inspection management include AuditUtopia® and ACE® Inspection. Read our case studies on how AuditUtopia streamlined inspection management for global pharmaceutical companies.

C&Q in Process Validation

How Thermo Fisher Scientific Streamlined Inspection Management With AuditUtopia®

With the cost of a failed regulatory inspection approaching hundreds of thousands of dollars, the VVS division needed a dedicated solution to manage their regulatory and client inspections. Thermo Fisher’s VVS division soon found that one software, AuditUtopia®, stood above the rest.

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Auditing – Quality Systems and Records

The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control”. PSC Biotech® appointed a Project Manager and a Senior Supplier Quality Auditor who successfully developed and maintained a supplier audit schedule in consultation with the client quality team.

Past Projects

 Validation (IQ, OQ, and PQ) of the HVAC system Reconnection

 Validation (IQ, OQ, and PQ) of the HVAC system Reconnection

Validation (IQ, OQ, and PQ) of the HVAC system Reconnection    Requalification of the HVAC system  Area: Zhubei, Hsinchu County, Taiwan Project Type: Qualification About this Project OBJECTIVE Qualification protocol and summary generation, and qualification...

cGMP Program Compliance and Gap Analysis

cGMP Program Compliance and Gap Analysis

A cGMP Program Compliance and Gap AnalysisPerform cGMP compliance and Gap analysis Area: Saskatchewan – Saskatoon, Regina Project Type: Auditing About this Project OBJECTIVE Assess that client's quality systems are in compliance with current Good Manufacturing...

Temperature Controlled Chamber Qualification

Temperature Controlled Chamber Qualification

Temperature Controlled Chamber Qualification  PSC consultants performed qualification protocol and summary generation, and qualification execution.   Area: Orange County, CA Project Type: CQV and Metrology About this ProjectOBJECTIVE To qualify multiple refrigerated...

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