Standard Operation Procedures

Hosting Regulatory Inspections

NEW
Standard Operation Procedures
185,00 EUR
app. 244.20USD
(Non-german customers)

220,15 EUR
(German customers incl. 19% tax)



FDA
EMA
What you will get:
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.
GMP Money Back Guarantee
Here's how it works: Download your copy of this document and if for any reason your aren't completely satisfied after two entire months just give us a call, and we'll personally guarantee you get a complete refund.

Description of the Standard Operation Procedures - Hosting Regulatory Inspections

The aim of the Hosting Regulatory Inspections program is, firstly, to ensure that a well defined and professional inspection process during FDA or any other regulatory Inspection in connection with pharmaceutical development, manufacturing, testing of materials products or medical devices at your site.

This is a must and also crucial prerequisite for a successful outcome of the authority inspection. This Standard Operating Procedure (SOP) provides all information that should be considered during a regulatory inspection. The SOP covers the whole inspection, starting with the arrival of the investigators/inspectors on site, following the inspection activities and ends with the final close out meeting of the inspection.

The SOP gives also an overview about the organization of the inspection team and the roles and responsibilities of the involved site personnel like Inspection Coordinator, Scribe, Runner and Subject Matter Expert. This 18-page SOP, which includes four attachments – is ready to use and only needs small site specific adoption.

Table of Content

1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Responsibilities and Accountabilities
4.1. Responsibility of Receptionist or designee
4.2. Responsibility of all Employees
4.3. Responsibility of Quality Assurance Manager or designee
4.4. Responsibility of Quality Assurance Personnel or designee
4.5. Responsibility of Regulatory Affairs Department
5. Procedure
5.1. General Considerations
5.2. Arrival of the Inspector/Investigator
5.3. Inspection Opening Meeting
5.4. During the Inspection
5.4.1 General
5.4.2 Daily Debriefing Meetings
5.4.3 Daily Internal Meetings
5.4.4 Inspection Closing Meeting
5.4.5 Post-Inspection Meeting
5.5. Observations Requiring Corrective Actions
5.6. Preparation of Formal Responses
5.7. Compiling the Inspection File
6. Definitions
7. Distribution
8. Attachments
Attachment 1: Inspection Roles
Attachment 2: Regulatory Inspection Summary
Attachment 3: Opening and Closing Meeting Attendance
Attachment 4: Submission of Samples to Regulatory Agencies

Hosting Regulatory Inspections
185,00 EUR
Additional 19% tax for customers from Germany
Customers who bought this item also bought:
Change control system
85,00 EUR
20.2% also purchased this product.
Annual product review
90,00 EUR
14.66% also purchased this product.
Corrective and preventive action (CAPA)
100,00 EUR
13.68% also purchased this product.
NDA field alert
100,00 EUR
9.12% also purchased this product.
Handling of OOS results
100,00 EUR
7.82% also purchased this product.
Returned drug products
85,00 EUR
7.49% also purchased this product.
Stability Study Program / Plan
200,00 EUR
7.17% also purchased this product.
Validation Master Plan Drug Product Manufacturing
200,00 EUR
5.21% also purchased this product.
PAI protocol for drug products
210,00 EUR
3.91% also purchased this product.
Classification evaluation approval of cleaning agents
75,00 EUR
2.28% also purchased this product.
Contract manufacturer solids - contractor quality questionnaire
210,00 EUR
1.95% also purchased this product.
Product Recall
120,00 EUR

eCommerce Engine © 2006 xt:Commerce Shopsoftware