Product Recall - GMP SOP

Rating:
100% of 100

Products on the market that are suspected or known to be seriously defective and/or pose a potential risk to patient health must be recalled. This must be done promptly, comprehensively and in accordance with any governmental health agency regulations and requirements governing distributed products.
This applies to all products manufactured and distributed from a site, including physician samples and commercial products used for market studies and clinical trials.

This 11-page SOP (Standard Operating Procedure)applies to all drug product and device manufacturers and describes the roles and responsibilities of the Recall Coordinator and the Recall Committee, as well as the order of events. It also includes 1 attachment - the recall decision flow chart.

Regular Price $140.00 Today $119.00
+ 19% german VAT when applicable


Payment methods

Description

Table of Content

1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Responsibilities and Accountabilities
4.1 Quality Head or Designee (Recall coordinator)
4.2 Recall Committee
5. Procedure
5.1 General
5.2 Preliminary Investigation and Information
5.3 Case Classifications
5.4 Factors to consider
5.4.1 Health Hazard
5.4.2 Depth of Recall
5.5 Recall Committee Meeting
5.6 Recall Documents
5.7 Public announcements
5.8 Recall Close out
5.9 Mock Recall
6. Definitions
7. Distribution
8. Attachment 1: Recall Decision Flow Chart

More Information

More Information
SKU Product Recall - GMP SOP

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.


7 days money back

Here's how it works: Download your copy of this document and if for any reason your aren't completely satisfied after SEVEN ENTIRE DAYS just give us a call, and we'll personally guarantee you get a complete refund.

Product Question

Click here to ask a new question
Newest
Most Helpful

Reviews 1

  1. Rating
    100%
    Very helpful document and easy to fill
    Product Recall - GMP SOP Review by on
Write Your Own Review
Product Recall - GMP SOP
Your Rating
Add Your Review
Do you want
15% OFF
Your first order?
Your coupon is below!
Coupon: df56s5d8