• GMP Trends
  • Home
  • About
  • Publications
  • Pricing
  • FAQs
  • Store
  • News
  • Contact
  • My Account

GMP News

  1. Home
  2. GMP News
pest control for pharmaceutical
Posted on October 14, 2022October 12, 2022
Have you established a pest control program?

Buildings used in the manufacture, processing, packing, or holding of drug products must be maintained […]

Read More >>
  • by Dina Kisver
  • 0
proper storage conditions
Posted on September 30, 2022September 29, 2022
Are you following proper storage conditions for your APIs?

Proper storage conditions for active pharmaceutical ingredients (APIs) is important to ensure the identity, strength, […]

Read More >>
  • by Dina Kisver
  • 0
Establishing written cleaning procedure
Posted on September 15, 2022September 13, 2022
Are you following your written cleaning procedure?

According to the Code of Federal Regulations (21 CFR 211.67 Equipment Cleaning and Maintenance), an […]

Read More >>
  • by Dina Kisver
  • 0
computer system validation
Posted on September 1, 2022August 30, 2022
Have you validated your lab computer systems?

The security of your laboratory’s data plays a major role in the safety of your […]

Read More >>
  • by Dina Kisver
  • 0
rework procedure for medical devices
Posted on August 15, 2022August 12, 2022
Have you established a rework procedure for your medical device?

A rework procedure consists of the corrective actions when a product has failed to meet […]

Read More >>
  • by Dina Kisver
  • 0
CAPA effectiveness
Posted on August 1, 2022September 8, 2022
Are you performing your CAPA effectiveness check?

According to the Code of Federal Regulations (21 CFR 820.100 Corrective and Preventative Action), each […]

Read More >>
  • by Dina Kisver
  • 0
acceptance activities in medical devices
Posted on July 15, 2022September 8, 2022
Have you established acceptance activities for your medical devices?

According to the Code of Federal Regulations (21 CFR 820.80 Acceptance Activities), each manufacturer shall […]

Read More >>
  • by Dina Kisver
  • 0
root cause evaluation - oos investigation
Posted on July 1, 2022September 8, 2022
Do your OOS Investigations include root cause evaluation and follow-up?

According to the Code of Federal Regulations (21 CFR 211.192 Production Record Review), the failure […]

Read More >>
  • by Dina Kisver
  • 0
oos investigation
Posted on June 17, 2022August 19, 2022
Are You Prepared for an Out of Specification (OOS) Investigation?

Download the Out of Specification (OOS) Investigation Checklist for free using promo code babymilk1 The […]

Read More >>
  • by Jacob Fishkow
  • 0
supplier evaluation program
Posted on June 15, 2022July 7, 2022
Do you have a supplier evaluation program?

According to the Preamble to the Good Manufacturing Practices (GMPs), the intent of a supplier […]

Read More >>
  • by Dina Kisver
  • 0

Posts navigation

Older posts
Newer posts
Stay in Compliance!

To get the most out of GMP Trends®, sign up to one of our subscription packages for valuable, up-to-date information you won't find anywhere else!

LEARN MORE
About GMP Trends

GMP TRENDS is a publication for the pharmaceutical and medical device industries, trending observations made by FDA investigators during GMP inspections throughout the world.

#

GMP Trends® was founded because, as quality professionals, we recognized the need for an unbiased editing of all relevant FDA 483's.

Contact Us
Address
PO Box 1111 Firestone, CO 80520
Mail
gmp@gmptrends.com
Phone
303-443-8716
Recent Posts
  • Do you have sufficient stability data to support your expiration date?
    March 15, 2023
  • Are you performing an effective line clearance before packaging product?
    March 1, 2023
Stay In Compliance

Get the latest news and highlights from GMP Trends

Copyright GMP Trends All Rights Reserved

Search GMP Trends

Did you know: Our entire report archive has been indexed! This means, our members can search across thousands of 483 observations and pinpoint the exact info they need!