Sign Up

Sign up to our social GMP Questions and Answers Engine to ask and answer questions, and connect with other professionals.

Have an account? Sign In
or use


Have an account? Sign In Now

Sign In

Login to our social GMP Questions and Answers Engine to ask and answer questions and connect with other professionals.

Sign Up Here
or use

Forgot Password?

Don't have account, Sign Up Here

Forgot Password

Lost your password? Please enter your email address. You will receive a link and will create a new password via email.


Have an account? Sign In Now
You must login to ask question.

or use

Forgot Password?

Need An Account, Sign Up Here
Qualistery – GMP Knowledge Provider Logo Qualistery – GMP Knowledge Provider Logo
Sign InSign Up

Qualistery – GMP Knowledge Provider

Qualistery – GMP Knowledge Provider Navigation

  • Home
  • GMP Learning
    • Live GMP Webinars
    • Webinar Recordings
  • Resources
    • Articles
    • Podcast
  • Speaking & Sponsorship
    • Speaking Partners (Organization)
    • Event Sponsorship
    • Speaking and Training Opportunities For GxP Experts
  • Contact
  • My Account
Search
Ask A Question

Mobile menu

Close
Ask a Question
  • Home
  • GMP Learning
    • Live GMP Webinars
    • Webinar Recordings
  • Resources
    • Articles
    • Podcast
  • Speaking & Sponsorship
    • Speaking Partners (Organization)
    • Event Sponsorship
    • Speaking and Training Opportunities For GxP Experts
  • Contact
  • My Account
Home/ Questions/Q 816
Next
In Process
Adv
Qualistery
  • 0
QualisteryLevel 2
Asked: September 11, 20212021-09-11T07:39:32+02:00 2021-09-11T07:39:32+02:00In: Manufacturing

What are FDA’s primary concerns about pathogenic agent contamination of animal-derived drug ingredients?

  • 0
What are FDA’s primary concerns about pathogenic agent contamination of animal-derived drug ingredients?
  • 1 1 Answer
  • 72 Views
  • 0 Followers
  • 0
Answer
Share
  • Facebook
    Adv

    1 Answer

    • Voted
    • Oldest
    • Recent
    • Random
    1. Qualistery Level 2
      2021-09-12T11:36:31+02:00Added an answer on September 12, 2021 at 11:36 am

      Yes, FDA requires that animal-derived ingredients be controlled in a manner to ensure that contamination does not occur, beginning with initial collection and handling of the animal-derived material through its processing and subsequent use in a finished pharmaceutical. See, for example, the Federal Food, Drug, and Cosmetic Act (FD&C Act) section 501(a)(2)(A) and 501(a)(2)(B). FDA has special concerns regarding the vulnerability of animal-derived ingredients to contamination by pathogenic agents (i.e., agents that can cause disease or illness in humans or other animals). As background, ingredients are also called components, and there are two categories of components used in finished pharmaceutical production: inactive ingredient (often called excipients) and active ingredient (often called active pharmaceutical ingredient (API)).

      For the purpose of this guidance, an animal-derived ingredient is a substance of animal origin used to manufacture a drug product. They are primarily derived from byproducts of food production and include extractions from certain animal material and milked animal fluids (e.g., venoms) and may even be human-derived. Products of animal cell cultures, including monoclonal antibodies and therapeutic proteins, are not considered animal-derived APIs for the purpose of this guidance. For additional information concerning biotechnology products, refer to ICH guidance for industry Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

      Ingredient manufacturers are responsible for the quality and safety of the material they produce for use in finished pharmaceuticals. Ingredients are drugs and drugs are required to conform with current good manufacturing practice (FD&C Act, section 501(a)(2)(B)). Finished pharmaceutical manufacturers are also responsible for their selection, qualification, and use of ingredients in finished pharmaceuticals (e.g., the CGMP regulations at 21 CFR part 211, subpart E). Ingredient and finished pharmaceutical manufacturers should fully understand the potential for pathogenic agent contamination beginning with the livestock processing establishment (LPE) and continuing through subsequent handling and processing, and establish stringent controls to prevent contamination. It is also essential that appropriate tests or examinations are developed and applied to detect contamination as part of any meaningful control program.

      • 0
      • Reply
      • Share
        Share
        • Share on Facebook
        • Share on Twitter
        • Share on LinkedIn
        • Share on WhatsApp

    Leave an answer
    Cancel reply

    You must login to add an answer.

    or use

    Forgot Password?

    Need An Account, Sign Up Here
    Adv

    Sidebar

    Ask A Question

    Stats

    • Questions 103
    • Answers 117
    • Best Answer 1
    • Users 71
    • Popular
    • Answers
    • Anonymous

      tablet hardness

      • 5 Answers
    • Qualistery

      What is Data Governance?

      • 3 Answers
    • Qualistery

      What is data life cycle?

      • 2 Answers
    • Md.Mahamudul Hossain Robin
      Md.Mahamudul Hossain Robin added an answer It is Completely depends on the design . There is… December 7, 2022 at 4:53 am
    • Yan Kugel
      Yan Kugel added an answer Dear Nadia, a recall is an action which the manufacturer… October 8, 2021 at 5:20 pm
    • Marc García Gómez
      Marc García Gómez added an answer Pharmaceutical manufacturers must demonstrate that bacterial, fungal, and yeast contamination… October 3, 2021 at 12:31 pm

    Related Questions

    • Qualistery

      How many containers of each component from each shipment must ...

      • 2 Answers
    • Qualistery

      What are the Specs and Requirements for conducting visual inspection ...

      • 1 Answer
    • Qualistery

      Is analytical testing required at product changeover, on equipment in ...

      • 1 Answer

    Top Members

    Yan Kugel

    Yan Kugel

    • 0 Questions
    • 88 Points
    Level 2
    Qualistery

    Qualistery

    • 85 Questions
    • 78 Points
    Level 2
    Shashi Ravi Suman Rudrangi, RPh

    Shashi Ravi Suman Rudrangi, RPh

    • 0 Questions
    • 33 Points
    Level 1

    Trending Tags

    Active Pharmaceutical Ingredient Airlock ALCOA+ analytical api APIs archiving A true copy audit trail Authorized Person Batch Batch Records Batch Recovery batch reworking Bracketing Calibration capa CGMP Change Control Clean Area cleaning cold chain monitoring Confirmation Testing Consignment contact lens solution Contamination Control Strategy Corrective Action Cross Contamination Data Governance data life cycle Delivery Design Space document retention schedule Drug Master File effectiveness electronic signature finished Pharmaceutical Product flexible intravenous glass GMP gmp&iso 9001 Good Manufacturing Practices good practices (GxP) hbel HBELs healthbased exposure limit health based exposure limit in-process control (IPC) In Process Control InterCompany Transfer Intermediate Product lamellae Large Volume Parenterals manufacturers manufacturing Marketing Authorization medical device medicinal metadata Operational Qualification Packaging Packaging Material pathogenic Performance Qualification Pharmaceutical manufacturers Pharmaceutical Manufacturing Pharmaceutical Product Pharmaceutical Production Pharmacopeia pq PQR process validation Product products QA QC Qualification Quality Assurance Quality Control Quality Planning quality policy quality risk management (QRM) Quality Unit Quarantine question raw material Reconciliation Reprocessing Sampling Self Contained Area single product solution bags sop special Specification Standard Operating Procedure starting material supplier qualifications supplier quality suppliers technology transfer usp Validation validation batches Validation batches in a Technology transfer Validation Master Plan validation report vp vr

    Explore

    • Home
    • Add group
    • Groups page
    • Communities
    • Questions
      • New Questions
      • Trending Questions
      • Must read Questions
      • Hot Questions
    • Polls
    • Tags
    • Badges

    Footer

    Qualistery - GMP Knowledge Provider

    Qualistery is a GMP knowledge database, and a social Questions & Answers engine which will help you dominate the arena.

    Company

    • About Us
    • Contact Us

    Legal

    • Impressum – Legal Disclosure
    • Privacy Policy
    • Cookie Policy
    • Terms and Conditions
    • Disclaimer

    Services

    • GMP Online Education

    GMP Resources

    • Articles
    • Podcast

    Follow

    © 2022 Qualistery. All Rights Reserved

    Insert/edit link

    Enter the destination URL

    Or link to existing content

      No search term specified. Showing recent items. Search or use up and down arrow keys to select an item.