Custom Search

Saturday, September 12, 2009

Penicillin Drugs requirements manufacturing Penicillin Drugs

1. What is Penicillin?

Penicillin is a group of antibiotic which is defined as a group of natural or semi-synthetic

antibiotics derived from fungi strains of the genus Penicillium.


Generally, all penicillin share a three-carbon, one-nitrogen, and

four-member cyclic amide structure, known as the beta-lactam ring.






2. What are the Penicillin drugs?


The Manual of Clinical Microbiology, 9th edition, identifies penicillin drugs as follows:

Natural Penicillins:

Benzylpenicillin* (commonly known as penicillin G)

Benzylpenicilloyl-polylysine (BPP)

Phenoxymethyl penicillin* (commonly known as penicillin V)

Semi-synthetic Penicillins:

Methicillin

Nafcillin

Cloxacillin*


Dicloxacillin*

Ampicillin*

Amoxicillin*

Bacampicillin

Pivampicillin

Carbenicillin

Ticarcillin*

Azlocillin

Mezlocillin

Piperacillin

Hetacillin*

*Penicillins approved for veterinary use

Please be aware that penicillin trade names may vary by region and country. Manufacturers, including repackers, are responsible for knowing whether their drug is penicillin. US FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) or Drugs at  FDA, both of which are located at US FDA’s website, enable searching by trade name (i.e., proprietary name) and by active ingredient name (i.e., generic or non-proprietary name).


3. Why cross-contamination is a serious concern with penicillin drugs?

Penicillin can become a sensitizing agent in a contaminated product which triggers a hypersensitive exaggerated allergic immune response in some people. Differences in the chemically substituted 6-aminopenicillanic acid side chain can generate allergic reactions ranging from skin rashes to life-threatening anaphylaxis.


4. Are there special manufacturing requirements for Penicillin drugs?


Yes, all penicillin finished pharmaceutical manufacturers, including repackers, are required by the CGMP regulations to establish a comprehensive control strategy designed to prevent cross-contamination of other drugs with penicillin. These requirements include:



21 CFR 211.42(d): Separation of facility and equipment



21 CFR 211.46(d): Separate air handling systems (HVAC)



21 CFR 211.176: Test for traces of penicillin where possible exposure exits.



Penicillin Active Pharmaceutical Ingredients (APIs) are also required to be manufactured under CGMPs in accordance with Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. US FDA has published internationally harmonized guidance on the manufacture of APIs; see

International Conference on Harmonization (ICH) Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Chapter 4, section 4.4 of this guidance describes actions API manufacturers,
including those who manufacture or package APIs or penicillin intermediates, are to follow to ensure such material is contained and does not contaminate other drugs.
-------------------------------------------------------------------------------------------------------
We have written many articles on cgmp , sterile pharmaceutical manufacturing , we have provided all pharmaceutical SOPS , and all sample documents over this website.


We encourage you to subscribe to this website by entering your email ID , we send our articles by email to you as and when this website is updatedRegulatory affairs in pharmaceutical industry.

Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing

What is a High-Efficiency Particulate Air Filter (HEPA Filter

FDA guidelines

SOP for  pharmaceutical manufacturing company

What is CFR 21 part 11

Pharmaceutical Validation

Cleen Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

Media fill

Regulatory Affairs in Pharmaceutical Industry

No comments:

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org