New Drug Approvals

Home » Regulatory » Is there something like Authorities’ approved production equipment?

Is there something like Authorities’ approved production equipment?

Advertisements
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Categories

Recent Posts

Blog Stats

  • 2,569,886 hits

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,381 other followers

add to any

Share
Advertisements

 

Is there something like Authorities’ approved production equipment?
Quite often the question comes up whether this or that piece of equipment is approved by authorities, or whether there are lists with approved equipment. Get the answer here.

http://www.gmp-compliance.org/enews_4364_Is%20there%20something%20like%20Authorities%27%20approved%20production%20equipment%3F_8398,8427,8428,9087,Z-PEM_n.html

 

GMP News
09/07/2014

Is there something like Authorities’ approved production equipment?

Quite often the question comes up whether this or that piece of equipment is approved by authorities, or whether there are lists with approved equipment. The question can be answered with a clear ‘No’. There are approvals for pharmaceutical products only, not for production equipment. Authorities or GMP guidelines neither allow equipment, nor do they forbid their usage (with the exception of filters emitting fibers). Here, companies have the freedom of choice but also the responsibility to use the equipment appropriate for their process or product. Standard equipment can be modified to fit best on the own process.

GMP guidelines require that the selected equipment is suitable for the application and which can be sufficiently cleaned and maintained. Surfaces that have contact with in-process material or product are supposed to be non-reactive, additive, or absorptive to prevent that the quality decreases beneath the defined requirement.

With regard to lubricants and synthetic/sealing materials this is different. The US FDA does not admit any seals, but has a white list of substances in their guidelines text they consider harmless. However, this merely means that these substances are not toxic in small quantities and therefore may be used. It does not imply their suitability for the own process or the proof of compatibility. For instance, EPDM is listed as sealant in 21 CFR 177.2600, but is not resistant in contact with oils or fats and may not be used in these cases.

With regard to lubricants there is also a Positive list in the CFR, to which the components of a lubricant must be traceable. Alternatively, lubricants can be listed by the NSF in the so-called White Book. To do this, the NSF offers a registration procedure, which shows the toxicological safety.

In addition there are organisations that may be of benefit for the selection of equipment or equipment parts. For example, the EHEDG checks and certifies the cleanability of equipment. The Fraunhofer IPA rates materials with respect to their cleanroom suitability. Here, cleanability, organic resistance, abrasion / particle emission and outgassing are examined.

 

Advertisements

1 Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

DR ANTHONY CRASTO

Follow New Drug Approvals on WordPress.com

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,381 other followers

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

Personal Links

View Full Profile →

bloglovin

Follow my blog with Bloglovin The title of your home page You could put your verification ID in a comment Or, in its own meta tag Or, as one of your keywords Your content is here. The verification ID will NOT be detected if you put it here.
%d bloggers like this: