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Uday Shetty
Works at Drug Regulations
Attended University department of Chemical Technology
Lives in Mumbai


Uday Shetty

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Uday Shetty

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WHO GMP's for Biological Products.
WHO issued a final guidance on
GMP for Biological Products.   This
document is intended to serve as a basis for establishing national guidelines
for GMP for biological products.   These
guidelines apply to the manufacture, control, and testing of biological...
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Uday Shetty

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Presentation on EU Annex 16 : Certification by QP
T he European Commission has published the final version of the revised EU-GMP Guideline Annex 16. This Annex deals with Certification by a Qualified Person and Batch Release. The Annex will be implemented on 15 April 2016. Major task of a Qualified Person ...
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Uday Shetty

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US FDA's GDUFA Learning Courses now available on the Web.
The FDA has launched two new web-based learning tutorials on the Generic Drug User Fee Amendments of 2012 (GDUFA) to provide an in-depth understanding of the GDUFA regulations and requirements.  " Overview of the Generic Drug User Fee Amendments of 2012 " o...
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Uday Shetty

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EDQM Renews its ISO 9001 Certificate
The EDQM  announced that after a comprehensive three-day certification audit, the French certification body AFNOR (AFAQ), decided in December 2015 to renew its ISO 9001 certificate granted to the EDQM. The EDQM is certified as meeting the requirements of IS...
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Uday Shetty

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EMA Work Plan and Plan for New Documents.
EMA has recently issued its 2016
Work Plan for the GMP/GDP Inspectors Working Group.   Highlights include the following: EMA will continue to make the
best use of EU inspection resources by leveraging information from
international regulatory authority part...
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Uday Shetty

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Presentations on US FDA / EU GMP's
Drug Regulations is a Not for Profit  Organisation  which provides free online resources for the Pharmaceutical Professional. Over the last three years we have published several presentations on various GMP topics. These have been very popular on the "slide...
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EU Bans Import from Astra Zeneca India
The competent authority of Sweden has issued a non-compliance
report following an inspection of Astra Zeneca’s plant in India in accordance
with Art. 111(7) of
Directive 2001/83/EC as amended. The report concludes that the company does not
comply with the G...
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Presentation on WHO Guidance :“Good Practices for Pharmaceutical Microbiological Laboratories”
The WHO Expert Committee on
Specifications for Pharmaceutical Preparations adopted in 2009 a revised
version of the Good practices for pharmaceutical quality control laboratories. During
the inspections carried out when prequalifying laboratories, the inspe...
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Uday's Collections
Quality Management
  • Drug Regulations
    Founder, 2010 - present
  • Pharmabiz
    Director, 2012 - present
  • Janssen Pharmaceutica
    Site Head & VP, 1990 - 2010
Map of the places this user has livedMap of the places this user has livedMap of the places this user has lived
Mumbai - Mumbai
Dr. Shetty is a  Pharmaceutical Management Professional with extensive experience in quality management, product development, technology transfers, commercial product support. His specialized expertise includes  contract manufacturing and process validations.  He has Supervisory experience in support functions like EHS, engineering and purchase.He is Quick and innovative thinker with ability to adapt rapidly to dynamic situations and is a consummate team player. 

In the immediate past he was the  Director at Contract Research Organization which he co-founded. Before that he was in leading Pharmaceutical companies like Janssen,GSK and Wyeth.He supervised large teams of Quality assurance, Quality Control and Product development. As a site head with Janssen he also supervised  general management functions like Finance, Purchase, Imports, engineering, EHS and Project Management. Dr. Shetty has set up, nurtured and grew number of organizations to deliver superior business results in the field of Quality management , Contract Research and Manufacturing. His specialties include Quality Management and Product Development. 
  • University department of Chemical Technology
    Pharmaceutical Technology, 1976 - 1984
Basic Information
Uday Shetty's +1's are the things they like, agree with, or want to recommend.
“No company will live or die because of high price premiums for drugs bu...

Reuters recently reported that Swiss drugmaker Roche plans to offer two blockbuster cancer drugs to the Indian consumers at significantly re

FDA issues a new SOP dealing with cargo thefts.

Warehouse thefts like Lilly's in 2010 are on the rise. Cargo theft mainly occurs during transportation as thieves make off with unattend

New PIC/S Recommendation for Risk-Based Inspection Planning in the GMP E...

This PIC/S Recommendation sets out a simple and flexible Quality Risk Management tool that may be used by Inspectorates when planning the fr

EMA's International Collaboration on Good Manufacturing Practice Inspect...

The European Medicines Agency has expanded the scope of the International Collaboration on Good Manufacturing Practice Inspection. The overa

FDA issues final rule for control & use of cut lables.

Due to significant problems with label mix ups and consequent recalls, FDA in 1987 and in 1990 reviewed the labeling procedures. The review

New FDA Draft Guidance on Appropriate Size Range for Beads Administered ...

Certain drug products that contain beads within a capsule indicate in the labeling that the capsule can be broken and the internal beads can

Should India Modify the Compulsory Licensing Provision of the Patent Law?

On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license

New FDA and EU regulations for packing of medicines.

Falsified medicines or counterfeits are a big problem in many parts of the world and has significant implications for patient safety. It als

New EU recommendations for laboratories that perform analysis of clinica...

Analysis and evaluation of samples collected from subjects participating in clinical trials forms a key part of the clinical trials process.

Is continuing manufacturing when acceptable smoke test results are await...

A scrutiny of the 483's and warning letters issued by the FDA in the last year or so indicate increasing vigilance of FDA on aseptic pro

Does WEST have monopoly over Moral and Ethical standards?

Chris Hansen of "Dateline" journeyed to India to expose CROs for indulging in unethical practices... Using publicly available info

New FDA guidance on Stability Evaluation

FDA has issued new draft guidance for Veterinary Medicine (CVM) which aims to implement the ICH requirements for Registration of Veterinary

Should Novartis withdraw the Patent Law challenge in India for Increment...

Ahead of the hearing of patent litigation for its anti-cancer drug Glivec in Supreme Court later this month, Novartis has said the outcome o

New FDA draft guidance on the use of Phthalates as Excipients.

Phthalate esters are synthetic chemicals with a broad spectrum of uses. Phthalates are found in certain pharmaceutical formulations, primari

Authorized Generics

Competition from authorized generics during the 180-day marketing exclusivity period has led to lower retail and wholesale drug prices. Spec

ICH S10 Guideline reaches Step 2 of the ICH Process

The purpose of this document is to recommend international standards for photosafety assessment, and to harmonise such assessments supportin

From Tylenol to Tylenol - A Missed Opportunity

Once upon a time many Johnsonian's and Ex-Johnsonian's were admirers of the J and J credo in light of the extraordinary positive les

Are Quality Professionals caught between the Devil and the Deep Sea ?

During last year Quality professionals have seen two large companies; Ranbaxy and Johnson and Johnson enter into a consent decree with the U