WHO has recently issued draft
document titled "Guidelines on Validation". These guidelines (i.e., the main text included
in this working document) cover the general principles of validation and
qualification. These guidelines focus mainly on
the overall c...
FDA released a technical
reference document provides recommendations on the submission of data to
support quality metrics as part of the process validation lifecycle and
pharmaceutical quality system (PQS) assessment. The guide will provide clear
Computerized systems should be validated at the level appropriate for their intended use and in accordance with quality risk management principles. This applies to systems used in all good (anything) practices (GXP) activities (e.g. good clinical practice (...
US FDA has issued a draft
guidance, which provides recommendations regarding the control of elemental
impurities of human drug products marketed in the United States consistent with
implementation of International Council for Harmonization (ICH) guidance fo...
Original Article : CDER Conversations : US FDA Generic drugs are copies of innovator or brand-name prescription drugs and make up about 88 percent of prescriptions filled in the United States. Brand-name drugs must demonstrate their safety and effectivenes...
- Drug RegulationsFounder, 2010 - present
- Janssen PharmaceuticaSite Head & VP, 1990 - 2010
- University department of Chemical TechnologyPharmaceutical Technology, 1976 - 1984
“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
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New FDA Draft Guidance on Appropriate Size Range for Beads Administered ...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
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
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
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