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...
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 ...
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...
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...
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...
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...
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...
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...
- Drug RegulationsFounder, 2010 - present
- PharmabizDirector, 2012 - 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