The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in the Manufacture of Active Pharmaceutical Ingredients

New Drug Approvals

The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in the Manufacture of Active Pharmaceutical Ingredients

The occurrence of foreign particles in the manufacture of active pharmaceutical ingredients is always undesirable. For the responsible QA departments it involves an increased effort as concerns the search for the root causes and for CAPA measures. A new APIC Guidance offers concrete recommendations for the GMP compliant handling of foreign particles in APIs, intermediates and raw materials.

Foreign particles in APIs or medicinal preparations are undesirable and sometimes lead to a recall of the batches concerned. Depending on the type of particles their presence in active pharmaceutical ingredients may be harmless; in many cases they are inevitable. In any case the manufacturer must find an adequate way how to handle those impurities visible to the human eye. The search for a guideline or another official document in the relevant regulations…

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Finally published: new Annex 16 on QP Certification and Batch Release

New Drug Approvals

Finally published: new Annex 16 on QP Certification and Batch Release

The European Commission finally has published the new EU-GMP Guideline Annex 16 “Certification by a Qualified Person and Batch Release“.

The European Commission has published the final version of the revised EU-GMP Guideline Annex 16 “Certification by a Qualified Person and Batch Release”. Deadline for coming into operation is 15 April 2016.

As one important topic, it has been pointed out that the major task of a Qualified Person (QP) is the certification of a batch for its release. In this context, the QP must personally ensure the responsibilities listed in chapter 1.6 are fulfilled.  In chapter 1.7 a lot of additional responsibilities are listed which need to be secured by the QP. The work can be delegated and the QP can rely on the respective Quality Management Systems. However “the QP should have on-going assurance that…

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New Drug Approvals

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4′- . (2-Butyl-4-oxo- 1 ,3-diazaspiro [4.41 non-l-en-3-yl)methyll -N-C3.4- dimethyl-5-isoxazolyl)-2,-[(3.3-dimethyl-2-oxo-l- pyrrolidinvDmethyll [1.1 ‘-biphenyl] -2-sulfonamide



PRECLINICAL …..treating hypertension

Bristol Myers Squibb Co, INNOVATOR

Hypertension remains one of the largest unmet medical needs in the 21st century, especially when one considers that hypertension is the portent of future debilitating cardiovascular disease. While many drugs are available for treating the disease, approximately one-third of the hypertensive population is still not adequately treated. Of the more recent avenues explored for treating hypertension, disruption of the effects of either angiotensin II (AII) or endothelin-1 (ET-1) has shown promise. These endogenous vasoactive peptides are among the most potent vasoconstrictors and cell proliferative factors identified to date. AII is the effector molecule of the renin−angiotensin system (RAS), and a large number of AII receptor (AT1) antagonists, including irbesartan , have been…

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Invitation for National Seminar on CTD: Technical and Regulatory Requirement on 26th September, 2015

Dear All,

Greetings from Institute of Pharmacy, Nirma University.

It is the matter of great pleasure for us to invite you for National Seminar on “CTD: Technical & Regulatory Requirement” conducted by Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University and organized by Centre for Continuing Education, Nirma University on 26th September, 2015.

National Seminar is best suited for the regulatory Professional in the pharma regulatory field. The main objective of the program on CTD (Common Technical Document) filing is to provide the interface between the pharmaceutical industry and drug regulatory authorities across the world. As per global regulatory authorities, the products to be marketed must meet all the regulatory expectations with regards to quality, safety and efficacy. Its purpose is to ensure the dossier submission requirement in form of CTD which can eliminate the need to reformat the information for submission to the different ICH regulatory authorities.

 The important dates are as follows:

Last Date of Registration             : 19/09/2015

Confirmation of Registration       : 21/09/2015

By Email/Website

For further details, refer web site:

Who should attend?

Ph.D. scholars, M. Pharm. Students, Final Year B. Pharm. students, academicians and delegates from industry

For any query regarding registration contact Dr. Charmy Kothari (9898617612,, Co-ordinator.

Brochure is attached here for your information.

Dr. Charmy Kothari                                                   Dr. Priti Mehta

Co-ordinator                                                                Co-ordinator

Brochure – IPNU for National Seminar on CTD filling

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Dear studetns, Welcome to Pharma Regulatory FIeld

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