About Authors:
Salem – 636308, Tamil Nadu

Healthcare Regulatory Affair Professional with their experience and strong motivation to excel in the Regulatory field has an ability to motivate & give support and strengthen to teams members, involved in process ofproduct registration. Professional has taught a self-starter with the proven ability to prioritize and manage projects in a busy, fast-paced, multitasking environment, along with their experience in establishing relationship with the decision makers & coordinator. The Pharmaceutical industries are among the most highly regulated industries in the country. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. They are required to be well versed in the laws, regulations, guidelines and guidance of the regulatory agencies. There is a growing need to incorporate the current requirements of pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare the students with the latest developments to serve the industries. The present article discusses the regulatory education and its need, learning resources, courses available,syllabus contents and job opportunities in regulatory affairs.

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About Authors: 
Krunal Parikh1*, Mr. Maheshkumar Kataria2, Jatin Patel1
2Assistant professor, Department of pharmaceutics,
1Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA

Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized. It consequently strengthens the quality, and its consistency, of all goods and services, as those responsible for the specific operations have clear, unambiguous instructions to follow including active drug substances, is legally mandatory.

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Capecitabine Intermediate-cxpharma

New Drug Approvals





Jiangsu Chengxin Pharmaceutical Co., Ltd with total area 60,000m2 and total invested amount of RMB 300 million, is a high-tech joint-stock enterprise established in 2012, located in Binjiang Pharm-Chem Industry Park, Qidong, the outstanding cultural city well known as the Rivers and Seas Pearl in Jiangsu Province, close to Chongming Island with merely one separated river. It takes around 1 hour by car from the manufacturing site to Shanghai, the Yangtze River Delta economic metropoli……More

Dear sir,

We are just a manufacturer and very strong in the following intermediates:

Intermediates for Capecitabine:

2′,3′-Di-O-acetyl-5′-deoxy-5-fluorocytidine (CAS: 161599-46-8)

1,2,3-Triacetyl-5-deoxy-D-ribose (CAS: 62211-93-2)

Methyl-5-deoxy-2,3-O-isopropylidene-beta-D-ribofuranoside (CAS: 23202-81-5)

We have the dedicated workshop for Capecitabine intermediate. Our capacity is more than 20MT per month. Our company is complied with the requirement from EU GMP, US FDA and Chinese GMP. Just for your information.

If you are interested in any of above, please let me know.

Looking forward to your early reply.

Best regards,

Runya Wang(Ms) / Sales Department 

Add:     No.338 Shanghai Road, Binjiang Pharm-Chem

Industry Park, Qidong, Jiangsu, P.R.China 226221

Tel:       0086-513-86029596

Fax:      0086-513-86105399


Web:   in english

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Good Manufacturing Practices (GMP) are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices.

Most of the countries have their own regulation for GMP. I would like to discuss on how EMA (EU) GMP differ with the US FDA GMP.
After evaluation of the GMP regulatory comparison of both regulatory authorities, I found that compliance with EU GMPs will most likely also ensure compliance with FDA GMPs because EMA are much more specific and detailed in their guidances as compared to the US FDA
EMA GMP vs. US FDA GMP (A general comparison):
1. Cleaning Validation:
EMA: Annex 15,Clause 41-“Test until clean” is not considered an appropriate alternative to cleaning validation.
FDA: 2 Test until clean- For the system or equipment with a validated cleaning process, this practice of resampling should not be utilized and is acceptable only in rare cases (correspondence to EMA, clause 41, but used in rare cases)
2. Personal training:
a. EMA: Chapter 2, clause 2.9- Continuing training should also be given, and its practical effectiveness should be periodically assessed.
No FDA correspondence for periodic assessment
b. EMA: Chapter 2, clause 2.8- The manufacturer should provide training for all the personnel whose duties take them into production areas or into control laboratories (including the technical, maintenance and cleaning personnel
No FDA correspondence
3. Sample:
a. FDA uses the term reserve sample while EMA categorize sample into two types- retention and reference sample. EMA has additional guidance for retention sample.
b. There is no EMA correspondence to US FDA 21 CFR 211.176 (penicillin contamination)
4. Internal audits:
FDA does not specifically address the requirement to conduct, or to keep records of, internal quality assurance audits. EMA has a chapter on Self Inspection in their guidance documents (Chapter 9: Self Inspection)
5. Air room classification:
a. FDA classifies air on the basis of 0.5 micron only. EMA classifies air into 0.5 and 5 micron, respectively.
b. FDA provides air classification requirement for “in operation” only. EMA provides air classification for “dynamic” and “in operation”, respectively.
c. ISO 6 classification is defined only in FDA.
d. EMA provides the description of clothing required for each grade of cleanroom.
e. Blow/fill/seal technology- FDA: The classified environment surrounding BFS machinery should generally meet Class 100,000 (ISO 8), or better, standards, depending on the design of the BFS machinery and the surrounding room.
EMA: Blow/fill/seal equipment used for aseptic production which is fitted with an effective grade A air shower may be installed in at least a grade C environment, provided that grade A/B clothing is used.
f. EMA- For classification purposes in Grade A zones, a minimum sample volume of 1m cubic should be taken per sample location (No FDA correspondence)
6. Outdoor clothing:
EMA Annex 1, Clause 44- Outdoor clothing should not be brought into changing rooms leading to grade B and C rooms. (No FDA correspondence)
7. Labeling requirement for Investigational medicinal product (IMP):
EMA requires expiry date in the label of IMP {Annex 13, clause 26(j)}. FDA exempts the requirement of expiry date for IMP, except when the new drug is reconstituted at the time of dispensing. (21 CFR 211.137)
8. Packaging control for tamper-evident packaging:
FDA (21 CFR 211.132) provides regulation for tamper-evident packaging requirements for over-the-counter (OTC) human drug products. (No EMA correspondence).
A detailed information on GMP regulation can be found in EU legislation-Eudralex: Volume 4 of “The rules governing medicinal products in the European Union”containing guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human use and US FDA 21 CFR 210 and 21 CFR 211

Tips and Thoughts on Critical Process Cleaning Procedures

Latest FDA and cGMP Compliance News

How hard can cleaning be? That is something that people who are not involved in the production of pharmaceutical products may ask, but not people in the industry. The general thought process in the industry is that cleaning and cleaning validation is a practice that is necessary and unpleasant and best to be forgotten once it is done. But with the new process validation guidance that has come out from FDA in recent years, it is more important than ever to verify, control and improve our cleaning process validation procedures.!

EFPIA and PhRMA release their own guideline for sharing clinical trial data

 July 25 2013 | By Márcio Barra

Following news of the leaked memo from the European Federation of Pharmaceutical Industries and Associations (EFPIA) earlier this week that sparked a wave of controversy, the EFPIA and the U.S.’ Pharmaceutical Research and Manufacturers of America (PhRMA) released their joint set of principles detailing their strategy to allow a more open access to clinical trial data.

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Pharmacovigilance Risk Assessment Committee (PRAC) to review third and fourth generation oral contraceptives

January 29, 2013 | By Márcio Barra

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will review third and fourth generation combined oral contraceptives, under recent initiatives in France against these drugs. This comes as a request from France, and is  noteworthy as it is the first time, since the implementation of the new Pharmacovigilance Regulation adopted back in 2010, that a Member State has requested the European Agency to provide a recommendation or re-evaluation of a drug.

The PRAC will review the available data on the contraceptives and evaluate if the current information on them is of quality and accurate. Information on this review will be published following the next week meeting of the Committee, on 4 to 7 February 2013.

This review follows growing media reports about venous thromboembolism (VTE or blood clots) due to use of these contraceptives. A notorious case even went to court, after a woman, Marion…

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Breakthrough Therapy Designation for Firdapse to treat Lambert-Eaton Myasthenic Syndrome (LEMS)

TGI: Thrive Health

Recently, Catalyst Pharmaceutical Partners Received Breakthrough Therapy Designation From FDA for Firdapse(TM) for the Treatment of LEMS.

Company announced that its investigational product Firdapse(TM) (amifampridine phosphate) has received “Breakthrough Therapy Designation” by the U.S. Food and Drug Administration (FDA) for the symptomatic treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Firdapse(TM) is Catalyst’s investigational therapy that is being evaluated for the treatment of the debilitating symptoms associated with LEMS, including muscle weakness.

“We are very pleased to have received Breakthrough Therapy Designation for Firdapse(TM) and we are excited by the FDA’s decision to place our product in a category that may enable expedited development and review for patients with LEMS,” said Patrick McEnany, President and Chief Executive Officer of Catalyst. “With no approved or effective symptomatic treatment currently available for LEMS, Firdapse(TM) has the potential to be the first-line treatment option for patients with this rare condition.”

Breakthrough Therapy…

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Catalyst’s Firdapse Gets FDA ‘Breakthrough’ Designation

New Drug Approvals



used as phosphate salt

Catalyst Pharmaceutical Partners Receives Breakthrough Therapy Designation From FDA for Firdapse(TM) for the Treatment of LEMS

CORAL GABLES, Fla., Aug. 27, 2013 (GLOBE NEWSWIRE) — Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, today announced that its investigational product
Firdapse(TM) (amifampridine phosphate) has received “Breakthrough Therapy Designation” by the U.S. Food and Drug Administration (FDA) for the symptomatic treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Firdapse(TM) is Catalyst’s investigational therapy that is being evaluated for the treatment of the debilitating symptoms associated with LEMS, including muscle weakness.

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3,4-Diaminopyridine (or 3,4-DAP) is an organic compound with the formula C5H3N(NH2)2. It is formally derived from pyridine by substitution of the 3 and 4 positions with an 

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GLENMARK-A new way for a new world

New Drug Approvals


Traded asBSE532296NSEGLENMARK)
IndustryPharmaceuticalsDrugs &Healthcare
Founder(s)Gracias Saldanha
Key peopleGlenn Saldanha, MD & CEO [2]
ProductsMedicines and Vaccines
RevenueINR1031.10 crore(US$160 million) (2009–2010)[3]
Employees7,000 [4]
SubsidiariesGlenmark Generics Ltd[5]

Glenmark Pharmaceuticals is a pharmaceutical company headquartered in MumbaiIndia[6] It manufactures and markets generic formulation products and active pharmaceutical ingredients (API), both in the domestic and international markets. In the formulation business, its business spans segments such as DermatologyInternal MedicinePaediatricsGynaecologyENT andDiabetes.

It has four manufacturing facilities for formulations and additional three facilities for APIs. These manufacturing facilities are located in the states of MaharashtraGoaHimachal Pradesh and Gujarat in India.


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China’s arsenic contamination risk is assessed

Atasteofcreole's Blog

Nearly 20 million people in China could be exposed to water contaminated with arsenic, a study suggests.

Scientists used information about the geology of the country to predict the areas most likely to be affected by the poison.

The report is published in the journal Science.

Arsenic occurs naturally in the Earth’s crust, but if it leaches into groundwater, long-term exposure can cause serious health risks.

These include skin problems and cancers of the skin, lungs, bladder and kidney.

Geological maps

Until now, estimating the scale of arsenic contamination in large countries has been difficult.

China is thought to have more than 10 million drinking wells, and each needs to be screened to establish whether any toxic compounds are present. This process could take decades.

Instead, researchers from Switzerland and China looked at geological maps of the country.

“What it is very important to do is to go…

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