Bhopal

About Author:
Mr. Jagmohan Rai Agarwal,
M.Pharm (1968), Industrial experience SSI sector, nearly 37 years,
retired from own Industry (2004),
Founder President of M.P.Pharmacy Graduates’ Association (MPGA),
Ex President: M.P.Pharmaceutical Manufacturers’ Organisation (MPPMO),
Founder President : M.P. Small Scale Drug Manufacturers’ Association (MPSDMA),
Ex President Indian Pharmaceutical Association, M.P. State Branch, Indore (IPA),
Ex Vice Chairman Confederation of Indian Pharmaceutical Industries (SSI) (CIPI)
Recently submitted thesis for award of  Ph.D. on title “Enforcement of Drug Laws-Globalization vis-à-vis Indian Drug Laws”
(Email: sharda_jollo@yahoo.co.in)

A leading Pharmaceutical Company requires Medical Representative at all the major HQ's in India.

Post: Medical Representative & Area manager

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About Author:
Mr. Jagmohan Rai Agarwal,
M.Pharm (1968), Industrial experience SSI sector, nearly 37 years, retired from own Industry,
Founder President of M.P.Pharmacy Graduates’ Association,
President: M.P.Pharmaceutical Manufacturers’ Organisation,
Founder President : M.P. Small Scale Drug Manufacturers’ Association,
President Indian Pharmaceutical Association, M.P. State Branch, Indore,
Recently submitted thesis for award of  Ph.D. on title “Enforcement of Drug Laws-Globalization vis-à-vis Indian Drug Laws”
(Email: sharda_jollo@yahoo.co.in)

Quality of Pharmaceuticals has been a concern of the World Health Organisation (WHO) since its inception. The setting of global standards is requested in Article 2 of the WHO constitution which sites as one of the organisation’s functions that it should develop, establish and promote International standards with respect to food, biological, pharmaceuticals and similar products.

Campbell (US FDA) was the first leading architect of the present Federal Food, Drug and Cosmetics Act passed in 1938. He differed sharply with ‘Willey’ in his belief that Court proceedings were not the only proper way to secure compliance.

About Author:
Arif Khan,
Malhotra college of pharmacy
Bhopal, MP
RGPV Bhopal, India
 

Abstract
Document is any written statement or proof of any activity in pharmaceuticals. Documentations are to define the manufacturers system of information & control, to minimize the risk of misinterpretation & errors inherent in oral or casually written communication, to provide unambiguous procedures to be followed to provide confirmation of performance, to allow calculations to be checked & to allow tracing of batch history. Documents are a mirror to show actual image of any pharmaceutical company. Documents and products are produced in pharmaceuticals but regulatory bodies are interested to see documents first. Different documents can describe the different activity in pharma and its actual image. Various documents are producing by pharma company would be discussed below. Due to the importance given to documentation in pharma “good documentation practices” is required. Good documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any documents. Batch record is an important document kept along with reserve sample until one year of expiry of the product, and final products are release only after proper review of BMR, even after testing of Product from QC, product would not be released without review and completing of BMR and other documents .every activity should be available written form as SOPs is a requirements of GMP. Control of document is also an important part of GDP to reduce error and misuses of any documents. Master copy for all activity should be prepared such as SOPs started from Draft copy and finalizes after checking and reviewing and Approved by QA documentation. Final copy should be printed as Master copy and stamped as “master copy” by red ink. A photocopy of master copy should be issued to concern department with stamped “control copy”. A record should be maintained for issuing any documents with sign & date. Every document should have effective date, review date and revision no.

GPAT-2012 PAPER

{Answers are on the end page of question Paper}

Bhat Bio-tech India Private Limited is specialized in the design development, manufacture and marketing of diagnostic products and Biotechnology based products.

Post: Marketing Representative-(Life Sciences)

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The Indian Pharmaceutical Industry today is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously.