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- Title
GMP REQUIREMENTS FOR "BUILDINGS AND FACILITIES" FOR API - COMPARISON OF SCHEDULE M, INDIA AND ICH GUIDELINE AND APPROACH FOR COMPLIANCE TO DIFFERENT REGULATORY EXPECTATIONS.
- Authors
Patel, Kalpesh T.; Chotai, Narendra P.
- Abstract
India is one of the most attractive and promising pharmaceutical markets in the world. Majority of the Active Pharmaceutical Ingredients used in highly regulated countries are being outsourced from India and China. Globally, Indian pharma market ranks 4th in terms of generic production and 17th in terms of export value of bulk actives and dosage forms which indicates India is emerging as a universal powerhouse in the pharmaceutical business. Healthcare products marketed to a specific country should comply with Good Manufacturing Practices (GMP) regulations of that country, no matter where the products have been developed and manufactured. Unfortunately GMPs vary to some extent from country to country. On the other hand global pharmaceutical players are interested to market their products to different countries to leverage high development cost. Buildings and Facilities is a significant aspect of GMP requirements as expectations for efficient and effective manufacturing facilities is rising day by day. In light of above facts, attempt has been made to compare Indian GMP requirements w.r.t. internationally accepted ICH guideline and design approach for compliance to different regulatory expectations for "Buildings and Facilities".
- Subjects
INDIA; PHARMACEUTICAL industry; CONTRACTING out; GENERIC drug manufacturing; DRUG factories; MANUFACTURING processes
- Publication
Pharma Science Monitor, 2013, Vol 4, Issue 1, p3584
- ISSN
0976-9242
- Publication type
Article