Author: S Iyer
Price: Rs 990
Published by: D K Publications
3, Gopal Niwas, 1st floor
133, Princess Street,
Mumbai - 400002.
Although Indian pharmaceutical industry has grown to become an important segment of the Indian economy over the last 25 years, only about 500 pharma companies have adopted standard manufacturing practices in their production facilities. That would mean an estimated 18,000 medium and small scale units in the country are yet to upgrade their facilities and adopt procedures to comply with these requirements.
This upgradation of systems and procedures are now considered essential to bring in a uniform quality product eliminating the possibility of inter-batch and multi location variations. Now with the government determination to bring in a basic standard in manufacturing practices in pharmaceutical industry, compliance with the principles of GMP will become a statutory requirement for all pharma units with the introduction of the Revised Schedule M.
The European Community Guidelines on GMP includes annexes on qualification and validation, duties of a qualified person, parametric release of batches and manufacture of Active Pharmaceutical Ingredients. A number of other regulatory guidelines of organizations like International conference on Harmonisation, World Health Organisation are also available to pharma companies to help them implement cGMP. Adoption of improved quality management system and cGMP are critical for any company if it has to qualify for the export market also.
S Iyer's attempt, in this context, to compile these guidelines in a book format should be of great help for small pharma companies. This reference book has been divided into four parts starting with the section, basic requirements of GMP.
The second section deals with Application of GMP & quality guidelines for Pharmaceutical Products in 15 chapters. The section 3 reproduces the Revised Schedule M of the Drugs and Cosmetics Act, 1940 that comes into force from January 2004. And section 4 has three chapters dealing with WHO GMP principles for pharmaceutical products.