G M P - Documentation

G2 Business Excellence Consulting

India is growing rapidly as a

destination for medical device and
pharmaceutical manufacturing.
.
Costs to manufacture in India are
generally significantly less than the
costs in China. With more and
more Western medical companies
sourcing or manufacturing their
medical devices or drugs in India,
quality management including in
India has become a key issue

We have extensive experience with helping a number of international medical companies set up their
quality management systems in India. Our India quality control/quality assurance experts can help your
medical company’s Indian operations and suppliers ensure compliance with all relevant quality standards.

INDIA’S GOOD MANUFACTURING PRACTICE (GMP) STANDARDS

India’s GMP standards for medical devices and drugs are covered in Schedule M and Schedule M III of the
Drugs and Cosmetics Act (DCA):

Schedule M describes the quality assurance, self-inspection and/or quality audit, and quality control system
requirements for medical devices and pharmaceuticals; it also lists the requirements for the factory
premises, materials, plant, and equipment.

These requirements are based on World Health Organization guidelines.

For drugs, there are also additional specific requirements for small volume injectables, large volume
parenteral, APIs, tablets, capsules, etc.

India’s GMP regulations are now more aligned with ISO 13485. Standardizing quality requirements will help
manufacturers in India register their medical devices more effectively.

INDIA QUALITY CONTROL/QUALITY ASSURANCE FOR MEDICAL DEVICES

Depending on the type of medical device, the Drug Controller General of India (DCGI) and the State FDA will
approve or determine the medical device licensing process. The application for a manufacturing license
may include manufacturing processes, product details, and information about the staff. In addition, there
are many state and local level licenses that are needed to manufacture a medical device. Therefore,
understanding the regulations of a particular Indian State is important when deciding on a manufacturing
site location.

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© G2 BusinessExcellence (Consulting) 2019 - All Rights Reserved
 G M P - Documentation
G2 Business Excellence Consulting

INDIA QUALITY CONTROL/QUALITY ASSURANCE FOR PHARMACEUTICALS

Quality management systems in India should ensure compliance with India GMP, GLP (Good Laboratory
Practice), and GCP (Good Clinical Practice). The self-inspection and quality audit should be an evaluation of
GMP compliance with a team of in-house and/or external experts to audit the implementation and
document changes made. The quality control system should include sampling, specifications, testing,
documentation, release procedures, etc.

Under the Drugs and Cosmetics Act of 1940, all drug manufacturing requires a license. This license can only
be given to an entity based in India. The State Government Drug Controllers can oversee the manufacturing
of most drug products. Certain items, such as new drugs, large volume parenteral, vaccines, critical IVD kits
and r-DNA derived drugs require the approval of the Drug Controller General of India (DCGI) before the
license can be granted. The license is given for each factory and for the drugs made in that factory. In other
words, there are different licenses depending on the product group.

w: www.generationnext.in | t: +91 8076524311| e: g2businessexcellence@gmail.com

© G2 BusinessExcellence (Consulting) 2019 - All Rights Reserved