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1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available at
http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
2. International Regulatory Affairs Updates, 2005. available at http://www.iraup.com/about.php
3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide for Prescription
Drugs, Medical Devices, and Biologics’ Second Edition.
4. Regulatory Affairs brought by learning plus, inc. available at http.//www.cgmp.com/ra.htm.
RECOMMENDED BOOKS (LATEST EDITIONS)
3. Industrial Pharmacy
Process which includes manufacturing, development, marketing and distribution of drug products
including quality assurance of the developed drug level.
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6. Dispensing unit
• It is associated with dispensing of raw material to production department.
It must
Dispense accurately
Store raw materials in specified conditions
Label properly
Dispense correct material
Maintain the dispensing area
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7. Production area
• The main area of the pharmaceutical facility which is responsible for manufacturing of
the pharmaceutical products
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8. Packaging and Labelling Unit
The quality of the packaging of pharmaceutical products plays a very important role in the quality of
such products. It must: —
• protect against all adverse external influences that can alter the properties of the product, e.g.
moisture, light, oxygen and temperature variations
• protect against biological contamination
• protect against physical damage
• carry the correct information and identification of the product
All finished drug products should be identified by labelling,
as required by the national legislation, bearing necessary information.
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10. Marketing department
Marketing department regulates and promotes sale of industry products by:
• Advertisements
• Banners
• Newspapers
• Brochures
• Social media
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11. Quality Control Management
Compromise on the quality of pharmaceutical products would mean a compromise on the overall
health of the patients and other clients. It is a well-known fact that good quality products are much
more efficient and effective. Production of an effective drug is the ultimate goal of any well-
meaning pharmaceutical company.
For a substance to be of quality, it should have 5 attributes:
• Identity
• Safety
• Purity
• Strength
• Effectiveness
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12. Engineering and accountant department
• Engineering department is associated with maintenance of building, resolving of mechanical and
electrical faults.
• Accountant department is associated in making budget of industry to check sale.
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13. Contents
• Pilot plant scale up techniques
• Technology development and transfer
• Regulatory affairs
• Regulatory requirements for drug approval
• Quality management systems
• Indian Regulatory Requirements
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14. Pilot Plant
Plant:- It is a place were the 5 M’s like money, material, man, method and machine
are brought together for the manufacturing of the products.
Pilot Plant:- It is the part of the pharmaceutical industry where a lab scale formula
is transformed into a viable product by development of liable and practical
procedure of manufacture.
Scale-up:- The art for designing of prototype using the data obtained from the pilot
plant model.
15. • Technology transfer is a logical procedure that controls the transfer of any process together with
its documentation and professional expertise between development and manufacture or
between manufacture sites.
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Technology development and transfer
16. Regulatory affairs
Regulatory Affairs is a comparatively new profession which has developed from the desire of
governments to protect public health, by controlling the safety and efficacy of products in areas
including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals,
cosmetics and complementary medicines
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17. Regulatory requirements for drug approval
• Different types of drug applications that can be sent to FDA
INDA
NDA
ANDA
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18. Quality management systems
TQM is a management approach for an organization, depending upon the participation of all its
members (including its employees) and aiming for a long-term success through customer
satisfaction.
Concept of quality
Quality by design
Biostatistics in Pharmaceutical Product development
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19. Indian Regulatory Requirements
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• Central Drug Standard Control Organization (CDSCO)
• State Licensing Authority
• Organization Responsibilities
• Certificate of Pharmaceutical Product (COPP)
• Regulatory requirements
• Approval procedures for New Drugs
