This document discusses Good Manufacturing Practices (GMP). It states that GMP ensures consistent and quality production of products according to standards. GMP was introduced in the Drug and Cosmetic Act of 1940 and rules of 1945 in India. The key components of GMP are personnel, facilities, equipment, material management, quality control, storage, complaints, product recall, and safety. Proper application of GMP provides leadership, builds a quality system, establishes policies and procedures, conducts reviews, analyzes data, performs audits, and promotes improvement.

1.  Name: Dr. Aijaz A. Sheikh
Associate Professor, Anuradha College of Pharmacy,
Chikhli, MS.
 Email: aijazpsd@gmail.com
 Course: Academic Writing
 Application Number:
567257d4e71a11e98838d948fd85664f

2.  GMP is a part of quality assurance which
ensures that products are consistently
produced and controlled to the quality
standards.
 GMP comes in schedule M in Drug and
Cosmetic Act 1940 & rules 1945 and
implemented in 1988.

3.  Personnel
 Surrounding and building facilities
 Equipment
 Materials management
 Quality control
 Storage
 Complaints
 Product recall
 Safety and environmental protection
COMPONENTS OF GMP

4.  Provide leadership
 Build the quality system to meet the
requirements.
 Establish policies, objectives and plan.
 Review the system.
 Analyse data for trends.
 Conduct internal audits.
 Risk assements.
 Promote improvement.
APPLICATIONS

5.  Pharmaceutical manufacturers, manufacture quality
medicines using various resources, in this human
resource is the most important.
 People must be qualified , experienced and trained.
 They must be sufficient in number.
 They must follow hygienic practices.
 They must have ability to perform the given task at
given level.
 They must have appropriate managerial skills.
PERSONNEL

6. PHARMA UNIFORMS

7.  Pharmaceutical premises should provide well
sanitation system.
 Electric supply, lighting, temperature, humidity and
ventilation should be appropriate and such that they
do not adversely affect directly or indirectly either the
pharmaceutical product during their manufacturing
and storage or the accurate functioning of the
equipment.
 Premises should be designed and equipped so as to
allot maximum protection against the entry of the
insects, birds, vermin and other animals particularly
rodents etc.
SURROUNDING, BUILDING & FACILITES

8. EQUIPMENTS

9.  The quality of the finished products solely depends
upon the quality inputs and hence materials
management becomes a very important activity.
 All raw material and other related materials should be
checked for following things after receiving.
 Name of the manufacturer or supplier.
 Name of the product.
 Quantity received and number of containers.
 Condition of container and materials.
MATERIAL MANAGEMENT

10. Quality control is a part of GMP concerned
with sampling specifications testing with the
organization, documentation and release
procedures which ensure that the necessary
and relevant test are actually carried out and
that materials are neither for use nor
products released for sale or supply , until
their quality has been taken consideration.
QUALITY CONTROL

11. Following points should be covered.
 External cleaning of container after receiving
and before storage.
 Quantity verification.
 Storage in specified area as per storage
conditions.
 Example: room temperature area.
 Low temperature area.
 Storage as per quarantine status of the
material.
STORAGE

12.  Employees who work in the organization
are one of the most important resource and
their safety during the employment and
particularly while they are working with
machines is of prime importance.
SAFETY AND ENVIRONMENTAL PROTECTION

13.  https://ispe.org/initiatives/regulatory-
resources/gmp
 http://www.csas.ed.ac.uk/__data/assets/pdf_
file/0011/38828/GMPinPharmaIndustry.pdf
 https://www.youtube.com/watch?v=07NLWo
PwDtg

14.  Academic Writing Course by UGC.

15.  Nirmal Kumar. Pharmaceutical good manufacturing practices
and good distribution practices - a comparative review of
diligence in regulatory standards. Indo American Journal of
Pharmaceutical Research, 2016,
 Shukla Anshika , Vishnoi Garima, Das Doli Rani. Current good
manufacturing guidelines for medicinal product. Journal of
Drug Delivery and Therapeutics, 2016; 6(2):57-61.
 Vikash Kumar Chaudhari, Vijay Yadav, Praveen Kumar Verma,
Amit Kumar Singh. A Review on Good Manufacturing Practice
(GMP) for Medicinal Products. PharmaTutor Magazine ,2(9),
8-19.