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CGMP Objectives and Policies.

The document outlines the objectives and policies of current Good Manufacturing Practices (cGMP), which ensure that pharmaceutical products are consistently produced to meet quality standards required for their intended use. cGMP emphasizes the importance of quality assurance throughout the manufacturing process, covering all aspects from production to delivery. Compliance with cGMP regulations is the responsibility of all personnel, with department managers accountable for adherence and the general manager holding final authority on GMP issues.

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Kunal Deshmukh
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2 views

CGMP Objectives and Policies.

The document outlines the objectives and policies of current Good Manufacturing Practices (cGMP), which ensure that pharmaceutical products are consistently produced to meet quality standards required for their intended use. cGMP emphasizes the importance of quality assurance throughout the manufacturing process, covering all aspects from production to delivery. Compliance with cGMP regulations is the responsibility of all personnel, with department managers accountable for adherence and the general manager holding final authority on GMP issues.

Uploaded by

Kunal Deshmukh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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cGMP : OBJECTIVES AND

POLICIES

Guided by- Presented by-


Anushree B Jambhalunkar
Dr. B. V. Bakde
Asso.Professor M.Pharm First Year
Department Of Pharmaceutics Department Of Pharmaceutics
What is GMP?
 Good Manufacturing Practice is
that part of Quality
Assurance which ensures that
the products are consistently
produced and controlled to the
quality standards appropriate
to their intended use and as
required by marketing
authorisation.
Current good
manufacturing practices
(cGMP)
 cGMP stands for current good
manufacturing practices. Here,
current stands for updating
technology in GMP.
 FDAregulates the quality of
pharmaceutical products very
carefully.
 Themain regulatory standard for
ensuring the quality of
 cGMP assures the identity, strength, quality,
and purity of drug products is built into the
design and manufacturing process at every
step.
 Consumer expect that each batch of medicines
they take will meet quality standards so that
will be safe and effective.
 cGMP provides for system that assure proper
design, monitoring and control of
manufacturing process, packing, holding of
cGMP According to
USFDA:-
 GMP ensures that quality is built into the organization
and processes involved in manufacture GMP covers all
aspects of manufacture.
 Includescollection, transportation, processing,
storage, quality control and delivery of the finished
product.
 Designed to minimize the risks involved in any
pharmaceutical production that cannot be eliminated
through testing the final product.
 Protect
the integrity and quality of manufactured
product intended for human use.
Objectives of cGMP
 cGmp’s seek to ensure that all the
manufacturer’s of regulated products effectively
implement a range of manufacturing controls
over the development and manufacture of
products, with objective of ensuring the
process outputs are of the highest quality
and consistently remain so over time.
 Theyare broad categories of requirements
which a manufacturer must adhere to,
however,the specific methods of implementation
may vary from one manufacturer to another.
Objectives of cGMP
 Ensure that products are consistently manufactured and
controlled to the specified quality.

 Concerned with all aspects of production and quality


control.

 In the manufacture of cosmetic products, overall control


and monitoring is required.

 Ensure that the consumer receives products of specified


quality.
Policies of cGMP
 The purpose of this policy is to ensure compliance
with current good manufacturing practice
regulations of FDA.
 Itis the responsibility of all the involved personnel
at every level of the organisation to act
immediately if a risk of violating this policy is
detected.
 Department Managers are accountable for
compliance with this policy.
 General Manager has final authority concerning
any GMP issue.

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