Y


Y 
 Y Y




 

 Y Y

 

Ō Define the term ´current Good
Manufacturing Practices (cGMP)µ.
Ō Explain the importance of current Good
Manufacturing Practices.
Ō Explain the application of current Good
Manufacturing Practices.


Y

Ō The methods employed in the manufacture
of biological medicinal products are a
critical factor in shaping the appropriate
regulatory control.

Ō Biological medicinal products can be

defined therefore largely by reference to
their method of manufacture.


Y

Ō The quality system used in companies that
make drug and related medical products is
called   
 ! ".
 Y 

 Y Y


Ō cGMPs have evolved within an ongoing
relationship between the government
(which seek to protect the consumer) and
the pharmaceutical industry.

Ō A quality system that has a sweeping effect

in every company that produces regulated
medical products.
 Y 

 Y Y


Ō The Good Manufacturing Practices are
quality principles formalized into regulations.

Ō Compliance with regulations is required by

law.

   
Ō Good manufacturing practice (GMP)
comprises that part of quality assurance
which is aimed at ensuring that a product is
consistently manufactured to a quality
appropriate to its intended use.

   
Ō GMP requires that:
(i) the manufacturing process is fully defined
before it is commenced; and

(ii) the necessary facilities are provided.


   
Ō In practice, this means that personnel must
be adequately trained, suitable premises
and equipment employed, correct materials
used, approved procedures adopted,
suitable storage and transport facilities
available and appropriate records made.

   
Ō Concerned with the manufacture of
medicines, and includes control of
ingredients, plant construction, process
validation, production, and cleaning.

Ō QC is that part of GPMP dealing with

specification, documentation and assessing
conformance to specification.

   
Ō With traditional QC, a high reliance was
placed on testing samples of finished
products to determine the overall quality of
a batch.

Ō This however, result in considerable financial

loss if non-compliance is detected only at
this late stage, leaving the expensive
options of discarding, or reworking (often
not possible), the batch.

   
Ō Additionally, a few microbiological test
methods have poor precision and/or
accuracy.

Ō Validation can be complex or impossible,

and interpretation of results can prove
difficult.

   
Ō End-product testing may also not prevent or
even detect the isolated rogue processing
failure.

Ō It is now generally accepted that a high

assurance of overall product quality can
only come from a detailed specification,
control and monitoring of all the stages
which contribute to the manufacturing
process.
 

 
Ō Compliance with the principles of GMP is
one of the major factors considered by the
Licensing Authority when examining an
application for a license to manufacture
under the Medicines Act (1968).

Ō Similar codes exist in the USA and other

countries.