We provide WHO GMP Certification Service to
our clients. GMP (Good Manufacturing Practices) is
a standard defined by WHO (World Health Organization).
GMP WHO certification ensures that products are consistently
produced and controlled to the quality standards appropriate
to their intended use and as required by the marketing
authorization.
W.H.O. defines Good Manufacturing Practices (GMP) as "that
part of quality assurance which ensures that products
are consistently produced and controlled to the quality
standards appropriate to their intended use and as
required by the marketing authorization". GMP
covers all aspects of the manufacturing process: defined
manufacturing process; validated critical manufacturing
steps; suitable premises, storage, transport; qualified
and trained production and quality control personnel;
adequate laboratory facilities; approved written procedures
and instructions; records to show all steps of defined
procedures taken; full traceability of a product through
batch processing records and distribution records;
and systems for recall and investigation of complaints.
The guiding principle of GMP is that quality is built into a product, and not
just tested into a finished product. Therefore, the assurance is that the product
not only meets the final specifications, but that it has been made by the same
procedures under the same conditions each and every time it is made. There are
many ways this is controlled - controlling the quality of the facility and its
systems, controlling the quality of the starting materials, controlling the quality
of production at all stages, controlling the quality of the testing of the product,
controlling the identity of materials by adequate labeling and segregation, controlling
the quality of materials and product by adequate storage, etc. All of these controls
must follow prescribed, formal, approved procedures, written as protocols, SOPs,
or Master Formulae, describing all the tasks carried out in an entire manufacturing
and control process.
GMP covers all aspects of the manufacturing process including:
- Defined manufacturing process
- Validated critical manufacturing steps
- Suitable premises, storage, transport, qualified
and trained production and quality control personnel
- Adequate laboratory facilities
- Approved written procedures and instructions
- Records to show all steps of defined procedures
have been taken
- Full traceability of a product through batch records
and distribution records
- Systems for recall and investigation of complaints