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Standardization
- A white paper has been developed to define
those tests and documentation where we believe
standardization will allow us to serve the
customer better and in a less confusing
manner
- A questionnaire was developed and
distributed to all interested members to
develop a industry wide view of current
testing. Data has been reviewed and a draft Standard Certificate of
Analysis was reviewed and approved
the annual meeting in
 April 2008.
- One objective of our organization is
to assist customers around the world in
relating quality and physiochemical analysis
of different batches or different regulatory
specifications.
- Members are now able to reference
our recommended minimum batch analysis (
C of A) with cross reference to internationally
recognized units of measure.
- Click here to review the entire text of the white paper on Definitions and QC Standardization
Traceability and Audit
Click here to review the ISIA traceability policy
Traceability
of serum origin throughout the supply chain
has become essential for all global GMP applications
for serum. We have identified the minimum
standard documentation that is required for
this purpose, and this is otlined in the document linked above. In future, you should expect to to see
the following documents from your supplier
when requested.
- A Certificate of Traceability from the
manufacturer of the goods certifying that
they have on file full traceability of the
origin and supply chain for the specified
batch of serum.
- A Certificate of Origin from the manufacturer
of the goods certifying the origin of the
original blood used for the production.
Certificate
of Traceability
- The manufacturer is required to maintain
records of traceability of all stages in
the supply chain for serum batches. This
includes auditable history of quality and
quantity of materials from Point of Collection
( Including specific animal numbers for
Donor Products), all stages of processing
and transportation or commercial transactions.
ISIA Audit
Program
- The ISIA is developing a standard audit
program that members will be able to attain
certification status. By completing this
rigorous independent industry review, members
can gain approval to affix the ISIA mark
on specific products and product literature. The Audit program can be reviewed in the members section.
- This certification will help customers
and regulatory agencies gain confidence
in the traceability and audit standards
for specific manufacturers and their products.
Quality Audit Agenda
- Those companies meeting the ISIA
audit requirements will be authorized
to use the ISIA Quality Mark as a symbol
of their commitment.
- In future you will be able to look for the ISIA quality
mark from your supplier .
- The documentation surrounding this program was approved at the 3rd Annual Meeting of ISIA in April 2008
Communication
- Initial interactions have been established
and are being actively nurtured with
- USDA - US Department of Agriculture
- DEFRA - UK Department of Enviroment Food and Rural Affairs
- SANCO - Directorate General for Health and Consumers (DG Sanco)
- AQIS - Australian Quarantine Inspection Service
- FDA - US Food and Drug Agency
- CFIA - Canadian Food Inspection Agency
- MAFF - New Zealand Mininstry of Food and Fisheries
- Face to face meetings have been held
with USDA, DEFRA and SANCO FDA and AQIS
- We are participating in the development
of the USP monograph
- The ISIA continues to interact with all
major regulatory agencies that relate to
pharmaceutical or agricultural products
that influence the importation or use of
serum products.
- The number of regulatory agencies continues
to increase with the ever expanding changes
in regulations.
- Our goal is to communicate with the global
regulatory agencies to make them aware of
our association and address common requirements
for our industry and stakeholders.
- Even with in the short history of the
Association, we have been able to talk
with a number of regulatory agencies and
have provided input to ensure workability
of proposed regulations.
- We are also meeting with a number of
other organizations and trade associations
to work together to harmonize common interests
and objectives. These Association Partners
include;
- EFPIA - European Federation
of Pharmaceutical Industries and Association
- EVM - European Vaccine Manufacturers
- EDMA - European Diagnostic
Manufacturers Association
- BPMA - British Pharmaceutical
Manufacturers Association
- IFAH - International Federation
for Animal Health
- AMLA
- Australian Meat and Livestock Association
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