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Do you have an established QMS? |
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YES.
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We are ISO certified. Standard: SI ISO 9001:2008
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and standard ISO 13485:2003
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Our manufacturing is governed by the Q7 guide
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Is your facility registered by FDA or USDA |
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NO |
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Do you have a Quality Manual? |
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YES |
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Do you certify your vendors, suppliers, sub-contractors? |
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YES. Our raw
materials suppliers suppliers must be ISO
certified. We perform an audit at our subcontractors manufacturing site,
and supervise their manufacturing operations |
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Do you supply Certificate of Analysis? |
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YES, CoA is included in all
shipments. |
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Do you supply Certificate of Origin? |
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Not routinely. Certificate of Origin is given to any customer who asks
for. Certificate of Origin is backed by the certificates of origin of
all animal-derived raw materials relevant to the product in question. |
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If you supply products that contain animal material, can you provide
information regarding the source, location, facility registration
numbers and animal health? |
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NO. In no case do we manufacture materials from animal source, though
we use animal derived raw materials in some manufacturing procedures. In
such cases, we only can present the documentation obtained from the
vendors. |
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Do you have a Change Control system? |
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YES. In the case of GMP/API products, all changes introduced into the
manufacturing procedure, raw materials, and analytical methods and
specifications, are registered in the Product
File, along with the reference to the
corresponding product development documentation. A new version of the
Master Product Record is then issued. |
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Do you provide change notifications to customers? |
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YES, only in cases of contract manufacturing of GMP/API products, and
only if that had been agreed upon |
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Do you have a quarantine system for nonconforming product |
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NO, we do not need quarantine, because in our system:
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Finished goods storage is physically separated from the
manufacturing.
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No product may be stored in the "finished goods storage" unless all
tests are successfully finished and it is finally approved and CoA
is issued.
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No product can be shipped without a final, approved CoA.
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Nonconforming product is either immediately disposed of, or
reworked, and does not leave the manufacturing area.
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Do you have "Out of Specs" investigation procedure? |
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YES |
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Do you have a CAPA (Corrective and preventive action) program? |
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YES |
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Do you have a procedure for conducting recalls? |
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NO. |
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Do you have a customer complaint handling system? |
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YES |
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Do you have a documented contigency plan established in the event
of an emergency or a natural disaster? |
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YES |
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Do you have an employee training program? |
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YES |
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Do you have approved manufacturing instructions? |
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YES |
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Do you have controlled records of manufacturing procedures? |
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YES |
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Do you review your manufacturing and resting records prior to product
release? |
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YES |
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Do you test test your products to established specifications? |
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YES |
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Do you have stability data |
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Yes, for products manufactured under GMP regime. |
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Do you have documented procedures for equipment / facility cleaning? |
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YES |
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Do you have an equipment calibration program |
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YES |
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