Part 2 Good Manufacturing Practices for Pharmaceuticals
Chapter 2 Good Manufacturing Practices for Chinese Herbal Medicines
Section 6 Management of Raw Materials and Product Containers and Caps
Chinese herbal medicine factories shall establish detailed quality specifications for raw materials and product containers and caps, as well as operational procedures for the acceptance, labeling, storage, handling, sampling, testing and inspection of these items.
Containers that hold raw materials, product containers or caps shall be clearly labeled with batch numbers and status, pending-inspection, approved for use, not approved for use, or to be isolated; this information shall be entered into the disposition record of each batch.
Container caps shall, as needed, be fitted with children safety devices to prevent accidental consumption.
When Chinese herbal medicine factories receive shipments of raw materials, product containers or caps, they shall collect representative samples from each batch for testing; a note of this action shall be made on the original container.
Containers holding the samples described in the preceding Paragraph shall be appropriately labeled to facilitate tracking of sample names, batch numbers, sampling basis, original container and name of sampler.
The samples referred to in the preceding Article shall be tested in accordance with the following principles:
(1) Every raw material shall be tested to determine whether it is in compliance with documented specifications. However, aside from identification tests, other tests may be waived if the test reports provided by the supplier are evaluated and found to be reliable.
(2) Products containers and caps shall be tested to determine whether they are in compliance with established specifications.
(3) Where raw materials, product containers or caps are susceptible to contamination by filth, insects, foreign objects or microorganisms, thus affecting their intended uses, relevant test items and methods shall be included in the quality specifications for aforesaid items, and each batch shall be inspected for contamination.
Where raw materials, product containers or caps are tested and found to be in compliance with documented specifications, Chinese herbal medicine factories may approve them for use; where aforesaid items are not in compliance, they shall not be approved for use.
Raw materials, product containers or caps that are approved for use shall be used in the order of approval. However, where aforesaid items have been stored for long periods, exposed to the air or high temperatures, or subjected to other detrimental conditions, retesting shall be carried out.
Raw materials, product containers or caps that are not approved for use shall be labeled to this effect, and kept isolated prior to their proper disposal.