BS ISO 19617:2018 pdf free

BS ISO 19617:2018 pdf free.Traditional Chinese medicine – General requirements for the manufacturing process of natural products
As a general principle, premises shall be designed, located, constructed, adapted and maintained to suit the operations according to GMP, as the premises could be potentially affected by degradation and infestation of certain pests and are sensitive to microbiological contamination, production, and particularly storage of crude drugs and crude drug preparations.
a) Storage areas shall be well organized and tidy. Special attention shall be paid to cleanliness and good maintenance. Any accidental spillage shall be cleaned up immediately using methods that minimize the risk of cross-contamination of other materials, and shall be reported.
b) The areas shall be well labelled and crude drugs stored in such a way as to avoid any risk of cross-contamination. An area shall be identified for the quarantine of all incoming crude drugs.
NOTE 1 The set-up of storage areas depends on the type of crude drugs stored.
c) Storage areas shall be laid out to permit effective and orderly segregation of the various categories of materials stored, and to allow rotation of stock. Different crude drugs shall be stored in separate areas.
d) Duration of storage of any crude drugs in unpacked form shall be kept to a minimum.
NOTE 2 Minimum duration of storage protect stored material, and reduce the risk of pest attacks.
e) Incoming crude drugs shall be processed, unless specified otherwise, as soon as possible and shall be stored at appropriate temperature to prevent bacterial and fungal growth.
f) Where materials are stored in bulk, to reduce the risk of mould formation or fermentation it is advisable to store them in aerated rooms or containers using natural or mechanical aeration and ventilation. These areas shall also be equipped in such a way as to protect against the entry of insects or animals, especially rodents. Effective measures shall be taken to limit the spread of animals and microorganisms brought in with the crude drug and to prevent cross-contamination.BS ISO 19617 pdf download.