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for a drug product being returned implicates associated batches, an appropriate
investigation shall be conducted in accordance with the requirements of
211.192. Procedures for the holding, testing, and reprocessing of returned drug
products shall be in writing and shall be followed.

International GMPs

Chapter 3 Premises and Equipment
Storage Areas

3.18. Storage areas should be of sufficient capacity to allow orderly storage of

the various categories of materials and products: starting and packaging
materials, intermediate, bulk and finished products, products in quarantine,
released, rejected, returned or recalled.

Chapter 5 Production

5.65. Products returned from the market and which have left the control of the
manufacturer should be destroyed unless without doubt their quality is
satisfactory; they may be considered for re-sale, re-labeling or recovery with a
subsequent batch only after they have been critically assessed by the Quality

Control Department in accordance with a written procedure.

The nature of the product, any special storage conditions it requires, its
condition and history, and the time elapsed since it was issued should all be
taken into account in this assessment. Where any doubt arises over the quality
of the product, it should not be considered suitable for re-issue or re-use,
although basic chemical reprocessing to recover active ingredients may be
possible. Any action taken should be appropriately recorded.

Overview: Customer returns

Customers may return stock because it is oversupplied or incorrectly delivered.
However, it is not safe to assume that stock could be suitable for re-sale. There
is generally no way to tell whether the return has been tampered with, degraded

in transport or storage, or has been damaged in transit.

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