Company Name Procedure Number: Page 3 of 9

Title: Implementation Date: Version Number

RETURNED DRUG PRODUCTS 1.0

1. Regulatory Basis, Reference Documents

• US Code of Federal Regulations 21 CFR, §211.204 “Returned Drug

Products” and §211.208 “Drug Product Salvaging”.
• WHO GMP for Pharmaceutical Products, Part 13 “Returned goods”.
• EU Guide to GMP for Medicinal Products, Part 5 “Rejected, Recovered
and Returned Materials”.
• FDA Draft Guidance for Industry “Manufacturing, Processing, or Holding
Active Pharmaceutical Ingredients” March 1998, Part 10 “Returned APIs
and Intermediates”, “API and Intermediate Salvaging”.

2. Purpose
Goods, which have left the control of the warehouse, should only be returned to
saleable stock if they are proven to meet products appropriate standards of
safety, identity, strength, quality or purity.

3. Scope
The purpose of this document is to describe the handling of goods returned from
the market to the warehouse or the distribution centre.

4. Responsibilities and Accountabilities

4.1 Returned Goods Manager

The returned goods manager is responsible that returned goods are assessed
and that this assessment is documented. The returned goods manager is also
responsible that the returned goods are separated from normal stock and that
these products are not returned to stock until approval by nominated Quality
person.

4.2 Quality Manager

Shall insure that the established procedure is being adhered. The assigned
Quality manager is responsible to approve only product that has been
successfully assessed is returned to stock.

5. Procedure

5.1 General
The handling of returned drug products generates a high expenditure to work and
should be decided on case-by-case basis if economically justified.1)

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