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International GMPs

Procedures and records

4.19, There should be written procedures and records for the receipt of each
delivery of each starting and primary and printed packaging material.
4.20. The records of the receipts should include:
a) the name of the material on the delivery note and the containers;
b) the "in-house" name and/or code of material (if different from a);
c) date of receipt;
d) supplier's name and, if possible, manufacturer's name;

e) manufacturer's batch or reference number;
f) total quantity, and number of containers received;
g) the batch number assigned after receipt;
h) any relevant comment (e.g. state of the containers).

Chapter 8
Complaints and Product Recall

8.13, The distribution records should be readily available to the person(s)
responsible for recalls, and should contain sufficient information on wholesalers

and directly supplied customers (with addresses, phone and/or fax numbers
inside and outside working hours, batches and amounts delivered), including
those for exported products and medical samples.

Overview

GMP rules require that companies have starting materials and finished product
traceability all along the supply chain. This is achieved by accurate recording in
official records and registers, the movement of all materials and products at all
stages of the product cycle.

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