| Title: Raw Materials (RM) and Packaging Materials: Receipt | |||||
| Guidance Number: 076 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Raw Materials (RM) and Packaging Materials: Receipt
Introduction
This document provides guidance for receipt and storage of raw materials (RM), components, and packaging materials used in the manufacture and packaging of active pharmaceutical ingredients (API), drug products, and medical devices.
1. Prior to Unloading a Shipment, examinations and inspections should be conducted to verify that:
- The shipment matches quantities and materials ordered (by comparison of the purchase order with the packing slip or delivery note);
- Observable onboard materials appear properly labeled and free from apparent damage or contamination;
- For bulk raw materials received in bulk carriers, verification that tamper-evident seals are in place and intact on all openings or locations as defined in a Site Standard Operating Procedure (SOP) and on capped discharge lines. Tamper-evident seals are not required on pressurized bulk carriers. Where shipping documents include the identification numbers of the tamper-evident seals, the numbers should be verified against those on the seals; and
- If the bulk carrier may also be used for transport of other bulk raw materials (i.e., non-dedicated carrier), evidence of cleaning (e.g., certificate of cleaning) from the prior load should be provided.
2. Actual Shipment Quantities should be verified against those recorded on the packing slip or delivery note either during or immediately after unloading.
3. Supplier Labels on each container or group of containers should describe the exact material ordered (including grade, if applicable) and the supplier lot number, if available. The supplier labels should be verified during or immediately after unloading. If a label containing the site in-house material code is applied by the supplier, the label should also be verified during or immediately after unloading.
If the supplier does not apply a label containing the site in-house material code, these codes should be applied in-house upon receipt.
4. A Quarantine Status should be assigned to materials meeting the following requirements and the materials stored accordingly:
- Container seals are intact;
- Containers do not appear to be damaged;
- Free from apparent contamination;
- The proper material is correctly identified; and
- The correct quantity, according to the matching site purchase order.
Materials not meeting these requirements should not be accepted. The Site Quality Team should be immediately notified and should determine whether to have the material returned to the Non-Site supplier or to assign it a Quarantine-hold status.
5. Purchasing and Receiving Procedures should specify that only production materials on a list maintained and approved by the Quality Team may be purchased and received for production use.
6. Materials Brought to the Site for Evaluation or Experimental Purposes only should be segregated following Site SOPs to prevent their use in production.
7. Production Materials Not Received as Specified in Purchasing Documents should be assigned Quarantine-hold status.