Sourcing of Starting Material in Pharmaceutical Industry
The purchasing process is pivotal. It should be handled by individuals who have an in-depth understanding of both the products and the suppliers.
Here are a 5 tips to keep your materials under control:
- Ensure to source materials from approved suppliers, ideally directly from the producer to maintain a high standard of quality.
- It’s non-negotiable to have quality agreements in place for all purchases, outlining the expectations and standards required from both parties.
- Risk management is vital; applying a level of oversight that is proportionate to the risk ensures safety and compliance at all stages.
- Don’t overlook the specifications; having detailed criteria for all materials is a fundamental requirement in securing quality.
Upon receipt of consignments, diligent checks are mandatory, including:
– The package integrity to ascertain there is no damage or tampering.
– Confirm the seals are intact, showcasing the product hasn’t been opened post dispatch.
– Cross-verify the details of the purchase order, delivery note, and supplier’s labels to ensure alignment.
– Employ clean containers and ensure labels maintain readability to facilitate clear and straightforward information transfer.
Adhering to these guidelines ensures a compliant and efficient process, safeguarding the quality of the starting materials.
Important points for GMP Starting Material
1. Manufacturers are responsible for any testing of starting material after it is produced.
2. Pharma companies can utilize partial or full testing from approved vendor but must, at a minimum, perform identification testing of each batch.
3. The rationale for outsourced testing must be documented, and additionally:
– Pay special attention to distribution controls
– Perform regular audits
– COA must be signed by a designated person
– Must wholly justify reduced testing
– Perform regular full risk-based analysis of material
4. Only QC-released starting materials within its shelf life should be used.
5. Dispensing must include the use of:
– Designated and appropriately trained personnel
– Written procedures on how to handle material
– Ensure that correct materials are accurately weighed into clean, properly labelled containers
6. Independent checks should be recorded, including details on material weight or volume.
7. Dispensed material for each batch must be kept together and labelled.
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