QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 504

abc Pharmaceutical comPany

ANNEXURE D (FOR STERILE)
STERILE BULK MANUFACTURING FACILITY
SELF-EVALUATION QUESTIONNAIRE

7th Packaging/Shipping Yes No N/A

1. Are the shipping containers sufficiently marked to identify content,

storage condition, lot number, country of origin, quantity, and expiration

date, if applicable?   

2. Are expiration dates based on current stability data?   

3. Are shipments adequately protected from in-transit damage?   

4. If drums are recycled from clients, are they cleaned via a validated

procedure?   

5. Is there a formalized procedure to inspect and clean by validated

method for drums before filling for shipment?   

6. Are storage tanks dedicated for specific chemicals?   

7. Does the company include a certificate of analysis with the shipment?   

8. Does the company include a packing list with the shipment?   

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