Pharmaceutical Guidance Complete Pharma Solution
Issue of additional Raw and Packaging materials
- Objective:To lay down a procedure for issuing additional raw and packing material to the Production Department.
- Scope:This SOP is applicable for issuing additional raw and packing material to the Production Department at (Pharmaceutical Company Name).
- Responsibility:Warehouse personnel shall be responsible for issuing additional raw and packing material to the Production Department.
- Accountability: Concerned Department Head and QA Head shall be accountable for implementation of this SOP.
- Abbreviations and Definitions
QA :Quality Assurance
SOP :Standard Operating Procedure
- Procedure:
- The Additional Raw and Packing material shall be issued to production department under following circumstances:-
- On line Rejection.
- Re-Processing.
- Spillage and Wastages of Materials during transit and production.
- Production Department shall raise a requisition in the form of “Supplementary Slip in Duplicate for Raw and Packing Materials”.
- This Requisition shall be authorized by Head-QA after investigating the Requirement of additional material.
- After receiving the “Supplementary Slip for Raw and Packing Materials” from production department, material should be dispensed as per its SOP.
- While dispensing the additional material, it shall be assured that the material being issued is approved.
- The detail of the additional materials issued shall be recorded in “Supplementary Slip for Raw and packing Materials”.
- Keep the store copy for Record and hand over the production copy to production department.
- Record the issue detail in stock ledger.
- The Additional Raw and Packing material shall be issued to production department under following circumstances:-
- Forms and Records: Not Applicable.
- Distribution
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance & Production
- History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube
