sop of Reconciliation of raw materials & packaging materials
- Objective:To provide a procedure for reconciliation of raw materials & packaging materials.
- Scope:This SOP is applicable to all raw material & packaging material available in the warehouse of formulation plant at (Pharmaceutical Company Name).
- Responsibility:Raw Material & Packing Material Store personnel shall be responsible for reconciliation of raw & packing material.
- Accountability:Concerned Department Head and QA Head shall be accountable for implementation of this SOP.
- Abbreviations and Definitions
IPQA – In-process Quality Assurance
FIFO – First in first out
FEFO – First Expiry first out
RM – Raw Material
QA – Quality Assurance
BMR – Batch Manufacturing Record
- For each item there will be individual account in stock register for raw material and for packaging materials.
- After receiving all the materials and entering in the Raw and Packaging material incoming register with supply details, the Stock of each item will be entered in stock register of raw and packaging materials.
- Before issuing the materials confirm the balance quantities of A.R. No. from the stock register of raw and packaging materials.
- FIFO rules should be followed while issuing Packaging materials and in case of Raw materials FEFO rule should be followed.
- After completing all the process of issuance make entries in register as per store copy of BMR & BPR.
- The last column of stock register in each account will show the total balance qty of each material.
- Forms and Records (Annexures): Not Applicable
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Stores.
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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