- Objective:To lay down a procedure for Requisition, Receiving and Counter Checking of issued Raw Materials.
- Scope :This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company.
- Responsibility:
- Trained Worker / Operator shall be responsible for performing the procedure as per this SOP.
- Production Supervisor / Officer shall be responsible for implementation of this SOP.
- Head-production / designee shall be responsible for compliance of this SOP.
- Accountability:
- Head-production / designee shall be responsible for compliance of this SOP.
- Abbreviations and Definitions:
- BMR – Batch Manufacturing Record.
- Standard Quantity – Quantity of drug recommended in Technical Directions. It is based on assay 100.0% and LOD or water content 0.0%.
- COA – Certificate of Analysis.
- LOD – Loss on Drying.
- API – Active Pharmaceutical Ingredient.
- IPQA – In-Process Quality Assurance.
- RM – Raw Material.
- A.R. No. – Analytical Report Number.
- IPC – In-Process Container.
- SOP – Standard Operating Procedure.
- TD – Technical Direction.
- Procedure:
- Request shall be sent to raw material store on ‘Available Approved Active Drug Form’ as per Annexure-I.
- Copies of testing dockets and COAs for the batch planned shall be given to production alongwith the filled ‘Available Approved Active Drug Form’ (Annexure-I).
- After receiving the copy of ‘Available Approved Active Drug Form’ filled from store, calculations shall be done for required active drug as per the formula given in BMR with the ‘standard quantity’ of the drug given for the batch by the production person. For the ease in calculation, Calculation factor given in testing docket by QC shall be used. Write details of calculated quantities in the columns provided on the weighment sheet or on the back side of the weightment sheet.
- Calculations for drug and shelf life given to the batch shall be counter checked by other production personnel and thereafter by IPQA personnel and shall be stamped as per following.
| CALCULATION : DATE OF EXPIRY :
CHECKED BY : WITH API : CHECKED BY PRODUCTION…IPQA: PRODUCTION…IPQA: |
Note: In case, the API quantity calculated for addition into particular batch is below the recommend quantity or standard quantity because of assay of API is more than 100%, then quantity for addition of API shall be standard quantity as recommended in weighment sheet of technical direction.
- Fill the weighment sheet with all the required information on it. Write the required material in lots as required in BMR e.g. A 200.0 Kg material of an ingredient for making four lots, shall be required to be issued as 4 x 50.0 Kg.
- Weighment sheet (Requisition for dispensing of batch) shall be duly checked and signed with date and thereafter shall be submitted to raw material stores for dispensing. Attach all the copies of dockets and COAs of active drugs in respective BMR.
- After complete weighing, IPC bin(s) shall be labeled properly and material shall be brought to batch staging area through outer corridor and bin(s) shall be placed batch wise.
- Precaution shall be taken that the dispensed raw material shall not be kept for more than seven days. Paste the label on dispensed material cage bin.
- If however, the dispensed raw material is kept for more than seven days, deviation shall be raised as per Annexure-III and ensured that material shall be used within 14 days from the date of dispensing.
- All the details regarding the dispensed raw material i.e. storage conditions, Batch no., dispensing date, execution date. etc. shall be recorded in per Annexure- III.
- The Empty hard gelatin capsule shell and coating material which may not be consumed within 7 days of dispensing may be dispensed separately or as when required.
- Before starting the manufacturing process each material is to be checked for its Item Name, Specification, Product Name, Batch Number, A. R. No. and Gross Weights with calibrated balance and if everything is ok then production person shall sign with date on its tag.
- Any online rejection of raw material to be recorded in “Line Rejection Note” (Annexure-III) signed by Production Supervisor / Officer and IPQA and then return to the Raw Material Store. The returned quantity shall be replaced with approved raw material.
- Forms and Records
- Available approved active drug form – Annexure-I
- Line Rejection Note – Annexure-II
- Requisition for time enhancement of dispensed raw material –Annexure-III
- Distributions
- Master Copy – Documentation Cell (QA)
- Controlled Copies – Production, Quality Assurance, Stores and Quality Control
- History
| Date | Revision
Number |
Reason for Revision |
| – | 00 | New SOP |
Annexure-I
|
AVAILABLE APPROVED ACTIVE DRUG FORM |
|||||||||
| To be filled in by Production Department
(Production Officer / Executive) |
To be filled in by RM Stores
(Officer / Executive) |
||||||||
| From: Production | To: RM Store | From: RM Store | To: Production | ||||||
| Kindly let us know the available,approved active drug in RM Store for Division : | Details are given below :
|
||||||||
| Product | No. of batches | Batch size | Approved | A.R. No. | Qty. | Expiry date | Remarks | ||
| Signature / Date
(Production Officer / Executive) |
Signature / Date
RM Store Officer / Executive |
||||||||
| Remarks : Photocopies of the COA (s) and docket (s) of the above are enclosed. | |||||||||
Annexure-II
|
LINE REJECTION NOTE |
|||||||
| DOCUMENT NO. | B.NO. | ||||||
| PRODUCT NAME :______________ | MFG. DATE__________ _______________ | EXP. DATE ___________ | |||||
| ITEM
CODE |
ITEM DESCRIPTION
|
UNIT | A.R. NQ.
|
QTY
ISSUED |
QTY
REJECTED |
||
| Reason for Rejection : | |||||||
| Production
(Prepared By 🙂 |
IPQA
(Checked By) |
(Store)
Received by |
|||||
Annexure-III
Requisition for time enhancement of dispensed raw material
Product Name:…………………… Product Code:……………..
Batch No.:………………………… Market:……………………
Dispensing Date:…………………. Execution Date:……………
(A)Check List
| S. No | Checklist | Status |
| 1 | It is ensured that dispensed raw material is stored under lock and keys in raw material storage cabinet with dispensed material storage label. | |
| 2
|
It is ensured that dispensed raw material is stored under control environment condition | |
| 3 | It is ensured that raw material is found satisfactory after reviewing the temperature and relative humidity condition as per recording in the format. | |
| 4 | It is ensured that material stored properly with status label. | |
| 5 | If the dispensed material not used within seven days from the date of dispensing, after reviewing all the parameter or environmental condition it shall be ensured that material shall be used within 14 days from the date of dispensing. | |
| NOTE: Tick mark (Ö ) – Completion of jobs as per instruction, Cross mark (x) –Incomplete or incorrect job done | ||
| (Sign/ Date) (Sign/ Date)
Concerned Dept. IPQA |
||
(B)Investigation / Finding / Reason if dispensed material not used within 14 days (Attach extra sheet if required)
(Sign/ Date) (Sign/ Date) Dept. Head QA Head
(C) Justification if dispensed material not used within 14 days
(Sign/ Date) (Sign/ Date) Dept. Head QA Head
(D) Any additional testing required, if dispensed material not used within 14 days( if any)
(Sign/ Date) (Sign/ Date) Dept. Head QA Head
(E) QA Comments for further Process, if dispensed material not used within 14 days
(Sign/ Date) QA Head
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