This SOP for Production Planning and Batch Record Review is for assigning individual responsibilities to Q.A and Production with regard to proper entries and completion of batch records in time to ensure batch product release. This SOP for Production Planning and Batch Record Review the documented procedure for points to be checked by QA during batch record review.

PURPOSE:

To describe the procedure for production planning and batch record review.

SCOPE:

This procedure is for Quarterly / Monthly & Fortnightly / Weekly production planning of all sections of the Production Department and the documented procedure for points to be checked by QA during batch record review.

RESPONSIBILITY:

Production Manager.
Production Pharmacist.

Head of the Production Department

REFERENCES:

In-house.

PROCEDURE:

1. Manager Admin. gets Monthly/Quarterly/Annual sales forecast from Sales & Marketing department and (after evaluating finished goods stock, in-process stock, physician samples requirement) prepares monthly production orders with the coordination of Warehouse Incharge and after approval from Director Plant, forwards monthly production orders to Production Manager for production planning.
2. Prod Manager prepares the Tentative Fortnightly / Weekly Production Plan for each section, after evaluating monthly production orders and sends to Director plant for approval.
3. Director plant approves the Tentative Weekly / Fortnightly Production Plan.
4. After approval, Production Manager sends the copy of Weekly/Fortnightly production plan to the Management and all concerned Departments (Production, Sales & Marketing, Material Management, and QA/QC).
5. Section Incharge / Pharmacist with the coordination of Prod. Manager execute the Tentative Fortnightly / Weekly Production Schedule on daily basis, keeping in view the priority from Sales & Marketing Department and in-house stock.
6. Section In-charge / Pharmacist execute the Production as per plan and any pending products are carried forward to the next fortnightly / weekly production plan (if needed).
7. Any change or amendment in Monthly production orders due to market demand from Sales & Marketing Department is communicated through E-mail and then after approval from Director plant, revised Monthly production order will be sent to Production department by the Manager Admin. department.

General checks:

1. Records are error free, tidy, legible and accurate.
2. Good quality of photocopy.
3. The timing of each process is sequential with procedure in BMR.
4. Any overwriting/ cancellation of entry should be signed by responsible officer.
5. Any deviation in process should be mentioned in batch summary sheet. Q.A to ascertain impact on product quality at the time of review before product release.

Work order:

1. Duly authorized & signed.
2. Item code/ Q.C number filled against each item.
3. Correct calculation of gross/ tare/ net weight.
4. Reconcile any excess issues/ returns in work order.
5. Ensure each item issued has two signatures of weighed by & checked by.
6. Ensure batch material issue/ receipt, signature of responsible officers.

BMR Checks:

1. Cleanliness record is entered for both equipment and areas.
2. Equipment code numbers.
3. Previous product details.
4. Cleanliness checked by signature.
5. Line clearance certification for all operations signature of Q.A.
6. Operation timings and name of operators are entered.
7. Ensure critical operations are counter checked by second person.
8. Verify proper timings of in-process control.
9. Input/ output materials reconciliation yield of final product at each stage is within limits.
10. Check for proper Q.C reports.
11. Check batch summary sheet for deviation recording and authorization.

BMR:

1. Work order sheet: Checked the standard Quantity/Quantity issued. Ensure the individual key material quantity, Q.C. number of all packing materials.
2. The complete batch record after review and corrections will be approved by quality assurance. These records will be in safe custody of quality assurance.
3. Following attachments required to be attached to batch manufacturing record before submitting the completed BMR to Quality Assurance.
4. Equipment clean record (rinse reports).
5. Raw materials dispensed weighing slip.
6. Intermediate raw material sealed.
7. Transfer note for finished goods to F.G store.
8. IPQC-In Process Test Request Cum Report.
9. Deviation note if any.
10. Certificate of analysis. (COA)
11. Finished product dispatch data.