SOP for Batch Manufacturing Procedure

OBJECTIVE

To lay down a procedure for batch manufacturing.

SCOPE

This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY

The production staff is responsible for the implementation of the process.

The production In-Charge / Q.A Supervisor is responsible for the execution and compliance of the procedure.

PROCEDURE

• All production shall be carried out with purified water BP grade; equipment & utensils shall be rinsed with purified water before use for production.
• One day in advance, the Beta-Lactam In-Charge shall write a requisition for all materials required for production.
• After the Pharmacist in-charge has authorized material issuance, the requisition shall be sent to the Warehouse In-Charge who shall prepare for the issuance of the following day.
• On the day of production, all equipment used for the production of that particular drug product shall be checked for proper calibration, maintenance, and cleanliness and the findings documented. The whole production line shall be checked for the absence of traces of the previous product and packaging material and the findings documented.

• On receipt of the material requisition, the Warehouse In-Charge shall check the stock position fill in the relevant details in the material issue slip, and invite production and Q.A. for the dispensing.
• All raw materials shall be issued in the presence of production and QA personnel and together with Warehouse In-Charge and the person weighing shall endorse the raw material slips.
• Labels & other packaging materials shall also be issued a day in advance of packaging so as to give ample time for the over-printing of batch number, expiry, and manufacturing dates.
• Labels shall be printed in accordance with the batch size and the remaining after getting the actual yield where necessary.

1. Any excess labels shall be destroyed in the presence of the supervisor and reconciliation of labels for that batch shall be made on the store bin card and on the B.M.R.
2. The printing machine shall be set for the correct batch number, manufacturing date, and expiry date and the first label printed shall be checked by the production manager and then Q.A. Personnel who shall endorse it.
3. Production shall commence upon assembling of all materials and production records in the department.
4. All utensils, equipment, and manufacturing areas shall be appropriately labeled with the in-process label at any particular stage of production.

• For each ingredient, there shall be at least one person to perform and another to cross-check & then document addition.

1. At critical stages, i.e. quality determining stage, sampling will be done by the Q.A. department for testing and documenting.

• In Tablets, samples shall be drawn at the following stages:

1. After granulation/Blending.
2. During compression.
3. When the drug product is in its final pack ready for distribution

• In capsulation/ Dry syrups, samples shall be drawn at the following stages:

1. After mixing.
2. During filling.
3. When one product is in its final pack and ready for distribution.

ALSO READ: SOP for Correction of wrong entry in BMR

• Production shall continue only when the Q.C. department has approved the in-process material if it fails the test, the material shall be reworked and re-tested.
• After completion of each stage of manufacture, the batch records together with labels shall be sent to the next stage until the process is completed.
• At the end of batch manufacturing, all the machines, utensils and the area shall be cleaned and then checked.
• At the end of packaging, all machines, utensils, and the area shall be cleaned of all drug products and packaging material. The line clearance shall be documented.
• After packaging a reconciliation of the yield shall be made. This shall not be less than 95% and not more than 100% otherwise an investigation will be done to determine the cause of unusual deviation from the acceptable limits, the results of which shall be documented.
• At the end of production, the Beta-lactam In-Charge shall complete the production documents and together with all the labels send the documents to the Q.A. department.
• Q.C Department is responsible for the analysis and release of the product.
• The analytical documents shall be sent to the Q.A. Manager for review before releasing the batch.

• The B.M.R shall be sent to the Q.A. manager for review before releasing the batch.
• The reviewed and approved record shall be kept for a period of one year after the expiry date of the product.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No. : Number

P.D: Production

B.M.R: Batch manufacturing record

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: Why is it Necessary to Produce in Batches and Use Batch Numbers?