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SOP for Batch Manufacturing Procedure

OBJECTIVE
To lay down a procedure for batch manufacturing.

SCOPE
This procedure applies for production department in Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY
The production staff is responsible for 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 using 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 Warehouse In-Charge who shall prepare for the issuance of the following day.
  • On the day of production, all equipment used for 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 absence of traces of the previous product and packaging material and the findings documented.
  • On receipt of material’s requisition, the Warehouse In-Charge shall check the stock position and fill the relevant details in the material issue slip and invite production and Q.A. for the dispensing.
  • All raw materials shall be issued in presence of production and QA personnel and the 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 to batch size and the remaining after getting the actual yield where necessary.
  1. Any excess labels shall be destroyed in 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 production manager 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 area 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 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 ready for distribution.
  • Production shall continue only when Q.C. department has approved the in-process material if it fails 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 in 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 Q.A. department.
  • Q.C Department is responsible for analysis and release the product.
  • The analytical documents shall send to Q.A. Manager for review before releasing the batch.
  • The B.M.R shall be sent to 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(s)
Q.A : Quality Assurance
SOP : Standard Operating Procedure
No. : Number
P.D : Production
B.M.R : Batch manufacturing record

ANNEXURE(s)
Nil.

REVISION CARD
Nil.


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