Standard Operating Procedure (SOP) for Review of General SOP for Batch Processing in the pharmaceutical manufacturing industry. A detailed checklist for review of General SOP for Batch Processing for Draft Copy as well as Filled Copy of Batch Manufacturing/Packing Records. this SOP is to define the procedure to review the draft General SOP for Batch Processing prior to final approval. Also, this SOP shall be applicable for a review of executed BMR prior to the final release of batches.

PURPOSE :

To lay down the procedure for manufacturing Tablets and Capsules.

SCOPE:

This SOP shall be applicable for Tablet & Capsule Manufacturing in the Production department.

RESPONSIBILITY:

1 Execution: Production Pharmacist.
2 Checking: Production Manager.
3 Q.A Officer.

REFERENCES:

In-house.

PROCEDURE:

Planning:

1. The activities in the manufacturing department should be planned according to the production schedule by Production Executive or Production Manager for the respective month, and specifically for the respective week.

Obtaining the Batch document:

1. According to plan production person shall generate Process order no. of respective products and obtained the batch no. and batch documents from Q.A. department, for this a request is to be raised to Q.A. department mentioning the Product name and Process order no. as required. After the generation of the batch documents by Q.A. department, the production department should receive it from Q.A. department duly signed by Q.A. Officer. The production person should also sign while receiving the document after checking the pages, issue no., batch details, etc.

Requisition to the stores:

1. The raw material requisition/ Bill of material should be raised preferably in advance, to issue of the raw materials for respective batches. The store person should make necessary arrangements for the dispensing accordingly.

Issue of Raw materials to Manufacturing Department:

1. The stores officer, Production officer along with Q.A. officer if required should weigh the raw materials as per the standard operating procedure for dispensing. After weighing, the raw materials will be stored in suitable container, in Day Store it will taken for production. The duly filled requisition/Bill of material and BMR will remain along with the dispensed raw materials.

Receipt of Dispensed material by Manufacturing Department:

1. Before taking the material into area the production person shall ensure the cleanliness of the equipments & area and get the line clearance from Q.A. person. Then take the raw material into the respective manufacturing area and all the weighed materials will be checked against the requisition with calibrated balance. Also the other details on dispensing label like product name, material name, batch no., lot no., etc. will be checked.

Assigning Mfg. Date & Exp. Date:

1. The Mfg. Date should be assigned as per the date of dispensing.
2. The Exp. Date should be assigned as per the shelf life mentioned in BMR.

Processing:

1. The material should be processed strictly as per BMR.
2. The operators should wear protective accessories like gloves, masks, muffs, ear plugs, goggles, etc. while processing, as per the requirement’s.
3. Each equipment should have status label with signature of pharmacist.
4. Operators and pharmacists should check the area and equipment’s cleanliness before starting the manufacturing operations.
5. Environmental conditions like temperature, relative humidity should be maintained within the limits specified in the respective BMR.
6. Pharmacist should ensure that, sieve and screens are intact before and after the processing. When any new sieve is received, it should be checked for its mesh size by counting no. of perforations per linear inch. The mesh size should be checked against the sieve no. punched on the edge of the sieve.
7. Pharmacist should personally monitor all the critical operations like dry mixing, addition of binder, wet mixing, drying, inlet and outlet
8. temperature, mixing time during lubrication, machine setting, in process parameters, etc.
9. The material ready for further processing should be immediately weighed and labeled accordingly and weight should be recorded in batch document.
10. All entries in BMR should be done immediately.
11. In process goods should be stored only in the area provided.
12. Standard operating and cleaning procedures should be strictly followed.
13. Any adverse incidence or spillage or deviation observed should be immediately informed to the superiors.
14. All the safety instructions should be strictly followed.