Manufacturing of Tablets & Capsules SOP

1.0 OBJECTIVE

To lay down the Procedure for Manufacturing of Tablets & Capsules.
2.0 SCOPE

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

3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY

HOD-Production/ Assigned Designee
5.0 PROCEDURE

5.1 PLANNING

The activities in 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.

5.2 OBTAINING THE BATCH DOCUMENT

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 form 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.

5.3 REQUISITION TO THE STORES

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.

5.4 ISSUE OF RAW MATERIALS TO MANUFACTURING DEPARTMENT

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

5.5 RECEIPT OF DISPENSED MATERIAL BY MANUFACTURING DEPARTMENT

Before taking the material into the area the production person shall ensure the cleanliness of the equipment & 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.

5.6 ASSIGNING MFG. DATE & EXP. DATE

5.6.1 The Mfg. The date should be assigned as per the date of dispensing.
5.6.2 The expiry date should be assigned as per the shelf life mentioned in BMR or considering the expiry date of active R.M.

5.7 PROCESSING

5.7.1 The material should be processed strictly as per BMR.
5.7.2 The operators should wear protective accessories like gloves, masks, muffs, ear plugs, goggles etc. while processing, as per the requirements.
5.7.3 Each equipment should have the status label with signature of the pharmacist.
5.7.4 Operators and pharmacists should check the area and equipment cleanliness before starting the manufacturing operations.
5.7.5 Environmental conditions like Temperature, Relative Humidity should be maintained within the limits specified in the respective BMR.
5.7.6 Pharmacist should ensure that, sieves 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.
5.7.7 Pharmacist should personally monitor all the critical operations like Dry mixing, Addition of binder, Wet mixing, Drying, Inlet and outlet temperature, Mixing time during lubrication, Machine setting, In process parameters etc.
5.7.8 The material ready for further processing should be immediately weighed and labeled accordingly and the weight should be recorded in the batch document.
5.7.9 All entries in BMR should be done immediately.
5.7.10 In process goods should be stored only in the area provided.
5.7.11 Standard Operating and Cleaning procedures should be strictly followed.
5.7.12 Any adverse incidence or spillage or deviation observed should be immediately informed to the superiors.
5.7.13 All the safety instructions should be strictly followed.

6.0 ABBREVIATIONS