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
6.1 SOP: Standard Operating Procedure
6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department