by - OBJECTIVE
To describe the procedures for in -process check during various stages of product manufacturing.
- SCOPE
This SOP is applicable for in process check during various stages of product manufacturing till packing .
3.0 RESPONSIBILITY
Production Chemist & operator : To follow the procedure
4.0 ACCOUNTABILTY:
QA & Head Production : For system compliance
- PROCEDURE
Following in-process parameters are to be checked and recorded.
5.1 Gelatin mass storage tank temperature:
5.1.1 Check the temperature of the gelatin mass from storage tank with the help of calibrated Temperature indicator during operation.
5.2 Reactor temperature:
5.2.1 Check the temperature of the gelatin mass from reactor with the help of calibrated temperature indicator during operation.
5.3 Gelatin mass vacuum pressure gauge:
5.3.1 Check the gelatin mass vacuum pressure in reactor with the help of calibrated gauge indicator during operation.
5.4 Medicament jacketed storage tank:
5.4.1 Check the medicament jacketed storage tank physically in case of medicament hold after manufacturing.
5.5 Medicament vacuum pressure gauge:
5.5.1 Check the medicament vacuum pressure in medicament tank with the help of calibrated gauge indicator during operation.
5.6 Encapsulation machine segment temperature:
5.6.1 Check the temperature of the segment with the help of calibrated digital temperature indicator.
5.7 Encapsulation machine spreader box temperature:
5.7.1 Check the temperature of spreader box left & right side with the help of calibrated digital temperature indicator.
5.8 Gelatin ribbon thickness:
5.8.1 Check the ribbon thickness of left and the right side with the help of calibrated thickness measure gauge.
5.9 Encapsulation machine drum’s temperature:
5.9.1 Check the temperature of machine drum with the help of calibrated digital temperature indicator.
5.10 Weight variation:
5.10.1 Check and ensure the weighing balance is calibrated.
5.10.2 Take the capsules from encapsulation machine as per number of orifice (syringe).
5.10.3 Wash the capsule in isopropyl alcohol (IPA) to remove oily residue from outer surface and dry with cloth.
5.10.4 Set the zero indication on balance and put one capsule on the pan. Note the reading of capsule as gross weight in BPCR.
5.10.5 Cut the capsule and take off the medicament from shell. Wash the capsule shell with IPA.
5.10.6 Weight the empty shell and record it as shell weight in BPCR.
5.10.7 Deduct the empty shell weight from gross weight and record the result as fill weight of capsule in BPCR.
5.10.8 Take the weight of remaining capsule as per procedure 5.10.4 to 5.10.7.
5.10.9 Find out the average fill weight. Ensure the individual fill weight and average fill weight are within specified limit.
5.10.10 Adjust the machine if it is out of limit and repeat the weight variation. Repeat the weight variation for batch after every two hour.
5.11 Encapsulation air pressure gauge:
5.11.1 Check the air pressure in ribbon cutting in two die rolls with the help of calibrated air pressure gauge.
5.12 Blister machine sealing heater temperature:
5.12.1 Check the temperature of the sealing heater with the help of calibrated digital temperature indicator.
5.13 Blister machine forming temperature:
5.13.1 Check the temperature of the forming heater with the help of calibrated digital temperature indicator.
5.14 Blister machine air pressure gauge:
5.14.1 Check the air pressure in cavity forming with the help of calibrated air pressure gauge.
5.15 Leak-test:
5.15.1 Perform leak-test of the drug product after primary packing.
5.16 Frequency:
5.16.1 Record the above parameter in BPCR of respective product as per the relevant of frequency mentioned in the BPCR/SOP.
6.0 TRAINING
Trainer : Head – Production Department
Trainees : Staff and machine operator of production and QA chemist.
7.0 DISTRIBUTION
Master Copy : QA Department
Controlled Copy : Production Department
Display Copy : Production Department (If Required)
8.0 ATTACHMENTS
Nil.
- REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
