Care Intensive Drug BATCH MANUFACTURING

Page:1 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

1. Product Details
Xylocaine 2% jelly® (Lidocaine HCl 2% jelly)
Description Appearance: Clear, colorless, viscous gel, free from undissolved material
Dosage form: 30 g tube
Batch size: 600 kg
Batch Quantity Approx No. tubes: 20,000 tubes
Packaging Aluminum tube with a white cap
Preserve in tight containers, and store at controlled room temperature 20–25°C (68–
Storage Conditions
77°F). (USP).

2. Production Batch Record Issuance

Issued By – Issuer has reviewed the Batch Record to ensure that the copy is a complete, accurate copy of the
Master Batch Record.

(Print) Issued By – Quality Assurance Signature Date

Issued To – Production has reviewed the Batch Record to ensure that the copy is a complete and correct.
Production is responsible for the Batch Record following issuance.

(Print) Issued By – Quality Assurance Signature Date

3. Reference Documents
SOP – 007: Line Clearance
SOP – 010: Temperature and Humidity Monitoring
SOP – 011: Facility Cleaning Procedures
SOP – 015: Material Weighing and Dispensing

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Page:2 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

SOP–021: Gas Sterilization

SOP– 03: Aseptic Technique
4. Ingredients
Quantity Verified By
Component Required Exp. Date/ Performed
Code Lot No. Retest Date By / Date / Date
(kg)
A017 Lidocaine HCL 12 A545896-78

E045 hydroxypropyl 18 3546749-02

methylcellulose
E013 Methylparaben 1.08 7634646-89
E014 Propylparaben 0.12 2976565-76
E072 Sodium Hydroxide 0.12 9544567-88
E071 Hydrochloric acid 1.8 5657676-67

E002 Purified Water, USP 566.88 W10100-01

5. Processing Equipments
Cleaning Previous Calibration Performed By / Verified By
Equipment Description ID No. SOP Calibration Required Date / Date
Weighing Balance WB-01 011-01
Counter-rotating MX-03 011-06
Homogenizing Mixer
pH meter 011-05
QP-04
Filtration Units FU-01 011-021
Integrity test equipment QI-05 011-032

Batch No: Manufacturing Date : Expiry Date :

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Page:3 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

EO gas sterilizer GS-07 011-023

Gel filling machine MG-60 011-037

6. Area Clearance
Steps Performed signature Approved signature
by by
1. Review all applicable GMP Processing Area Logbook(s)
and verify that Cleaning has been performed according
to Facility Cleaning Procedures (SOP-011)

Date Cleaning Complete:

2. Review Section 4: Ingredients, and ensure that it is

complete, accurate, and that all necessary materials
are present for the operation.
3. Ensure that all Materials are Released, Approved and
have sufficient time to the Expiry Date
4. Review Section 5: Processing Equipment, and ensure
that it is complete, accurate, and that all necessary
equipment is present, cleaned and calibrated, as
appropriate.
5. Review the Logbook for each piece of Equipment,
and ensure that the Logbooks are correctly filled out.
Weighing Balance (WB-01):

Counter-rotating Homogenizing Mixer (MX03):

pH meter (QP-04):

Filtration Units (FU-01):

Integrity test equipment (QI-05):

EO gas sterilizer (GS-07):

Batch No: Manufacturing Date : Expiry Date :

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Page:4 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

Gel filling machine (MG-60):

6. Verify that the Production Area does not contain any

items from previous batches or cleaning activities and
that no items unrelated to the current batch are present.

7. Production procedure and records

Processing step Equipment Start Finish Performed Checked
By/ By/signature
signature
1. In Grade B, Dispensing room 1, ensure
room Temperature is within 22-24°C and
Humidity is less than 65%
Temperature:
Humidity:
2. In Grade B, Dispensing room 1 weight all Weighing
the ingredients separately into a suitable Balance
container/ plastic bag, and label each
container/bags with:
a) Name of material.
b) Lot No.
3. In Grade A, Sterilization room 1, ensure
room Temperature is within 22-24°C and
Humidity is less than 65%
Temperature:
Humidity:
4. Sterile HPMC through gas sterilization in EO gas
sterilization room 1 sterilizer

Batch No: Manufacturing Date : Expiry Date :

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Page:5 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

5. In Grade A, Mixing room 1, ensure room

Temperature is within 22-24°C and
Humidity is less than 65%
Temperature:
Humidity:
6. In Grade A, mixing room 1, transfer the
sterilized HPMC to the counter rotating
mixer (Vessel #1), using aseptic technique.

7. In Grade A sterilization room 1, Filter half Filtration

amount of the purified water ( About 200 Units
kg) through 0.2 micron cellulose filter

8. Checked the integrity of the sterilized Integrity

filter using bubble point test
8.1. Record: equipment
Filter number:
Filter Lot number:
8.2. Wet the filter to be tested with water.
8.3. Place the wetted filter in
the appropriate housing.
8.4. Connect the outlet fitting from the
compressed air pressure regulator to
the upstream side of the test filter.
Check that the gauge which is
connected to the pressure regulator
has subdivisions of at least 0.5 psig,
and has the capacity to measure up
to 100 psig.
8.5. Connect the outlet fitting from the
compressed air pressure regulator
to the upstream side of the test
filter.
8.6. Connect a piece of flexible tubing
from the downstream port of the test
filter into a beaker filled with water.
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Page:6 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

8.7. Starting from zero pressure,

gradually increase the pressure to the
test filter using the pressure regulator.
8.8. Observe the submerged end of the
tubing for the production of bubbles
as the upstream pressure is slowly
increased in 0.5 psig increments.
Note the rate that the bubbles appear
for the end of the submerged tube.
8.9. The bubble point of the test filter is
reached when bubbles are
produced from the tube at a steady
rate.
8.10. Record the pressure to the nearest
0.5 psig as indicated on the pressure
gauge.
Pressure:
8.11. If the recorded pressure is greater
than or equal to the minimum
expected bubble point 50 psig, the
filter is integral. If the recorded
pressure is lower than the
minimum bubble point listed
above, the filter has failed the
integrity test.
Result:
9. In Grade A mixing room 1, transfer the
sterilized water to the counter rotating
mixer (Vessel #1) that containing HPMC.
Using aseptic technique
10. Dissolve HPMC in water for 5 counter
mins: Speed: rotating
mixer
11. In Grade B, in mixing room 1, ensure
room Temperature is within 22-24°C and
Humidity is less than 65%
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Page:7 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

Temperature:
Humidity:
12. In Grade B, in mixing room 1, transfer, less
than half amount of water, lidocaine HCL,
Methylparaben and propylparaben to the
counter rotating mixer (Vessel #2)

13. Dissolve all ingredients in counter rotating counter

(vessel #2) for 5 min: rotating
Speed: mixer

14. In Grade A, Sterilization room 1, filter the Filtration

solution from Vessel #2 through 0.2 Units
Micron cellulose.

15. Checked the integrity of the sterilized filter Integrity

using bubble point test
(refer to point 8 in the record) equipment
Filter number:
Filter Lot number:
Pressure:
Result:

16. In Grade A, Mixing room 1, transfer the

filtrated solution to counter rotating
(vessel #1), using aseptic technique.

17. Mix for 5 mins: counter

Speed: rotating
mixer
18. In Grade A, Sterilization room 1, filter Filtration
hydrochloric acid and sodium hydroxide Units
through 0.2 micron.

Batch No: Manufacturing Date : Expiry Date :

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Page:8 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

19. Checked the integrity of the sterilized filter Integrity

using bubble point test
(refer to point 8 in the record) equipment
Filter number:
Filter Lot number:
Pressure:
Result:
20. In Grade A, Mixing room 1, add counter
hydrochloric acid and sodium hydroxide to rotating
the mixture in counter rotating Vessel #1 mixer,
to adjust the pH to (6.0-7.0) pH Meter
21. In Grade A, Sterilization room 1, filter the Filtration
rest amount of purified water Units

22. Checked the integrity of the sterilized filter Integrity

using bubble point test
(refer to point 8 in the record) equipment
Filter number:
Filter Lot number:
Pressure:
Result:
23. In Grade A, Mixing room 1, add filtered counter
water to the mixture in counter rotating rotating
Vessel #1 and adjust the final weight of the mixer
batch to 600 kg
24. Take sample for QC test (visual inspection,
assay, viscosity)
25. In Grade A, Filling room 1, ensure room
Temperature is within 22-24°C and
Humidity is less than 65%
Temperature:
Humidity:
Monitor both Temperature and Humidity
every 30 mins until end of filling Process

Batch No: Manufacturing Date : Expiry Date :

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Page:9 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

Time Temperature Humidity

(°C) (%)

26. Transfer the final mixture from Vessel #1

to gel filling machine in area A, filling
room 1. Using aseptic technique.
27. Run gel filling machine (SOP–021), using Gel Filling
pre-sterilized tube, set the speed of Machin
filling: Speed:
28. Perform minimum fill test: Weighing
28.1. Select a sample of 10 filled Balance
containers, and remove any labeling
that might be altered in weight
during the removal of the container
contents.
28.2. Thoroughly cleanse and dry the
outside of the containers by a
suitable means, and weigh
individually.
28.3. Quantitatively remove the contents
from each container, cutting the
latter open and washing with a
suitable solvent, if necessary
28.4. Taking care to retain the closure
and other parts of each container.
Dry, and again weigh each empty
container together with its
corresponding parts.
28.5. The difference between the
two weights is the net weight
of the contents of the
container. Result:
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Page:10 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

29. Continue filling tubes and check the

minimum fill again at the end of the
process.
Result:

30. At the end of the run perform cleaning

according the cleaning SOP- 011-037.

31. Grade D, Packaging room 1, ensure room

Temperature is within 22-24°C and
Humidity is less than 65%
Temperature:
Humidity:
Monitor both Temperature and Humidity
every 30 mins until end of packaging
Process

Time Temperature Humidity

(°C) (%)

32. Transfer filled tubes to packaging room 1,

for packaging and labelling (see Packaging
Instructions & Record)

8. Sampling, material transfer& storage

Batch No: Manufacturing Date : Expiry Date :

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Page:11 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

9. Yield Calculation

Yield
= 100 % xFilled quantity Weight of Raw Materials
=(Specification: 95 - 100 %)

Finished Product Yield

= 100%xFilled quantity –(total rejection Rejects + Samples)
Filled quantity

=(Specification: 90 - 100 %)

10. Post-Production Review

The complete Post-Production Batch Record has been reviewed for completeness and accuracy. All pages are
complete and all entries conform to Good Documentation Practices.

Name Signature Date

Production

Batch No: Manufacturing Date : Expiry Date :

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Page:12 of 12
pharmaceutical company INSTRUCTIONS AND RECORD

Title : Batch Record :

Department : Xylocaine 2% jelly® (Lidocaine HCl 2% jelly) BMR-001
Production
Name Signature Date
Revision No. :
Prepared by
0
Production Manager
Approved by Effective Date :
22/4/2020
QA Manager

Quality Assurance

Batch No: Manufacturing Date : Expiry Date :

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