BRIYOSIS

Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara

BATCH MANUFACTURING AND PACKING RECORD
MASTER BMR No.: BMPR/BP/2129
Product Name : SILYMARIN +VITAMIN B COMPLEX Page No. 01 of 33
CAPSULES
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES
Master Formula Batch No. : Standard Batch Size:
Ref. No. : MFR/BP/2129 Caps.
Effective Date : 06/07/2016 Mfg. Date : Batch Size :
Review on : 05/07/2018 Exp Date : Theoretical Yield : 96.00%
Product Code : BP-2129 Issued By : Standard Yield: Caps
Mfg. Lic No. : G/25/1725 Issued Date : BMR SR. NO.
Std. Shelf Life : 24 Months Mfg. Started :: Revision No: 00
Mfg. Completed : Supersede No: NIL
LABEL CLAIM : Each Soft Gelatin Capsule contains;
SILYMARIN…………………………………140mg
Vitamin A-Palmitate………………………….2500IU
Vitamin B1………………………………….. 1mg
Vitamin B2………………………………….0.5mg
Vitamin D3………………………………… 300IU
Vitamin C…………………………………....15mg
Nicotinamide……………………………….30mg
Excipients …………...………………………………..Q.S
Description: Green colored Oblong shaped soft gelatin Capsule Containing Yellowish brown colored homogeneous
oily Paste.
Die Size: 19 minim (Shape: Oblong, Cavity 24x04)
Packing: 02 Blister x 15 Capsules
Storage: Store in a cool & dry Place, Protect from Light.
NOTE :
 Any change in this Batch Manufacturing & Packing Record requires prior approval of Production
Manager and Q.A Manager.
 Any deviation in the Manufacturing & Packing process requires prior approval of Production
Manager and Q.A Manager jointly & entry in the deviation sheet.
Documentation completion verified by:
QA Executive Production Manager QA Manager

Sign Sign Sign

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 03 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

Packing Material Requisition (For BMR) Date of Issue: _____________

Item Code Items A.R. No. Std Qty Qty Returned Actual Sign Sign
Required Issued Qty Qty Store QA
used
P-200313 Printed Aluminum
Foil (159 mm)
P-10067 Clear Transparent
PVC (163mm)
P-400301 Printed Cartons
(02 x 15 Caps)
P-50020 Local Shipper Box
(460 x 400 x 285)

Packing Supervisor Store In charge

Sign Sign

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 3A of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

Packing Material Requisition (For Store) Date of Issue: _____________

Item Code Items A.R. No. Std Qty Qty Returned Actual Sign Sign
Required Issued Qty Qty Store QA
used
P-200313 Printed Aluminum
Foil (159 mm)
P-10067 Clear Transparent
PVC (163mm)
P-400301 Printed Cartons
(02 x 15 Caps)
P-50020 Local Shipper Box
(460 x 400 x 285)

Packing Supervisor Store In charge

Sign Sign

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 04 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

A. GOOD MANUFACTURING PRACTICES

I. Gowning Requirements:
 Persons of manufacturing area must be gowned.
 While performing any operation, must wear hand gloves and nose mask.
 Do not wear any ornaments while performing any operation.

II.Checking the status of equipment:

 Ensure that all equipments are labeled as "Cleaned", “Ready for use" before start of operation.
 Ensure that line clearance is issued by the supervisor before start of all operation.
 Ensure that line clearance is issued by the QA person before start of all operation in addition to line
clearance
 After completion of any operation affix “To be cleaned “status label and cleaned equipment should
be used within 48 hours of use.
 Ensure that all the measuring devices are in calibrated status at the time of use.

III. Safety Requirements:

 Do not open any machine lid or cover while the machine is operating.
 Lubricate all moving parts before start of operation under required to be lubricated while operation.
 Wear protective equipment like goggles and earplugs.

IV. Controls :
 Collect all issue slips and attach them at the back of page 2 of BMPR.
 The critical manufacturing operation should be performed under controlled environment as
specified in BMPR.
 Any adverse incidence or spillage or deviation observed should be immediately informed to the
superiors.

V. General Instructions :
 Time should be recorded in standard format.
 In case an error in recording any information strikes the wrong entry and record the new entry
with initials.

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 05 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:
B. List of Machinery and Equipments
Sr. Name of Equipment Capacity SOP No. SOP No. Equipment
No. Operation Cleaning ID No.
1 Electronic Balance 100 Gm PR0122 PR0124 BSCPL/PRO/EQP/
150 Kg
2 S.S Manufacturing Tank 500 Kg. X 1 Nos. PR0305 PR0306 BSCPL/PRO/EQP/
3 SS Vessels 100 Lit x 3 Nos. PR0312 PR0313 BSCPL/PRO/EQP/
4 Sieves 80# & 120# PR0324 PR0325 BSCPL/PRO/EQP/
5 Hot Plate 0°C to 200°C PR0326 PR0327 BSCPL/PRO/EQP/
6 Vibratory sifter - PR0331 PR0332 BSCPL/PRO/EQP/
7 Homogenizer - PR0303 PR0304 BSCPL/PRO/EQP/
C. Pre–Manufacturing Control Operations
 Read the BMPR thoroughly before proceeding with operation and follow it strictly.
 Carry out all the activities related to equipment cleaning and material handling strictly as per
respective standard operating procedures.
 Label all the material of process stages.
 Label all equipment and areas with status and product label and display prominently.
 Label all the recoverable and non-recoverable materials clearly and prominently. Dispose the
materials as per standard operating procedure.
 Get Q.A line clearance before beginning of every operation.
 All personnel must observe stipulated gowning code for respective area.
 Protective mask, surgical gloves and any other safety provisions must be followed.
 Check and record room temperature and humidity.
 Any deviation from the BMPR must be done with prior approval of QA on deviation request.
ENVIRONEMNTAL CONTROL
Temperature : __________ °C Date & Time : ___________
% Relative Humidity : _______ % Date & Time : ___________
( Limit : Temperature Below 25°c & Humidity Below 60 % RH )
Production Chemist : __________

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 06 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

LINE CLEARANCE: (IN MEDICINE MANUFACTURING AREA)

Date :______________________
Previous Product : ______________________
Batch No : ______________________
Sr. OPERATION Observation Checked by:
No Prod QA
1 All raw material & Semi finished product of previous YES/NO
product is removed.
2 Area cleaned for any material spillage/product spillage. YES/NO
3 Tools/Tags of previous product are removed. YES/NO
4 Waste bins in the area are emptied & cleaned. YES/NO
5 Equipment required are cleaned:
a. _____________ b.______________
YES/NO
c. _____________ d. ______________

e. _____________ f. ______________

6 Raw materials of products are received from store. YES/NO

7 Proper entries are made in equipment log sheets. YES/NO

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 07 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:
D. Medicine Manufacturing Process:
Date Step Manufacturing Process Done Checked Remark
by by
1.0 Sift all the raw material through Respective sieve.
1.1 Sifting starting time : _______
Sifting completion time : ______
2.0 Filtration :
2.1 Filter Soya bean oil USP _______ kg through #120 Mesh filter.
Filtration starting time:_______
Completion time ________
3.0 Melting :
3.1 Into the melted Soya bean oil add BHA, BHT, and White Bees
Wax.
3.2 Heat till homogeneous oil mass is obtained.

4.0 Mixing :
4.1 Transfer the filtrate of step 2.1 in to S.S. Mfg. Tank; Keep aside
____ Kg Soya bean oil for rinsing. Add the Soya lecithin with
continuous stirring.
4.2 Add the Melted solution from step 3.2 in step 4.1, Start the
homogenization with the homogenizer.
4.3 Keep the homogenize mixture for 30 Minutes. (At the time of
Homogenize the mixture temperature are drop about 40°C)
4.4 Add the Silymarin________ Kg, previously pass through 80 #,
with continuously Stirring.
Add one by one Vitamin A Palmitate ______ Kg, Vitamin
B1_________ Kg, Vitamin B2 _________ Kg,, Vitamin
C__________ Kg, ,Nicotinamide ________ Kg.. with
continuous Stirring.
4.5 Add _______Kg of Soya bean Oil & Vitamin D3__________
Kg with continuous Stirring.
4.6 Mix whole medicine till to get homogeneous paste.
Mixing Starting Time : ________
Mixing Completion Time : _______
4.7 Vacuum Pressure : _________
(Vacuum Pressure Limit : 650 to 700 mm of Hg )
Vacuum starting time : ________
Vacuum completion time : ________
4.8 After completion of Vacuum, weigh the medicine.

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 08 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

 In-Process Sampling:

Quality Control Sampling: (Medicine)

Send Test Request to QC Department for withdrawal of approximately 50 gm of sample for analysis.
Transfer the medicine in Quarantine Area.
Sampling done By: __________ Date and Sign: ____________

After getting QC approval of Medicine ,

 Analytical Report No:-_______________ Date_____________
(For Medicine)

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD

Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 09 of 33

Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

 Medicine Weight:

Tank Gross Tare Net

No. Weight (kg) Weight (kg) Weight (kg)

Total Weight:

E: BATCH RECONCILLIATION

1. Std. Quantity :
2. Sample Quantity :
3. Manufacturing Loss :
4. Quantity after Manufacturing process:
5. % Yield:

Reported by: Checked by: Approved by:

Production Officer: Production manager: QA Manager:
(Sign) (Sign) (Sign)

 Production Chemist/Officer: __________

 After getting QC approval of Gelatin Mass,

 Gelatin Mass:
 Batch No. ______________
 Date of Manufacturing: ____________
 Analytical Report No.: ________________ Date ____________

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD

Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 10 of 33

Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

LINE CLEARANCE: (IN ENCAPSULATION AREA)

.

Date : _____________________
Previous Product : _____________________
Batch No : _____________________
Sr. OPERATION Observation Checked by:
No Prod QA
1 All Encapsules of previous product is removed. YES/NO

2 Area cleaned for any material spillage/product spillage. YES/NO

3 Labels/Tags of previous product are removed. YES/NO

4 Encapsulations filing machine/ Tumbler /hopers are cleaned. YES/NO

5 Pipes for Gelatin Mass and Pipes for medicine are cleaned. YES/NO

6 Waste bins in the area are emptied & cleaned. YES/NO

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD

Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 11 of 33

Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

IN-PROCESS PARAMETERS

Net content per Capsule : 600 mg

Limit of Net content per capsule (600 mg ± 5%)

Follow the following frequency for in-process checks during Encapsulation.

Sr. PARAMETER LIMITS Checking

No. Frequency
In-House Spec. Limit Regulatory limit
01 Net content per Capsule ±5 % ± 7.5% Every 1 hour
02 Room temp. and %RH Below 25C & 60 % RH Below 30C & 65 % RH Every 4 hours

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD

Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 12 of 33

Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

F. ENCAPSULATION MACHINE SPECIFICATION & OBSERVATION:

Note: Before the start the Encapsulation machines check the following parameters, all the parameter of
machine comply and then start the encapsulation.

Machine No : ID No.:
Parameters Limit Observation Done
By
Time Date Time Date Time Date Time Date

Gelatin 51° C to
Temp. 55° C

51 L*
Spreader to R*
Box Temp. 55 L*
°C R*

Segment 37 °C
to 42 °C

0.80 to
Ribbon 0.90
Thickness mm

Speed
(RPM)

Note: All the parameters are check after two hours during the encapsulation. Any deviation found in parameter
during the encapsulation, immediately inform to production in-charge or Production Manager.
L* = Left side Gelatin Mass Temp.
R* = Right side Gelatin Mass Temp.

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD

Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 13 of 33

Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:
G. ENCAPSULATION PROCESS: Gelatin Mass Batch No.: __________________

Date Step Manufacturing Instructions Done Checked Remark

by by
5.0 Machine Setting
5.1 Set Encapsulation Machine No. _______ As per SOP No. :
SOP.PR0505 Machine ID BSCPL/PRO/EQP/____
5.2 Set the Die : 19 minim ( Shape : Oblong, Cavity 24x04 )
6.0 Gelatin Mass Setting
6.1 Set the Gelatin Mass tanks Batch No._________ and set the
temperature of tank.
6.2 Check the temp. of Gelatin Mass ( Left and Right side )
6.3 Check the Ribbon Thickness. If Ribbon Thickness are meet the
specification, then go for further process.
6.4 Check the segment temperature.
7.0 Encapsulation Process
Encapsulation Starting Time _________
7.1 Set the weight with light liquid paraffin. If Weight are set as
per specification limit then transfer the medicine in hopper.
7.2 Destroy the light liquid Paraffin capsule and then transfer the
medicine in hopper.
7.3 Start the encapsulation of medicament. Check the fill weight
of the capsule; if necessary adjust the fill weight.
7.4 Check the shape, sealing of capsule. If Satisfactory of physical
parameter then start the conveyer belt in forward direction.
7.5 Start the tumbler. Pass the capsule into tumbler.
7.6 After passing through tumbler collect the capsule in cleaned
S.S Trays and spread immediately. Keep the tray on Tray rack.
7.7 Transfer the Tray in Capsule dried room / Area.

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD

Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 14 of 33

Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

H. INPROCESS CHECKING RECORD: Shift: _________

No Uniformity of weight Uniformity of weight
Date Time of Capsule Shell Net Checked Date Time Capsule Shell Net Checked
Cap weight weight content by weight weight content by
01
02
03
04
Ribbon Thickness: Ribbon Thickness :
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD

Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 15 of 33

Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

H. INPROCESS CHECKING RECORD: Shift: _________

No Uniformity of weight Uniformity of weight
Date Time of Capsule Shell Net Checked Date Time Capsule Shell Net Checked
Cap weight weight content by weight weight content by
01
02
03
04
Ribbon Thickness: Ribbon Thickness :
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 16 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

H. INPROCESS CHECKING RECORD: Shift: _________

No Uniformity of weight Uniformity of weight
Date Time of Capsule Shell Net Checked Date Time Capsule Shell Net Checked
Cap weight weight content by weight weight content by
01
02
03
04
Ribbon Thickness: Ribbon Thickness :
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 17 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

H. INPROCESS CHECKING RECORD: Shift: _________

No Uniformity of weight Uniformity of weight
Date Time of Capsule Shell Net Checked Date Time Capsule Shell Net Checked
Cap weight weight content by weight weight content by
01
02
03
04
Ribbon Thickness: Ribbon Thickness :
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:
01
02
03
04
Ribbon Thickness: Ribbon Thickness:
Sealing: Sealing:

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 18 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

I. DRYING ROOM / AREA ENVIRONMENT RECORDS:

[Limit: Temp: Below 25°C, RH: Below 25 %]
Date Time Temp % RH Checked Date Time Temp % RH Checked
by by

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 19 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

J. Capsule oil removal and policing procedure:

Ensure the cleanliness of pan Area.
Ensure the cleanliness of Pan and set the machine with 24” Pan.
Speed of Pan: 20- 25 RPM

Date Step Process for oil removing and policing Done Checked Remark
by by
8.0 After completion of 48-72 hours in dried section,
8.1 Load ______ kg of capsules in pan for removal of oil.
Operate the pan machine as per S.O.P No. PR0701, Add
Kintex paper to remove oil.
Pan machine starting time: ________ End time:________
8.2 After completion of pan washing transfer capsules in
cleaned HDPE container.
8.3 Transfer the capsule in an inspection room or send the
capsule for Printing and then inspection room

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 20 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

 In-Process Sampling:

Quality Control Sampling: (Semi-finished)

Send Test Request to QC Department for withdrawal of approximately 60 Capsules of sample for analysis.
Sampling done By: ________ Date and Sign: ____________

After getting QC approval for D.T, & Other In-Process Test,

Capsule Transfer for Inspection or Printing.

Disintegration Time:-_______________ ( NMT 60 Minutes),

Analytical Report No:_______________ Date:-_____________

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 21 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

K. INSPECTION:

LINE CLEARANCE: (IN CAPSULE INSPECTION AREA)

Date : ______________________
Previous Product: _____________________
Batch No: ______________________

QA Checked : ___________

Temperature : __________ & %RH : __________

[ Limit : Below 25  C , Below 60 % RH ]

Sr. OPERATION Observation Checked by:
No Prod QA
1 Previous product is removed. Yes/No
2 Capsule Inspection Area Clean as per S.O.P No PR0901 Yes/No

3 Clean the Inspection belt as per SOP No. PR0904 Yes/No

4 Area cleaned for any material spillage/product spillage. Yes/No

5 All Accessories/Tools/Vessels are cleaned. Yes/No

6 Labels/Tags of previous products are removed. Yes/No

7 Waste bins in the area are emptied and cleaned. Yes/No

8 Proper entries are made in equipment log sheets. Yes/No

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 22 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

L. CAPSULE INSPECTION PROCESS:

Date Step Process for capsule Inspection/Sorting Done Checked Remark
by by
9.0 Check the Inspection Machine as per SOP No. PR0902
9.1 Start the machine as per S.O.P No. PR0903
9.2 Follow the instruction given in SOP No. PR0903 for
operation of Inspection machine.
9.3 Inspected/sorted capsules are packed in poly bags and
weigh the capsules.
9.4 After completion of Capsule Inspection, clean the
machine as per sop No. PR0904

WEIGHT OF INSPECTED CAPSULES.

A) Theoretical batch Size = ______________ Caps.

B) Weight of good capsules =_____________ Kg =_____________ Caps
C) Rejected Capsules for destruction = ______________Kg =____________Caps

B X 100
% Yield = ___________ = %
A

* Store the rejected and discarded capsule in an isolated container with proper identification.

Quantity of Rejected Capsules : (Approximately) ________________ Caps

Rejection Destroyed as per S.O.P. No. PR0908

Rejection Destroyed by : Checked by QA :

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 23 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

M. CAPSULES TRANSFERRED TO PACKING DEPARTMENT

Physically Random check the printed / Check Point :

Inspected Capsules by Q.A.Officer and give
the Release for Blister / Packing.
 Check the Randomly, capsule printing are satisfactory
 Capsules are properly cleaned and proper hardness.
 Capsules Sorting / Inspection are done, if any defect
found on capsule give reinspection.
 Labeling on Bag is proper.

Release given by QA Chemist/Officer: _____________

Date : ___________

Quantity of Bulk Capsule transferred to Packing Department ____________ Kg.

Quantity Transferred by : _______________ Received by : _____________

Production Chemist Packing Supervisor

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 24 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

DEVIATION REPORT

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 25 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

Packing Material

Packing Material Requisition (For Packing) Date of Issue: _____________

Item Code Items A.R. No. Std Qty Qty Returned Actual Sign Sign
Required Issued Qty Qty PKG QA
used
P-200313 Printed Aluminum
Foil (159 mm)
P-10067 Clear Transparent
PVC (163mm)
P-400301 Printed Cartons
(02 x 15 Caps)
P-50020 Local Shipper Box
(460 x 400 x 285)

Packing Supervisor
Sign

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 26 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

LINE CLEARANCE: (IN PACKING AREA.)

Department: primary & secondary packing Blister Pack Machine ID No.______________

Packing Line No: ___________
Date:__________
Previous Product: ______________________
Batch No: ______________

Sr. OPERATION Observation Checked by:

No Prod QA
1 Foils of previous products are removed. Yes/No
2 Packed/Unpacked blister are removed. Yes/No
3 Machine labels and activity labels are removed and correct labels Yes/No
are affixed.
4 Waste bins are emptied. Yes/No
5 Stereo of previous product are destroyed/removed. Yes/No
6 Primary packing materials are received from store. Yes/No
7 Packaging material is visible cleaned. Yes/No
8 Ensure the Humidity Below 60 %. Yes/No
9 Labels of previous products are removed. Yes/No
10 Destroy/Remove Cartons/Leaflet of previous product Yes/No
11 Packaging slips, secondary packaging material of previous Yes/No
product are removed.
12 Finished goods of previous product are removed. Yes/No
13 Printed packing material is received with issue slip. Yes/No
14 Printed packaging material are checked by supervisor and cleared Yes/No
for use.
15 Overprinting correctness of first sample is approved by Yes/No
department

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 27 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:
N. LIST OF EQUIPMENT AND MACHINERY
Sr. NAME OF THE ID No. SOP NO. SOP NO.
No. MACHINE OPERATION CLEANING
1 BLISTER PACKING MACHINE BSCPL/PRO/EQP/_____ PR1006 PR1007
2 LEAK TEST APPARATUS BSCPL/PRO/EQP/_____ PR1012 PR1013

Sr Parameter ALUMINIUM
No. FOIL
01 Batch No
02 Mfg. Date
03 Exp. Date
04 M.R.P.
05 Printed By
06 Checked By
07 Approved By

BLISTER PACK:

a) Set Blister pack machine for as per SOP No. : SOP.PR1006

b) Check packing goods for proper packing
c) Identify the capsules
d) Blister the capsules with the aid of blister machine using printed blister foil and clear
blister PVC 163 mm as per approved specification in a blister cut of 15capsules per
blister.
e) Pack 02 such goods / checked blister of 15 capsules in a Printed carton. As per statutory
requirements.

 KEEP THE TEMP. OF THE SEALING ROLLER BETWEEN ________° TO ________° C

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 28 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

Packing style:

 15 Capsules in Blister Pack. (Printed Aluminum Blister foils 159 mm and Clear PVC of 163 mm)
 02 Blister Strips pack in printed Carton. (02 x 15 Caps)
 ______ Cartons pack in one 7 ply corrugated boxes and seal with Plain BOPP Tape and shrink
with plain Clear Tape.

O. IN-PROCESS PACKING RECORD

Date Time Done By Checked

Blister Counting Cartoning Final By
Inspection Packing

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 29 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

P. INPROCESS CHECKING RECORD

Date Time Coding Blister Inspection Quantity in Checked

Carton By
( )

 LEAK TEST FOR BLISTERS:

PERFORM LEAK TEST OF THE BLISTER PACK BY TAKING _______ BLISTERS AT A TIME AS PER S.O.P. NO PR1012 AT
EVERY TWO HOUR OR AT THE TIME OF CHANGE OF ALU. FOIL OR PVC WHICHEVER IS EARLIER.
ALSO WHENEVER M/C RESTARTED AFTER DISCONTINUATION, RECORD THE SAME:
Date Start Time End Time No. of Blisters % Fails Remarks Sign

After starting of Packing send samples to QC department for finish product analysis.
Sample drawn by QA sign:-____________ Quantity- 600 Capsules.
Approvals: Prepared by: Checked by: Approved by:
Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 30 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:
FINISHING FORM

 CHECK THE CLEANLINESS OF THE AREA, MACHINE AND THE CONVEYER BELT

YES / NO SIGN ____________

 THERE SHOULD NOT BE ANY UNWANTED MATERIAL AND REMAININGS OF PREVIOUS

BATCH OR PRODUCT IN THE AREA. YES / NO SIGN ____________

 CHECK IDENTITY AND THE QUANTITY OF PRODUCT TO BE PACKED.

YES / NO SIGN ____________

 MACHINE STARTED DATE : _________________ TIME : ____________SIGN ____________

 PACKING STARTED DATE : _________________ TIME : ____________SIGN ____________

 CODED ALU. FOIL SAMPLE ATTACHED. YES / NO SIGN ____________

 REFERENCE CARTON AND LABEL ESTABLISHED. YES / NO SIGN ___________

 FIRST PACK CHECKED BY __________ DATE : _________ TIME ___________

 FINAL COMPLETE PACKAGE CHECKED BY _________ DATE _____ TIME ____________

 DATE COMPLETED : _________________ TIME : _______________ SIGN ____________

 QUANTITY FINISHED PACK : _______________

STEREO DESTRUCTION RECORD:

Date of Quantity Quantity Quantity Destroyed Checked

Destruction Received Used Destroyed By By (QA)

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 31 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

ATTACH SPECIMEN OFALUMINUM FOIL, CARTON AND SHIPPER LABEL TO THIS SHEET:

Packing Supervisor :

Date :

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 32 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

Q. PRINTED PACKING MATERIAL RECONCILIATION:

Printed Packing Plain Carton Printed Blister Clear PVC Destruction

Material Foil Blister Foil Done In
Presence of QA
Qty.
Required (A)
Qty.
Issued (B)
Qty.
Used (C)
Quantity Online Rej.
Destroyed (D) Coded
Uncoded
TOTAL
Qty. Returned
(E)
Total
Consumption
(F)
C+D

Acceptance criteria: For carton ± 1.0%

Quantity packed :____________________

Retain sample Quantity :___________________
QC Report No:-________________ Date:-_______________
Quantity Transferred to Finished Goods Warehouse Date :_____________
Goods transfer slip attach to the BMPR________

Packing Supervisor ________________

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date
 BRIYOSIS
Soft Caps Pvt. Ltd., Jarod, Dist.: Vadodara
BATCH MANUFACTURING AND PACKING RECORD
Product Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Page No. 33 of 33
Generic Name : SILYMARIN +VITAMIN B COMPLEX CAPSULES Batch No.:
Mfg. Date : Exp. Date : Batch Size:

R. BATCH RECONCILLIATION RECORD:

1. THEORETICAL BATCH SIZE:__________________ CAPSULES

2. SAMPLES FOR ANALYSIS

2.1 MEDICINE FOR BULK ANALYSIS: __________ GM = __________CAPSUELS

2.2 QUANTITY OF INPROCESS SAMPLE: _________________ CAPSULES

2.3CAPSULES FOR FINISHED PRODUCT ANALYSIS = ___________CAPSULES

2.4 RETAIN SAMPLES: _____________ CAPSULESS

2.5 STABILITY SAMPLES: ____________ CAPSULES

3.0 QUANTITY TRANSFERED TO FINISHED GOODS

WAREHOUSE: _______________CAPSULES

4.0 TOTAL QUANTITY DESTROYED___________ KG = _______________ CAPSULES

5.0 PERCENTAGE YIELD

(2 + 3)
--------------- x 100 = ________ % ( LIMITS : NLT 96.00% )
(1)

NOTE: IF YIELD IS LESS THAN 96.00%, PLEASE INVESTIGATE.

Completed batch manufacturing record checked by:

Production Officer: Packing In-charge:

Production Manager: QA Manager:

Approvals: Prepared by: Checked by: Approved by:

Department QA Officer Production Manager QA Manager

Signature

Date