SOLITAIRE PHARMACIA PVT. LTD.

1.  Objective

To define the procedure for carrying out In-Process Checks and Controls during manufacturing and packing of Tablets.

2.  Scope

This SOP is applicable to all manufacturing Products at Solitaire Pharmacia Pvt. Ltd., Baddi

3.  Responsibility

QA department

4.  Accountability

Head Q.A

5.  Procedure

5.1.  In-Process checks and controls during Manufacturing :
5.1.1.  QA shall check the Batch Manufacturing Record of the batch being processed at every stage for.
Ø  Online entries.
Ø  Correctness of entries.
Ø  Legibility of entries.
Ø  Compliance with standard procedures, specifications and regulatory requirements.
5.1.2  During the process, if any deviations / Out of Specification are observed, the activity shall be stopped and deviation/ Out of Specification shall be raised as per SOP No.
SPL/SOP/QA/010 or SPL/SOP/QA/037
5.1.3  The Environmental conditions related to temperature and humidity shall be monitored at regular intervals at the place where environmental conditions and records are to be maintained and the records maintained as per SOP no.SPL/SOP/QA/011
5.1.4  Operational status of the manufacturing line shall be checked on the entry door.
5.1.5  Cleaning status of the area & equipment shall be checked as per SOP no. SPL/SOP/PR/009 & SPL/SOP/PR/004
5.2.  In-Process Checks For Tablets
5.2.1  Environmental control
Ø  Check humidity and temperature.
5.2.2  Materials
Ø  Check the raw materials name, lot number and weight.
Ø  Check the balances and scales use for weighing of materials and calibration status.
5.2.3  Sifting
Ø  Check the equipment cleanliness and Status.
Ø  Check for respective screen use for sifter and its integrity.
5.2.4  Mixing
Ø  Check the equipment cleaning and label status before starting mixing.
Ø  Check the added ingredients, mixing time.
Ø  Check the binder temperature, rate and addition time.
Ø  Check the wet mixing time, speed of mixer.
5.2.5  Drying
Ø  Check label as “Status Label” of an equipment (FBD) and filter bag.
Ø  Check the separate filter bag for each product.
Ø  Check the inlet and outlet air temperature & volume of FBD.
Ø  Check the sifter sieve number to control the oversize granules.
5.2.6  Milling and Sifting
Ø  Check the equipment cleaning and label status before starting mixing.
Ø  Check for respective screen use for sifter and Multimill.
Ø  Check the integrity of screen
5.2.7  Blending
Ø  Check “Status label” of equipment.
Ø  Check lubrication time and mixing time.
Ø  Check that the granules are stored in proper container with label.
5.2.8  Compression
5.2.8.1  Check the compression machine cleaning with label “Status Label”, “Previous run” and date.
5.2.8.2  Check the identification of proper machine to the product, strength, lot number.
5.2.8.3  Check the shop floor label, tablet diameter, thickness, weight, hardness, disintegration time, friability, weight variation, colour, odour, general appearance of tablets, flow of granules and speed of machine
5.2.8.4  For coated tablets, check the edges of the tablets and inner core.
5.2.8.5  Check the processing problems like sticking, capping, lamination, mottling etc.
5.2.8.6  Given below is a list of checks that QA shall check at the beginning and at the frequency mentioned below during compression :
a.  Appearance and tests mentioned in the individual BMR
b.  Average weight
c.  Weight variation
d.  Friability
e.  Hardness
f.  Thickness
g.  DT
h.  Relative humidity
5.2.8.7  If any discrepancies are observed, it shall be immediately communicated to the production personnel for rectification.
5.2.8.8  All in-process checks shall be entered in the respective batch record or reports as per formats attached with this sop.
5.3.  In Process Controls For Packing Line
5.3.1  The QA chemist shall check the Batch Packing Record of the batch being processed at every stage for:
Ø  Online Entries
Ø  Correctness of Entries
Ø  Legibility of Entries
Ø  Compliance with Standard Procedures and Regulatory Requirements
Ø  Types of Packing:
Ø  Strip Packing
Ø  Blister Packing
Ø  ALU ALU Packing
5.3.2  Check the name of product, Mfg. Date, Exp. Date and Batch No. of the Packing Line product.
5.3.3  QA shall check the item code of the printed packing material and also the over printing details.
5.3.4  Carry out the following in-process checks at the start, middle and end of the operation and record the observations in the Batch Packing Record.
Ø  Overprinting detail on Aluminum foil
Ø  Overprinting detail on carton
Ø  Carton Fill value
Ø  Overprinting detail on shipper
Ø  Shipper Fill Value
Ø  Sealing roller temperature and leak test.
Ø  Check the sealing roller temperature if machine is idle for more than 30 minutes. Record the observations.
Ø  Check the leak test at the start of the activity middle of the activity and at the end of activity. Record the observations.
5.3.5  Check for standard weight and standard packing.
5.3.6  Check the counting and weighing during packing operation.
5.3.7  If any discrepancy is observed, it shall be immediately communicated to the packing personnel for rectification.
5.3.8  All in-process checks shall be entered in the respective batch packing record.
6.  Records/Formats
SPL/QA/083 - In-process Report Bulk
SPL/QA/084 - In-process Report Tablets
SPL/QA/085 - In-process Report Packing

7.  Annexure

NA

8.  Reference:

Nil

9.  Abbreviations:

SOP - Standard Operating Procedure

QA - Quality Assurance

NA - Not Applicable

10.  Revision History:

Revision No. / Effective Date / Reason for Revision
00 / New Document

Format No.SPL/QA/001

SOLITAIRE PHARMACIA PVT. LTD.

In-process Report Bulk

Format No. SPL/QA/083

Product Name______Batch Size______Batch No.______

MFG.______EXP.______Date______

S.N / Date /Time / After Drying Initial / After Adjustment /final drying ( Limit NMT______%) / Done By / Checked By
LOT-1 / LOT-2 / LOT-3 / LOT-1 / LOT-2 / LOT-3

In-process Report Tablets

Format No. SPL/QA/084

Date______

Product Name Batch Size Batch No. MFG EXP.

% LOD______Assay of Bulk______

S.No. / Test / Standard / Result
1.  / Punch specification
2.  / Description
3.  / Individual weight of 20 Tablets / + 5%
4.  / Group weight for 20 tablets / + 2 %
5.  / Disintegration time / NMT 10min
6.  / Thickness / ± 0.2mm
7.  / Length / ± 0.2mm
8.  / Width / ± 0.2mm
9.  / Diameter / ± 0.2mm
10.  / Hardness / NLT Kg./ cm2
11.  / Friability / NMT 1% w/w
12.  / Individual weight 20 Coated Tablets / + 5%
13.  / Coated Tablet DT / NMT 15min
14.  / Leak Test / OK/Not OK

Checked By (IPQA) Approved by QA

Note : In case of Tests do not comply the product requirement, stop the operation and inform to QA Head & MFG chemist for rectification.

In-process Report Packing

Format No. SPL/QA/085

Product Name______Batch Size______Batch No.______

MFG.______EXP.______Date______

MRP______

Frequency ® Start + Every 1 hours

Date & Time / Sealing Roller Temp.
_____ -_____ °C / Correctness / Overprinting / Leak test OK /
Not OK / Done By
ALU Foil / PVC/ALU

Checked by: ………………

(Sign & date)

Format No.SPL/QA/001