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Packaging – Checklist

No.
Question
Options
1
Are all the Packaging Lines have sufficient distance from each other to prevent mix-ups?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
2
Is the facility has a Master Packaging Procedure in place and well documented?
Yes
No
N/A
3
Are all Packing Operations follows the Master Packaging Procedure, to perform the process and correctly use all the equipment?
Yes
No
N/A
4
Are all operations documented on the Batch Packaging Record?
Yes
No
N/A
5
Is every Packaging Line distinguished and labeled with specific Product Name, Batch Number, and Packaging size?
Yes
<10% not ok
>=10% not ok
No
N/A
6
Is at any given time on a Packaging line only one Product, Batch, and Packaging size processed?
Yes
No
N/A
7
Are Product Identity, Quantity, Batch Number, and Status labeled and marked on each Bulk products, Partly-packed Product, or Sub-batch products?
Yes
<10% not ok
>=10% not ok
No
N/A
8
Are all Products after filling into their final containers, and before going for the labeling and final packaging, segregated based on Product Identification, Batch Number, and Status?
Yes
<10% not ok
>=10% not ok
No
N/A
9.a
Is a Documented Process available to ensure that the correct, printed, and unprinted packaging components used for packaging?
Yes
No
N/A
9.b
If Yes, are the Staff following the process?
Yes
<10% not ok
>=10% not ok
No
N/A
10.a
Is a Documented Process available for, how to receive, and identify Bulk and Packaging components?
Yes
No
N/A
10.b
If Yes, are the Staff following the process?
Yes
<10% not ok
>=10% not ok
No
N/A
11.a
Is a Documented Process available for how to reconcile Bulk products and Printed packaging materials?
Yes
No
N/A
11.b
If Yes, are the Staff following the process?
Yes
<10% not ok
>=10% not ok
No
N/A
12.a
Is a Documented Process available for how to do the final package examination?
Yes
No
N/A
12.b
If Yes, are the Staff following the process?
Yes
<10% not ok
>=10% not ok
No
N/A
13
Is a Separate Area available to filling and packaging of Toxic Products or Sensitizing Agents?
Yes
No
N/A
14
Is every Packing immediately follows the Filling and Sealing process?
Yes
No
N/A
15
Does the Last Package of the production of each operation thoroughly checked to match with the specifications?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
16
In the Pallet, are only Finished Products from the packaging operation placed?
Yes
No
N/A
17
Are all Finished Products properly Quarantine until they get confirmation of the final release from the QC team?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
18
Does the quantity indicated for Party-filled Carton/Container?
Yes
No
N/A
19
Does checking done that after each packaging operation, all excess Packaging Components, remaining Bulk Products, and rejected Packaging Components removes from the working site and packaging lines?
Yes
No
N/A
20
After checked by the Supervisor, only the identified Packaging materials and Bulk products are returned to Warehouse?
Yes
No
N/A
21
Does the supervisor calculated and recorded the quantities of Packaging Materials and Bulk Products used in each packaging operation?
Yes
No
N/A
22.a
Is a documented process of In-process Sample Check available, which describes, how to select the point of Sampling, frequency of Sampling, number of Samples to be checked, etc.?
Yes
No
N/A
22.b
If Yes, are the Staff following the process in the time of the In-process Control check?
Yes
<10% not ok
>=10% not ok
No
N/A
23.a
Is a documented process of In-process Specifications Check available which describes, what are the specification needs to check, and what are the limits of acceptance for each specification, etc.?
Yes
No
N/A
23.b
If Yes, are the Staff following the process in the time of the In-process Control check?
Yes
<10% not ok
>=10% not ok
No
N/A
24
Are all Products(from receiving to packaging) checked throughout the run at regular intervals for their full compliance with specifications?
Yes
No
N/A
25
Do Batch Identification numbers checked throughout the packing operation for all products?
Yes
No
N/A
26
Are all Results of the In-Process Check, recorded, and included in the Batch Packaging Record?
Yes
No
N/A
27
Are Entry Restricted to the Packaging area?
Yes
No
N/A
28
Is the checking done to ensure no person is bringing any Drugs/Medicines in the Packaging area?
Yes
No
N/A
29
Does the Packaging area has an adequate number of Staff?
Yes
No
N/A
30
Does the Packaging Area under proper supervision?
Yes
No
N/A
31
Are all the staff of the Packaging area got the required and updated Training, which includes GMP(Good Manufacturing Practice) training?
Yes
<10% not ok
>=10% not ok
No
N/A
32
Are all the Personnel present at the Packaging area wearing Protective Clothing and Equipment(Uniforms, Gloves, Mask, etc.)?
Yes
No
N/A
33
Are adequate Light Fittings, Pipeworks, Ventilations, and other Services available and functional in the packaging area?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
34
Are the required Humidity, Temperature, Filtration, etc. maintained and recorded for the area?
Yes
No
N/A
35
Are there Equipment available and functional to regulate the required Humidity, Temperature, Filtration, etc.?
Yes
No
N/A
36
Are all the Data for Regulation well documented?
Yes
No
N/A