BATCH PACKAGING RECORDS FOR STERILE WATER FOR INJECTION....

1. BATCH PACKAGING
RECORD FOR STERILE
WATER FOR INJECTION
1
Presented By :
RITIKA U. GAJRE.
Roll no : 14
M.Pharm (Q.A.) 2nd Shift
Guided by :
Nikita patel

2. CONTENTS
Documentation
 Purpose of documentation
 Types of Documentation
 Packaging Instruction
 What is batch packaging record….?
 Components
of batch packaging record
format for sterile water for injection

2

3. DOCUMENTATION
The document is information and its supporting
medium , which could be in paper form , c.d ,
computer files , or microfilm.
 Good documentation consists an essential part of
quality assurance system.
 Clearly written documentation prevents errors from
spoken communication and permits tracing of batch
history.
 Specification,
Manufacturing
formulae
and
instruction, procedures and records must be free
from errors and available in written.

3

4. PURPOSE OF DOCUMENTATION
o
o
o
To define the specifications and procedures
for all materials and methods of manufacture
and control.
To ensure that all personnel concerned with
manufacturing know what to do and when to
do it.
To ensure that authorized persons have all the
information necessary to decided whether or
not to release a batch of a drug for sale.
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5. 
To ensure the existence of documented evidence ,
traceability and to provide records and an audit trail
that will permit investigation

And to ensure the availability of the data needed for
validation , review and statistical analysis.
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6. TYPES OF DOCUMENTATION

Guideline :To provide recommended practices and
instruction.

Policy :It is document to establish the
organization interpretation and attitude toward the
regulatory body.
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7. 
Standard operating procedure ( sop) :To provide detailed instructions on
how to implement a process or perform a specific
activity.

Records :It is a document stating results
achieved or providing evidence of activities performed.
7

8. 
Form sand templates :Are a prestructured document with blank
spaces designed for insertion of required information.

Manual :To provide inform action on how a system
or equipment operate.
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9. PACKAGING INSTRUCTION

There should be formally approved packaging
instructions for each product pack size and type.
These should normally include, or make reference to
the following:

(1) The name of the product.

(2) A description of its pharmaceutical form, strength,
and method of application where applicable.

(3) The pack size expressed in terms of the number,
weight, or volume of the product in the final
container.
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10. 
(4) A complete list of all the packaging materials
required for a standard batch size, including quantities,
sizes, and types, with the code or reference number
relating to the specifications for each packaging
material.

(5) Where appropriate, an example or reproduction of
the relevant printed packaging materials and
specimens, indicating where the batch number and
expiry date of the product have been marked.

(6) Careful examination of the packaging area and
equipment in order to ascertain the line clearance
before operations begin
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11. 
(7) A description of the packaging operation,
including any significant subsidiary operations, and
equipment to be used

(8) Details of in-process controls with instructions for
sampling and acceptance limits.
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12. BATCH PACKGING RECORDS
consists :
 Packing work order.
 Over printing details
 Packing details
 In-process checks
 Over printing
 Bottle washing and filling (liquid orals)
 Bottle cleaning and filling (Dry Syrup)
 Packing
 Shipper weight profile
 Deviation record (if any)
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13. BATCH PACKGING RECORDS

A batch packaging record should be kept for each batch or
part batch processed. It should be based on the relevant
parts of the packaging instructions.

The following information should be recorded at the time
each action is taken and, after completion, the date and the
person responsible should be clearly identified by
signature or electronic password:
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14. 
(a) The name of the product, the batch number, and the
quantity of bulk product to be packed, as well as the
batch number and the planned quantity of finished
product that will be obtained, the quantity actually
obtained, and the reconciliation.

(b) The date(s) and time(s) of the packaging operations.

(c) The name of the responsible person carrying out the
packaging operation.

(d) The initials of the operators of the different
significance.
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15. 
(e) The checks made for identity and conformity with the
packaging instructions including the results of in-process
controls.

(f) Details of the packaging operations carried out, including
references to equipment and the packaging lines used, and,
when necessary, the instructions for keeping the product
unpacked or a record of returning product that has not
been packaged to the storage area.

(g) Whenever possible, samples of the printed packaging
materials used, including specimens bearing the batch
number, expiry date, and any additional overprinting. 15

16. 
(h) Notes on any special problems, including details of any
deviation from the packaging instructions, with written
authorization by an appropriate person.

(I) The quantities and reference number or identification of
all printed packaging materials and bulk product issued,
used, destroyed, or returned to stock and the quantities of
product obtained to permit an adequate reconciliation.
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17. STERILE WATER FOR INJECTION

It is a sterile, bacteria-free, solutefree preparation of distilled water for
injection.

It is used as a sterile solvent or
diluent vehicle for drugs or solutions
suitable
for
intravenous
or
intramuscular administration.

In this application, it provides water
for hydration and the drug delivery to
the patient.

The pharmacist typically introduces
these additives and relabels the
container for patient application.
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18. COMPONENTS OF BATCH PACKAGING
RECORD FOR STERILE WATER FOR
INJECTION
 Name
of the product
 Batch
no.
 Formulation
 Date
& time
code no. & pack no.
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19.  Packaging

operation
( A )line clearance
 In-process checks
 Initial
of packing
check
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20. BPR OF PARENTRALS
PACKAGING DESCRIPTION : ____________________
PRECODING OF LABELS AND PRINTED PACKAGING
MATERIALS
EXAMINED AND VARIFIED BY : _____________
(Attach specimen)
NO. OF PRECODED : _______________
LABELS RECEIVED : ___________
PRINTED PACKAGING MATERIAL RECEIVED : ______________
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21. DATE
START
TIME
CLOSE
TIME
NAME OF PERSON RESPONSIBLE
FOR
PACKAGING
OTHER
OPERATION
PACKAGING CHEKING PACKED
VIALS
COUNTING & FILLING
CARTONS
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22. 


TOTAL QUANTITY PACKED : ___________
DATE OF COMPLETION : ___________
QUANTITY COLLECTED AS SAMPLES BY QC DEPARTMENT : ____________
SIGN OF PRODUCTION
DEPARTMENT
SIGN OF QA
DEPARTMENT
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23. PACKAGING OPERATION
A. LINE CLERANCE
Packing line no
Previous product
Batch no
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24. sr.no
Activity
1.
Removed
checked
Done by
Checked
by
Labeled vials,
delabelled
vials, cartons,
Insert
,
wrappers of
the previous
product/b.no
on the table
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25. 2 Labels ,cartoons ,inserts of previous
product near the labeling machine
3 Waste from dustbin's
4 Rejected vials ,labels ,cartons ,inserts of
previous product,/b.no for destruction
5 Stamps removed of previous product /b.no
6 Packed
shippers shifted of previous
product/b.no to BSR
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26. REFERENCES
1) Annurex 3 WHO good manufacturing practices
for
Pharmaceutical products : main principles , WHO
Technical report series no.961 ,2011 pg.no133 ,135
2)http://www.authorstream.com/Presentation/ch
etu30-1217989-bpr/
3)http://www.authorstream.com/Presentation/K
unalvanparia-1649012-batch-packagingrecord/
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