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1.0
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PURPOSE
To lay down the procedure to be followed for release
of a batch of the product.
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2.0
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SCOPE
This procedure is
applicable to all products at Company Name.
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3.0
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RESPONSIBILITY
Officer/Executive - QA is responsible for the Batch
Release.
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4.0
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ACCOUNTABILITY
Head Quality Assurance
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5.0
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PROCEDURE
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5.1
5.1.1
5.2
5.2.1
5.2.2
5.2.3
5.2.4
5.2.5
5.2.6
5.2.7
5.2.8
5.2.9
5.2.10
5.2.11
5.2.12
5.2.13
5.2.14
5.2.15
5.2.16
5.2.17
5.2.18
5.2.19
5.3
5.3.1
5.3.2
5.3.3
5.3.4
5.4
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.4.7
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BATCH RECORD AUDIT:
Head Quality
Assurance / Executive Quality Assurance shall review and check the following
records for their correctness and compliance:
BATCH PROCESSING RECORD.
Issue of Batch
Processing record by Quality Assurance with signature and date .
Batch
Processing records issued are appropriate and in accordance with the current
and approved Master copy of Batch Processing record.
Each
significant step in the manufacturing, processing is accomplished including
dates and identity of major equipment’s meet.
Specific
identification of each Material of the batch.
Components
used during the processing or manufacturing are weighed correctly and
weighing operation shall be carried out in presence of QA person.
In process Quality Control checks and results.
Process
control checks and results.
Calculations
of yields at appropriate phases of manufacturing or processing and the
percentage of theoretical yield and limits established and indicated in BPR.
The Quality
Assurance person as indicated in Batch Processing Records as witnesses in each
critical step in the manufacturing and processing.
Inspection of the packing and labeling area
before use & line clearance by QA.
Actual yield
and percentage of theoretical yield at appropriate phases of operations as
indicated in batch packing records.
Reconciliation
records.
Specimens of
all packing components used in packing and signed by packaging supervisor and
Quality Assurance persons.
Description of
product containers and closures used with their identification.
Signature of
persons performing and supervising or checking each significant step in the
operation.
If any
Deviation done in the process, it shall be documented and investigated.
After auditing
the Batch Processing Records, analytical records, and in process samples,
Head Quality Assurance or his designated nominee shall release / reject the
batch and sign with date on the batch records.
Investigation
record shall be prepared if any unexplained discrepancies or the failure of a
batch or any of its components to meet any of the specification with
conclusion and follow up.
It shall be
ensured that appropriate control samples of Final Product, shall be retained
as per SOP of control samples.
BATCH ANALYTICAL RECORDS:
Batch
Analytical Records shall be randomly reviewed for the following:
Certificates
of analysis with remarks / opinion of Analyst and signature of analyst and Head
Quality Control.
It shall be
verified that a cross-reference to environmental monitoring data is
available.
Batch Processing
Records shall be compiled batch wise. The flow chart of batch release shown
as per annexure I.
Part Batch Release:
Part release
for export products shall be considered only under following conditions:
Export order
quantity is less than the standard batch quantity and no further export order
is currently pending for that product.
Dispatch of
packed quantity under one export order gets delayed because of unavailability
of packing material for balance quantity of another export order for the same
batch.
When quantity
for sale is packed and the rest quantity to be packed as Physician Sample
(PS) is likely to take time.
Part release
for Domestic products can be given only under following condition:
When sale
quantity is packed and rest quantity to be packed as Physician Sample (PS) is
likely to take time.
When part of
the batch is packed as physician sample and the rest quantity to be packed as
sales pack cannot be packed immediately due to unavailability of packing
material.
Final batch
release note shall be prepared after final review of COA & batch records
after completion of packing.
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6.0
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REFERENCES
NIL
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7.0
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ANNEXURES
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Annexure No.
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Title of Annexure
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Format No.
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Annexure I
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FLOW CHART OF BPR MOVEMENT
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QA/026/F01-00
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8.0
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ABBREVIATIONS
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Abbreviations
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Full Forms
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SOP
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Standard Operating
Procedure
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QA
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Quality Assurance
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BPR
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Batch Processing Record
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COA
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Certificate of Analysis
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9.0
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DISTRIBUTION
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Master Copy
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Head Quality Assurance
Department
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Controlled office Copy No. 1
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Head Quality Assurance Deptt.
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Controlled office Copy No. 2
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Head Production (Tablet) Deptt.
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Controlled office Copy No. 3
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Head Production (Liquid)
Deptt
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Controlled office Copy No. 4
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Head Production (External)
Deptt
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Controlled office Copy No. 5
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Head Production (Soap)
Deptt
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10.0
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REVISION
HISTORY
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S.No.
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Revision No.
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Effective
Date
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Reason for
Revision
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Details of
Change
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Authorized
By
(sign
& Date)
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Annexure I
FLOW CHART OF BPR MOVEMENT
FUNCTION
RESPOSIBILITY
REQUISITION FOR BMR/BPR PRODUCTION
DEPT.
ISSUE OF BPR QUALITY
ASSURANCE DEPT.
RECEIPT OF BMR/BPR AND INDENT PRODUCTION DEPT
FOR DISPENSING
SUBMIT THE COMPLETED BPR IN ALL PRODUCTION DEPT.
RESPECT DULLY SIGNED AND DATED IN ALL
RELEVANT COLUMNS ALONG WITH COA TO
QA FOR RECORD AND REFERENCE. NO
INCOMPLETE OR
PARTIALLY PACKED
BPR BE SUBMITTED TO QA.
QA SHALL REVIEW, RELAESE
BATCH &
MAINTAIN AND UNKEEP
THE RECORDS, QUALITY ASSURANCE DEPT.TRACEBLE
FOR REFERENCE.
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