1.0.
OBJECTIVE:
Procedure
for reviewing the documents.
2.0.
SCOPE:
This Procedure is applicable for reviewing all completed
BMR, BPR, MCF ,
MCP, Specifications, Protocol and Report of Validation, Qualification,
analytical reports, Deviations and OOS report at Company.
3.0.
RESPONSIBILITY:
3.1.
Manufacturing is
responsible for reviewing the completed BMR, BPR, MCF ,
MCP.
3.2.
QC personnel are
responsible for reviewing the analytical reports, OOS report.
3.3.
QA personnel are
responsible for reviewing change control, deviation, validation reports and
protocol and also verifying all reviewed data.
4.0.
PROCEDURE:
4.1.
Manufacturing Executive
shall review the BMR and Packaging officer shall review the BPR.
4.2.
Analytical reports
shall be reviewed by QC personnel.
4.3.
Follow Annex-I entirely
during the review of the batch records.
4.4.
QA personnel shall
verify the weighing sheet, Batch reconciliation, and yield against the
specification.
4.5.
QA shall verify the
release status of all the material used for manufacturing and packaging.
4.6.
Any deviation or OOS
shall be completed before preparing the COA.
4.7.
Once the review is
completed, the batch shall be released to the commerce after issuing the COA.
5.0.
ANNEXURE:
Annex-I
: Document Review sheet
6.0.
REFERENCES:
Nil
7.0.
ABBREVIATION:
|
Sr. No.
|
Abbreviation used
|
Full form of abbreviation used
|
|
1.
|
QA
|
Quality Assurance
|
|
3.
|
QC
|
Quality control
|
|
4.
|
OOS
|
Out of specification
|
|
5.
|
COA
|
Certificate of Analysis
|
|
6.
|
BMR
|
Batch Manufacturing Record
|
|
7.
|
BPR
|
Batch Packing Record
|
|
8.
|
MCF
|
Master card Formulation
|
|
9.
|
MCP
|
Master card Packing
|
8.0.
DISTRIBUTED TO:
Quality assurance, Manufacturing , Quality
control.
9.0.
REVISION HISTORY:
|
Revision
|
Change
Control Number
|
Reason
for the Modifications
|
|
|
|
|
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