Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-033.00 Effective date: mm/dd/yyyy
Approved by:
52.4
Procedure
52.4.1 SoP
S
f
ormat
All SOPs will have the fixed format on each page (as above) apart from page 1 where the header of
the SOP will be having additional space beside the “effective date” and “review date” to stamp the
date when the particular SOP is becoming effective after the completion of SOP training evaluation
and SOP validity date due for the next review, respectively.
52.4.2 S
uBject
In the space for “subject,” write the heading of the SOP, for example, “Housekeeping of the plant.”
52.4.3 SoP n
o
.
All SOPs will be abbreviated according to the ABC Pharmaceutical Company numbers and depart-
ment using the following alphabetical codes. Each abbreviation will be assigned a numerical number
in an increasing order.
example
soP code
department
number
QAS
Quality assurance system
001
ENS
Engineering system
001
Therefore, the number assigned to the SOP will be QAS-001 and/or ENS-001.
52.4.4 w
ritten
By
Preferably written by the systems follower and machine operator as required.
52.4.5 c
hecked
By
All SOPs shall be checked by the departmental managers.
52.4.6 a
PProved
By
All SOPs shall be approved by the QA managers or authorized by the technical manager.
52.4.7 r
eviSion
n
o
.
In the space for “Revision No.,” write the number, for example, 1 if the SOP is revised for the first
time. If the SOP is written for the first time, do not assign any number. Instead write 00 in the space.
52.4.8 B
aSed
on
In the space for “Based on,” write down the reference (e.g., CFR, WHO, or PICs) or preferably the
current practice. It is the responsibility of the QA manager to identify and prepare a list of SOPs
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