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Thursday, January 5, 2012

SOP OF SOP









SOP of SOP (SOP on SOP) in Pharmaceuticals








SOP of SOP (SOP on SOP) in Pharmaceuticals


1.0              OBJECTIVE


To
lay down a procedure for the preparation, approval, authorization, control and
revision of Standard Operating Procedures.


 


2.0              SCOPE


This
SOP describes the basic principles, defines the responsibilities and lays down
the procedure for preparing SOPs. This SOP shall be applicable to all the SOPs
at ................


3.0              RESPONSIBILITY


3.1       Preparation &
Execution: Executive and above


3.2       Approval: Asst. Manager
and above


3.3       Authorization: Asst.
General Manager and above


 


4.0              ACCOUNTABILITY


Head
of the Concerned Department


 


5.0              PROCEDURE


 


 


5.1              Prepare the SOP on the approved
format on A-4 size paper.


 


5.2              Prepare the SOPs to
describe the operating procedures and steps.


 


5.3              Write all the SOPs in
clear, unambiguous language, easy to understand and easy to follow.


 


5.4              Write the SOPs under the
following sub-headings:


 


 


1.0          OBJECTIVE


2.0          SCOPE


3.0          RESPONSIBILITY


4.0          ACCOUNTABILITY


5.0          PROCEDURE


6.0          REFERENCES


7.0          ANNEXURES


8.0          ABBREVIATIONS






 


 


5.4.1                    OBJECTIVE


Write here the reason for preparing the SOP in one sentence or
maximum two sentences starting with a letter
 ‘To’.


 


5.4.2                    SCOPE


This Section defines the applicability of the SOP and also
specifies departments, areas or sections to which this SOP shall be applicable.


 


5.4.3                    RESPONSIBILITY


Write here the designation of the person / persons who are
directly responsible for the operations mentioned in the
 ‘Objective’ of the SOP.


 


5.4.4                    ACCOUNTABILITY


Write here the Head of the Department who is accountable for
compliance of the SOP.


 


5.4.5                    PROCEDURE


     
5.4.5.1   Write the procedure/method in short sentences. Do not write
the instructions in long paragraphs.


 


5.4.5.2   
 Mention all the checks to be carried out, records to be maintained,
frequency of various operations, checks and special precautions, if any.


5.4.5.4       Enclose all the
Annexures with SOP if applicable.


 


5.4.6                    REFERENCES


Mention
a list of references or any other guidance documents based on which the SOP has
been prepared. If there is no reference for the SOP, mention ‘Not Applicable’
under this subheading.


 


5.4.7                    ANNEXURES


                 
Mention a list of all Annexures enclosed in the SOP. If there is no Annexure in
the SOP, mention ‘Not Applicable’ under this subheading.


 


 


5.4.8        ABBREVIATIONS :


Mention
a list of all abbreviations & their full forms/descriptions used in the
SOP. If there is no Abbreviation in the SOP, mention ‘Not Applicable’ under
this subheading.


 


 


5.5                 Write the SOP in English
(If required, some of the SOPs shall be written in local language i.e Hindi).


 


5.6                 FORMAT
REQUIREMENTS :


Prepare all the SOPs as per specimen format given as Annexure I
to this SOP.


The
type of font for the contents in SOPs shall be  ‘Times New Roman’
 .The font size to be used
for contents of SOPs shall be as follows:


 


5.6.1           FONTS


 


 



Content of SOP


Size of Font


Header


“STANDARD
OPERATING PROCEDURE” & “TITLE”


12
Bold in Upper Case


Torrent
Logo on the right hand corner


30
mm (L) x 6 mm(H)


“TORRENT”
( on top left corner )


14
Bold in Upper Case


“Pharmaceutical
Ltd.” “Restricted Circulation” “Location”, “Dept.”, “Area”, “Page”, “SOP
No.”, “Revision No.” “Effective Date”, “Supersedes”, “Review Date”,
“Initiated By”, “Approved By”, “Authorized By”, “Name”, “Signature &
Date”


10
Bold in Title Case


Actual
Title ( detailed heading ) of SOP


12
Bold in Upper Case


Body


Subheadings


12 Bold in Upper Case


Write up of SOP


12 in Sentence Case


Footer


“Format No.”


10 in Title Case


Actual format number


10 in Upper Case


 


5.7              NUMBERING
SYSTEM OF  SOP


 


5.7.1      Each SOP
shall have a unique numbering system. Once number is allocated to any SOP, the
same   number shall not be repeated to other SOP.


 


5.7.2      Each SOP
No. consists of seven alphanumerical characters. For example first SOP prepared
in the QA department shall be numbered as BQA-001.


5.7.2.1  
1st
 alpha character indicates the location code where ‘B’ indicates
for Baddi.


5.7.2.2      2nd alpha character indicates department code and 3rd alpha character indicates subsection/area code  for the
departments mentioned in the point no. 5.7.3.


5.7.2.3      For departments other
than point no. 5.7.3,  2nd   & 3rd
 alpha characters indicate department code as mentioned in the
point no. 5.7.4.


5.7.2.4      4th character is dash’-‘ for separator.


5.7.2.5      5th ,6th & 7th numerical characters
indicate serial number of that particular department code. ‘001’ indicates
first SOP prepared under particular department code.


 


5.7.3            Department wise Code for
SOP Numbering system for Manufacturing and Quality Control:


 



Department


Department Code


General


Operational & Calibration


Cleaning


Code for SOP No.


Beta
Lactam


Mfg. & Packing


B


G


O


C


BG/BO/BC


Non
Beta Lactam


Capsules


C


G


O


C


CG/CO/CC


Liquid Orals


L


G


O


C


LG/LO/LC


Packing


P


G


O


C


PG/PO/PC


Quality Control


Q


G


O


C


QG/QO/QC


Tablets


T


G


O


C


TG/TO/TC


Other
Departments


Engineering


E


G


O


C


EG/EO/EC


Safety,
Health & Environment


S


G


O


C


SG/SO/SC


Ware
House

(
RM, PM, FG Quarantine )


W


G


O


C


WG/WO/WC


 


5.7.4              Department wise Code for
SOP Numbering system for other departments:


 



Department


Code for SOP No.


Accounts


AC


Administration


AD


Human
Resources & Development


HR


Information
Technology


IT


Production
Planning & Supply Chain


PP


Purchase


PU


Quality
Assurance


QA


 


5.7.5              For example, the first
General SOP of Tablet department shall be numbered as BTG-001.


 


  
5.8        CONTENTS OF HEADER


  


5.8.1              Location : The name of location of the plant  for which SOP is
applicable.


5.8.2              Department : The name of the Department for which SOP is applicable.


5.8.3              Area: The area / sub-section of the Department shall be mentioned
wherever applicable.


5.8.4              Title: Detailed heading of the SOP.


5.8.5              SOP No.: Unique SOP No. as per procedures described in the point no. 5.7
shall be mentioned here.


5.8.6              Revision No. :  Revision No. consists of two numerical characters which
start from ‘00’ with increment in one digit after each revision. ‘00’ indicates
the first issuance of that particular SOP.


5.8.7              Effective Date: The effective date shall be stamped by Q.A. after final
authorization before circulating the SOPs.


5.8.8              Supersedes: For the first issuance, ‘New introduction’ shall be mentioned in
this column, otherwise  effective date of obsolete ( previous) SOP shall
be mentioned.


5.8.9              Review Date: The normal review period will be 2 years from the effective date
of the SOP. For example if any SOP is having effective date “07-10-2004”, its
review date will be “07-10-2006”. Revision of SOPs shall be done as per
procedure mentioned in the point no. 5.13.


5.8.10          Page : The  page number shall be mentioned in ‘xx of yy’ format.


5.8.11          Signatures : The Header comprises of three columns i.e. Initiated By,
Approved By & Authorized by.


              
Each of the three columns consist of 3 rows i.e. Name of the person who signs
the SOP in full signature and the date on which the person signs the SOP.


5.8.11.1    Initiated by : Designated person, who has initiated  the SOP shall
write  name clearly  with  signature &  date in blue
ink in the column “Initiated By”. 


5.8.11.2    Approved by: Two persons shall approve the SOP after review. One of them
shall be concerned Department Head and the other shall be Head of Quality
Assurance. They shall write name clearly with signature and date in blue ink.
In case of QA SOPs first approval shall be done by Asst. Manager and above and
second approval shall be done by the Manager and above of the  Quality
Assurance Department.


5.8.11.3    Authorized by: The person finally authorizing the SOP, shall sign here.
Authorization shall be done by Location Head, who shall write name clearly with
signature and date in blue ink. In case of QA SOPs, the Location QA Head shall
authorize all the SOPs except the SOP No. BQA-001 (Preparation, Approval,
Authorization, Control and Revision of SOPs). This SOP shall be authorized by
Vice President – Corporate QA.


 


5.9     
   CONTENTS OF FOOTER


 


5.9.1       Format No.: This is a unique number assigned to the format used for
preparation of all SOPs as described in the point no. 5.11.4.


 


5.10                GENERATION OF NEW
SOPs


 


5.10.1          User dept. shall prepare
the draft SOP as per the procedure described in the point no.5.4 to 5.9. Draft
copy shall be identified by stamping or water mark on each page.


 


5.10.2          Draft copy shall be
circulated to the responsible persons for its review. The responsible persons
may recommend  for any changes in the text.


 


5.10.3          Based on the
recommendation, user dept. shall correct the draft SOP and take final print out
for approval and authorization along with Change History Log.


 


5.10.4          After approval and
authorization, user dept. shall submit the Original Copy ( Master Copy ) of SOP
along with ‘Change History Log’ to QA for control and issuance and shall
destroy the draft SOP.


 





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