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SOP of SOP (SOP on SOP) in Pharmaceuticals


Learn how to write an effective standard operating procedure (SOP) for Pharmaceutical and what should be the content of a Pharma SOP.

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.

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 in India, French in France, English in England & USA).

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
 Logo on the right hand corner
30 mm (L) x 6 mm(H)
“COMPANY NAME” ( 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 XQA-001.
5.7.2.1  1st alpha character indicates the location code where ‘X’ indicates plant location.
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
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 XTG-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 “01-12-2012”, its review date will be “01-12-2014”. 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. XQA-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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