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.

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.
5.4.5.3 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

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 alphanumeric characters. For example first SOP prepared in the QA department shall be numbered as XQA-001.

5.7.2.1  1^st alpha character indicates the location code where ‘X’ indicates plant location.

5.7.2.2  2^nd alpha character indicates department code and 3^rd 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, 2^nd & 3^rd alpha characters indicate department code as mentioned in the point no. 5.7.4.

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

5.7.2.5  5^th, 6^th & 7^th 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 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 “01-12-2013”, its review date will be “01-12-2015”. 
5.8.9.1  SOPs shall be revised on need basis with proper justification. All SOPs shall be mandatory reviewed and revised once in two years.
5.8.9.2  Upon first revision of an SOP, the details of revision shall be recorded on the revision page of the respective SOP.

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. 5.7.4. For example: Formats of QA shall have the format no. FQA-001.

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 watermark 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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