Follow
Objective: To lay down the procedure for Preparation, Approval, Authorization, Control and Revision of Standard Operating Procedure (SOP).
Scope: This SOP is applicable for all departments of (Company Name).
Responsibility All Department Heads for Preparation and Implementation.
Accountability : Plant Head / Quality Assurance Head.
Precautions: The concerned department personnel who have sufficient knowledge about operation procedure and current GMP shall prepare SOP.
Procedure
1 All SOP’s shall be as per the Approved Format given in Annexure- I.
2 ‘Standard Operating Procedure’ shall be typed on letter size (8.5 x 11 inches) white paper marked diagonally at the center with blue coloured “CONFIDENTIAL” and a blue band of width 11 mm, at the bottom bearing text” Copies marked with this blue band are the master document(s)”with below mentioned standard page format.
Left margin : 1.0” Top margin : 0.5”
Right margin : 0.5” Bottom margin : 0.5”
Letter type : Times new roman
Letter size of SOP No., Page No., Eff. Date, review date & Dept.: 12 Capital.
Letter size of Text: 12 Letter size of word ‘ Title’: 12, Bold.
Letter size of subheadings: 12, Bold, Footer : 12, Capital.
Letter size of SOP Title: 12, All Capital letters. Company Address: 10, Capital Bold.
Standard Operating Procedure word: 12, Capital Bold.
Company Name: 14, Bold, All Capital letters on top of each page at the Center.
Company Logo: Standard uniform size on top of each page at left hand side.
Space of line between two different points: One “enter” space of 1.0 line spacing.
Space of line after subheading: One “enter” space of 1.0 line spacing.
Space of line between points and subheading: space of 1.5 line spacing.
Each pages an external frame in single line.
All points in the SOP should be numbered sequentially and the sub paragraphs of the SOP should also be numbered sequentially with an incremental number derived from the needing number.
e.g. If the needing number is 5.0 the first sub paragraph shall have a number as 5.1 and the next incremental rise as 5.2, 5.3…………., and if there is paragraph within it shall be numbered as 5.1.1 and the next incremental rise as 5.1.2, 5.1.3…………………..
3 However for Annexure, the font size can be reduced to accommodate all the contents in one row.
4 SOP shall be written in a clear, unambiguous, easy to understand and in user-friendly English language.
5 Short sentences shall be used with all checks to be done, frequency of various operations/activities, records to be maintained.
6 Definition (s) / Abbreviation (s) wherever necessary shall be explained.
7 Prescribed Formats/Checklists/Flowcharts wherever necessary shall be incorporated as Annexure (s), which shall be serially, numbered starting with ‘I’ (Romanic One). Each page shall be serially numbered separately.
8 All the SOPs shall be written with the following sub-headings.
i. OBJECTIVE
ii. SCOPE
iii. RESPONSIBILITY
iv. ACCOUNTABILITY
v. PRECAUTIONS
vi. PROCEDURE
vii. REFERENCES
viii. REVISION HISTORY
Above sub-heading(s) shall contain the following details –
Objective: The purpose of writing the SOP shall be clearly mentioned here in brief.
Scope: This part shall describe the areas including equipment/make/model etc. as applicable.
Responsibility: The designation of the person (s) who are directly responsible for the implementation /operation of the SOP shall be mentioned here.
Accountability: The designation of the person (s) either immediate superiors of the persons mentioned under “Responsibility” or the Departmental Head depending on the purpose of SOP shall be mentioned here.
Precautions: A list of precaution(s) appropriate to the relevant SOP to be mentioned.
Procedure: Procedures pertaining to the objective of the SOP shall be described in detail, with clear, unambiguous and user friendly English language.
Refferance: References shall be mentioned wherever applicable.
Revision History: Revision of SOP shall be done as and when necessary to incorporate changes as per current regulatory requirements and on expiry of review date. Such changes shall be given in the Revision History with proper reason for review.
9 PROCEDURE FOR FILLING SOP FORMAT (Refer Annexure -I)
9.1 The format of SOP contains 9 items. Each item in the mentioned form is briefly explained below.
Item 1: DEPT – Name of the department originating the SOP shall be mentioned here.
Item 2: SOP No. – This shall be a unique number given to each SOP consisting of eight characters broken down as follows –
( – – ) (- – -) ( – ) ( – – )
Dept. Code SOP No. Dash Revision No.
The first two characters are the letters of Alphabet denoting the originating dept. The code for each dept. is given below:
Department Code
Production (General) PG
Production (Manufacturing) PM
Production (Packing) PP
Quality Assurance QA
Quality Control QC
Research & Development RD
Department Code
Warehouse WH
Human Resources HR
Engineering EG
Planning PL
Purchase PU
Information services IT
Regulatory RG
Training TR
Environment, Health & Safety ES
Note: – In case of an addition in the list of department the concerned Department Head and Quality Assurance Manager shall finalize the abbreviation. The Next three characters denote SOP No. & Sixth characters shall be “-” (Dash).
The last two digits denote the “Revision No.” In case of a new SOP this number shall be ’00’. The next revision would be ’01’ and so on.
For Example, 9th SOP of QA Dept. having Revision No. 02 shall have SOP No. as QA009-02.
Item 3: PAGE NO. – It shall bear the running page number followed by the total number of pages on the format of ‘X OF Y’.
Item 4: EFF. DATE – It shall be the date when SOP is scheduled to be effective and shall be in the format of DD/MM/YYYY.
Item 5: REVIEW DATE – Review date shall be 02 years from the effective date of the SOP. All the SOPs shall be reviewed maximum after 02 years. However in case of any change, as and when the change is implemented the SOP shall be reviewed and reissued. Review date shall be the date after 02 years when SOP is scheduled to be effective and shall be in the format of DD/MM/YYYY.
Item 6: TITLE – It shall describe the title of the SOP. The title shall be relevant with the SOP. The title of the SOP for the equipment operation and cleaning shall have the respective equipment ID.
Item 7: PREPARED BY – Name, designation and sign of the person who has prepared the SOP with date in Blue ink.
Item 8: CHECKED BY – Name, designation and sign of the concerned department/ section Head who has checked the SOP and approved the content of SOP with date in Blue ink.
Item 9: AUTHORISED BY – Name, designation and sign of the Head of QA or his/her Nominee who has authorized the SOP with date in Blue ink.
6.10 MASTER COPY: Marked diagonally at the center with light blue coloured “CONFIDENTIAL” and a blue band at the bottom bearing text “Copies marked with this blue band are the master document(s)”.
11 DISTRIBUTION OF SOP
11.1 The SOPs shall be distributed to all those departments, whose activity/Operation(s) / Practice(s) and /or Record(s) may be affected by the implementation of the said SOP.
11.2 Sufficient time is given between issue date and effective date to enable training of concerned people. All the employees will be trained on the relevant SOPs. After training on SOPs, the trainees shall declare in written (From No. FTR/006 of SOP TR001) that they have read the SOP & understood the requirements in the SOPs and can apply the training knowledge in their work place.
11.3 After preparation of master copy, QA person shall take out the required number of photocopies and shall stamp in the right side bottom of all pages with Red Ink bearing following details.
• Serial No. of Copy
• Date of Issuance
• Sign of QA Person
11.4 The stamped and numbered copies as above shall be termed as “OPERATIONAL
COPY”.
11.5 If an additional copy of SOP is required by any department for non-operational use then QA dept. shall issue an additional copy only after written approval from QA Manager. Such requests shall be obtained through the Request Form as per Annexure -II and shall be forwarded through the department head.
All photocopied SOP’s shall be stamped with blue ink on all the pages as “UNCONTROLLED COPY” across the text and shall be signed by the QA Manager under the stamp.
11.6 If an additional copy of the SOP is required for operational use by any department other than those mentioned in the distribution list, then the photocopy of the Master copy of the SOP shall be stamped, numbered and issued to the concerned department as per the procedure followed for the issuance of the Operational Copy.
12 The SOP shall be distributed to all concerned departments and the distribution record shall be maintained by Quality Assurance Department as per Annexure -III (SOP Control Register).
13 The Master Copy of the superseded SOP shall be maintained in the QA department stamped as “OBSOLETE FOR REFERENCE ONLY” in Blue Ink.
14 All Operational Copies of superseded SOPs shall be retrieved from the respective departments, when revised version becomes effective. All such copies shall be reconciled and destroyed. The Record shall be maintained in the SOP Control Register.
