(SOP on SOP) Procedure for preparation, control, distribution, review, revision and retrieval of standard operating procedures. (SOP on SOP)

1.0.            OBJECTIVE:

To lay down a procedure for preparation, control, distribution, review, revision and retrieval of Standard operating procedures

2.0.            SCOPE:

This SOP shall be an applicable for all the departments of Company- plant for preparing their standard operating procedures.

3.0.            RESPONSIBILITY:

3.1.            Officer / Executive / In-charge of all each departments.

3.2.            QA Head for approval and compliance of the SOP

4.0.         PROCEDURE:

4.1.            Preparation of SOP

4.1.1.        All the SOPs are to be generated by computer in the format known as "Standard Operating Procedure" “(Refer Annexure -V).

4.1.2.      The page setting parameters for the designing as below.

Parameters	Size
Paper Size	A4
Top Margins	0.50”
Bottom Margins	0.50”
Left Margins	0.50”
Right Margins	0.50”
Line	1.5mm
Alignment	Justify
Gutter	0.00”
Header from edge	0.60
Footer from edge	0.60”

4.1.3.        The text of SOP conforms to the following guidelines.

Parameters	Location	Size
Language	English	Times New Roman
Translation language (if applicable)	Regional language	Times New Roman
Logo of Company	Header	Height- 0.48”, width -1.00”
Company	Header	Times New Roman, 12pt., Bold, Capital
Standard Operating Procedure	Header	Times New Roman, 12pt., Bold, Capital
Other text	Header & Footer	Times New Roman, 12pt., Normal
Body text	Body	Times New Roman, 12pt., Heading capital, Normal
Format number	Footer	Times New Roman, 12pt., Normal
Instructions / information’s	-	Times New Roman, 12pt., Bold, Capital
Printing colour	-	Black

4.1.4        Department: Type name of the department as per refer Annexure -III

4.1.5        All specific instructions requiring more attention are given with a bullet

4.1.6        All specific instructions requiring more attention are given with a bullet and the instruction is printed in to bold Times New Roman.

4.2              SOP Number: This is a unique number given to each SOP. This number consists of  fourteen characters as described below

4.2.1        SOP Number (No.): SOP numbering shall be in the following manner:

SOP number as SOP-XXX-YYY-ZZ.

Where XXX stands for department code as per annexure-III 

YYY stands for SOP serial number which starts with 001 for each individual department.

ZZ stands for revision number of SOP which starts with 02.

While revising SOPs with old numbering system:

4.2.1.1  ZZ (that is revision number) will be added up to that in old SOP. For example, Old SOP number is SOP-QAD-001-01 (where 01 is revision number), new SOP number will be SOP-QAD-001-02.

4.2.1.2  YYY (that is serial number of SOP) will be the immediate number in series that will be available for the NEW SOP i.e. 001,002,003…..

4.2.1.3  If two or more than two SOPs are merged in that case revised SOP Number will be the number of first SOP.

            EXAMPLE: To assign SOP number follow as under:

Total number of digits	14
First, Second & Third Digit	SOP
Fourth Digit	Hyphen  ( - )
Fifth, Sixth & Seventh  Digit	Department Code
Eighth Digit	Hyphen  ( - )
Ninth, Tenth & Eleventh Digit	SOP serial number
Twelth Digit	Hyphen  ( - )
Thirteenth & Fourteenth Digit	Revision/ revision number of SOP

4.2.2        Page No.: The Page numbers of an SOP must be assigned in the form A of  B,

4.2.3        Where A is the number of that page and B is the total number of pages of the SOP where annexure shall not be the part of page numbering of that SOP.

4.2.4        Effective Date: This date is the date on which SOP is going to be effective. It shall be stamped with blue ink by QA officer / Executive.

4.2.5        QA after training of that SOP the Effective Date must be given in form of DD/MM/YY.

4.2.6        Review Period: SOPs need to be reviewed periodically in order to ensure that the SOP is relevant with respect to operations carried out and to include any change in operation noticed during the review. It shall be two years after the effective date. SOP can be reviewed early, if the respective operation covered under the SOP demands. The review date must be given in form of DD/MM/YY.

4.2.7        Supersede No.: Here, previous SOP number is to be mentioned when that SOP is changed or reviewed and new revision number is allocated. e.g. if SOP-QAD-001-01 is revised, new SOP number is allocated as SOP-QAD-001-02 and then Supersede no. shall be SOP-QAD-001-01. If two SOPs are merged then write SOP number of both SOPs as Supersede No.

4.2.8        Prepared By: Person (Officer) who performs or who is going to supervise or both shall write the SOP after it is clear how the task shall be performed. This person shall prepare the SOP and once it is finalized, person shall write person name and date in blue ink. Date must be written in the form of DD/MM/YY. The name of the person and designation shall be in hand written in capital latter.

4.2.9        Checked By: Concern department head must review the SOP and put his/her signature, write person name and date in blue ink.  Date must be written in the form of DD/MM/YY. The name of the person and designation shall be hand written with capital letters.

4.2.10    Approved By: Quality Assurance Head must approve the SOP and put person signature, write his/her name and date in blue ink. Date must be written in the form of DD/MM/YY. The name of the person and designation shall be hand written with capital letters.

4.2.11    Footer will remain same for the all pages of SOP and Annexure-V

4.3              Mostly the content of the SOP must be divided into following sub headings.        

4.3.1        OBJECTIVE

4.3.2        SCOPE

4.3.3        RESPONSIBILITY

4.3.4        PROCEDURE

4.3.5        ANNEXURE

4.3.6        REFERENCES

4.3.7        ABBREVIATIONS

4.3.8        DISTRIBUTED TO

4.3.9        REVISION OF HISTORY

4.3.10    OBJECTIVE: The reason for writing the SOP shall be mentioned here. Normally it must be one or two sentence statement. It must normally start with word ‘To’.

4.3.11    SCOPE: This SOP shall be applicable for all the departments of Company, plant for preparing their standard operating procedures.

4.3.12    RESPONSIBILITY: State the person responsible for performing the described activity and responsible for the compliance of the SOP.

4.3.13    Write the stepwise instructions with caution and note to be followed for carrying out an activity.

4.3.14    PROCEDURE: Write the stepwise instructions with caution and note to be followed for carrying out an activity. Use simple language. Use short sentence. Any document required to record information such as form, format, checklist etc shall be attach to the SOP as an Annexure; such annexure (s) shall be numbered as per the numbering SOP.

4.3.15    ANNEXURE: Prepare supporting documents of SOP or recording formats of SOP as Annexure of the SOP. Annexure shall not be the part of page numbering of that SOP. The company logo and location shall be appear on left hand top corner of each page of annexure. The annexure of any SOP content the first row is company location Company, , and page number at the right side of page, i.e. if annexure of 2 pages then pages shall be numbered as page 1 of 2 and 2 of 2.  Text mater of annexure is Standard Operating procedure, Department, area, SOP number and subject. SOP number shall be along with revision number of that SOP. The format number shall be appear at the bottom left side of each page, Refer Annexure-V for the format of Annexure. All annexures shall be stamped as “MASTER COPY” in red ink at top right corner.

4.3.16    REFERENCES: Here, reference of authentic document shall be referred on the basis of which SOP has been prepared. Mention all references used in the SOP.

4.3.17    ABBREVIATIONS: List out all the abbreviations used in the SOP and elaborate them.

4.3.18    DISTRIBUTED TO: Mention the names of the departments where the SOP is to be distributed.

4.3.19    REVISION HISTORY: Brief Revision History of changes shall be written with revision number, change control number and reason for change.

4.4              PROCEDURE FOR FORMAT NUMBERING SYSTEM:

4.4.1        Numbering system shall include appropriate formats, product labels etc., needed to record the compliance of the SOP.

4.4.2        Each format shall be given a number. The number consists of 14 characters.

4.4.3        The first, second, third characters stands for department code as mentioned in Annexure-III.

4.4.4        The Fourth character stands for “-”(Hyphen)

4.4.5        The fifth, sixth, seventh character stands for serial number of the SOP.

4.4.6        The Eighth character stands for “-”(Hyphen)

4.4.7        The ninth character stands for “F”as a format.

4.4.8        The tenth, eleventh characters stands for serial number of the format for that particular SOP.

4.4.9         The Twelth  character stands for “-”(Hyphen)

4.4.10    The thirteenth, fourteenth characters stands for revision number of respective format.

4.4.11    Example: QAD-001-F01-01 is the first format, made first time and related to first SOP of QA department and if it is revised first shall be numbered as QAD-001-F01-02. The first time any Annexure is prepared, revision no. shall be numbered ‘01’.The next revision shall be ‘02’ and so on.

4.4.12    Format No. shall appear on left side of bottom in footer of the SOP.

4.4.13    If any flow chart, informative contents etc.having more than one page the format number remain same in all pages.

4.4.14    If SOP is revised and no changes done in format or annexure, all the formats and annexure shall be approved with the revised SOP as it is.

4.5              PREPARATION AND APPROVAL:

4.5.1        User department in which the activity starts shall originate as a draft SOP.

4.5.2        The draft SOP shall be prepared in the prescribed format as per Annexure-V.

4.5.3        Draft SOP shall be reviewed by the head of the department for technical adequacy and accuracy. Head of the department in which the SOP originates shall ensure that the SOP is accurate, adequate and acceptable to all the concerned departments.

4.5.4        Draft SOP shall be reviewed by head of QA department/ designated QA personnel for compliance with the user departments. (QC, Manufacturing (Tablet, Capsule), Warehouse, Engineering, HR, department etc.).

4.5.5        Any correction or review comment shall be discussed, resolved and corrected between the user department(s) mentioned and QA. At the end of this stage the SOP draft is deemed approved.

4.5.6        Once SOP is approved is, user department shall conduct training on respective SOP in coordination with the training coordinator.

4.5.7        The effective date for implementation of new SOP or revised SOP shall be mentioned manually blue ink color stamp on the SOP only after training.

4.5.8        The photocopy of the training records of the new SOP’s / revised SOP’s shall be attached to the Master SOP.

4.5.9        The soft copy of the approved draft SOP shall be transferred to the computer of QA, after the final printout is taken, which will be under control of Document Control.

4.5.10    The responsibility of deletion of soft copy from the computers of other departments lies with Document Control & the department heads.

4.5.11    The SOP approval shall be as follows:

4.5.11.1                      Prepared by: Department personnel who prepared the SOP.

4.5.11.2                      Checked by: incharge of department (s) to which SOP belongs/    

                         incharge relevant department where the SOP is affected.                                      

4.5.11.3                      Sign after ensuring that the SOP is accurate, adequate and         acceptable to all departments and annexure mentioned in SOP are accurate.

4.5.11.4                      Approved by: Head QA/ Designee Sign after ensuring the SOP is checked and signed by In Charge of the department to which the SOP is assigned.    

4.5.11.5                      The draft copy shall be destroyed after final SOP is made effective.  

4.6              Review of SOP:

4.6.1        Every SOP shall be reviewed once in every 2 years by the concerned personnel and head of the department. Time period +15 working days.

4.6.2        During review or otherwise any changes desired and deemed necessary shall be initiated through a “Change Control”. For change control procedure follows SOP No. SOP-QAD-002-02.

4.6.3        Whenever SOP is reviewed, the changes made shall be entered in the revision history of the respective SOP.

4.6.4        In case there are no changes required for the existing SOP during review period, procedure to be followed as per SOP “Preparation, Distribution, Control and Review of Documents”.

4.6.5        During the revision of SOP, if there is no change in the annexure then the                 revision no. of the annexure shall remain the same as previous. Such SOP shall be stamped with “REVIEWED ON” near the master stamp and reissued as per SOP for “Preparation, Distribution, Control and Review of Documents”(Annexure-I)

4.6.6        The above stamping shall be in blue ink and signed by head-QA or designee with date. Such stamping is valid up to one time only.

4.7              Issue and Control:

4.7.1         Original copies of SOP’s shall be stamped as “MASTER COPY” (Annexure-VIII) in red color ink at top right side of each page.

4.7.2        Control and Distribution SOPs shall be controlled and Distributed as per procedure mentioned below.

4.7.3        For preparation of control copies for distribution, the photocopies of the master copies shall be taken and shall be stamped as ‘Controlled Copy’ (Annexure-VIII)  in green ink at bottom right side of each page.

4.7.4        The copy number shall be corresponding to the department code to which the controlled copy is being issued as per SOP annexure-III for department codes. First control copy shall be issued each department and second copy shall be issue as display copy. 

4.7.5        The record of issuance, retrieval and destruction of different documents shall be maintained on form ‘Document Distribution, Retrieval & Destruction Record’ (Annexure-I).

4.7.6        The controlled copy of the respective master document shall be distributed to the concerned department (s) and the initials of the distributing QA personnel and receiving respective departmental personnel shall be taken on form ‘Document Distribution, Retrieval & Destruction Record’ (Annexure-I).Issue the new revision only after the retrieval of the issued control copy of the previous revision.

4.7.7        Destroy the retrieved control copies of the document and enter the necessary details in the destruction record (Annexure-I).

4.7.8        Each page of old master document shall be stamped as “OBSOLUTE” in red color ink and the controlled copies shall be destroyed. The “OBSOLUTE” stamp shall be put at center of each page and transfer to” OBSOLUTE DOCUMENTS” file.

4.7.9        For operational use, the annexure attached with the SOPs as formats (for recording) shall be photocopy from the issued controlled copy to user department, however additional photocopying of Controlled copies of the master documents is not allowed.

4.7.10    In case any additional copy of the “MASTER COPY” is require by department for further usage, a request for additional issuance shall be raised to QA department with proper justification and approval from Head of the department on form “Request for Additional Issuance of Documents” (Annexure-II.)

4.7.11    The QA person shall prepare the additional photocopy for preparation, issuance and distribution as per 4.5 to 4.5.11.5 and 4.7.to 4.7.10.

4.7.12    In case the additional copy is being required for any external agency / any department for reference purpose, the same shall be issued by photocopying and each page shall be stamped as “UNCONTROLLED COPY” in black color ink at bottom of the center of each page (Annexure-VIII). In such cases the record of distribution shall not be maintained.

4.7.13    Respective department Head will keep a track of the documents due for review.

4.7.14    All SOP’s shall be reviewed over a period of two years or whenever change is required.

4.7.15    The QA person shall put a blue ink stamp of “REVIEWED ON” near The “MASTER COPY” stamp at top right side of each page (Annexure-VIII) on “MASTER COPY” of the document in red color and shall put initial and the same shall be “Reviewed On” and for further 2 years.

4.7.16    The above stamping shall be in blue ink and signed by Head-QA or designee with date. Such stamping is valid up to one time only.

4.7.17    Blue ink pen shall be used for sign, date, name and designation.

4.7.18    SOP shall be made effective within 90 days after the date of approval.

4.7.19    Department head shall prepare and update the SOP index as per SOP No.SOP-QAD-56-01 .Annexure VII based on the SOP issued to them by QA.

4.7.20    Master SOP index shall be prepared by QA department and the same shall be updated on Quarterly basis.

5.0              ABBREVIATION    :  

Sr. No.	Abbreviation used	Full form of abbreviation used
1	SOP	Standard Operating Procedure
2	QA	Quality Assurance
3	QAD	Quality Assurance Department
4	QC	Quality Control
5	HR	Human resource
6	No.	Number
7	c-GMP	Current Good Manufacturing Practice
8	Sign	Signature

6.0              ATTACHMENTS (ANNEXURE) :

                        Annexure-I      : Document Distribution, Retrieval & Destruction Record

Annexure-II    : Request For Additional Issuance Of Document

Annexure-III   : List Of Departmental Codes And Copy Numbers.

                        Annexure-IV   : Request For Extension Of Review Period

Annexure-V    : SOP format

Annexure-VI   : Flow Chart for Preparation, Approval, Distribution Control and Revision                                                   of SOP

                        Annexure-VII : SOP Index

                        Annexure-VIII            : Specimen of Seals

            7.0       DISTRIBUTED TO: All departments.

8.0      Revision History :

Revision Number

Change Control No

Reason for the Modifications