Standard Operating Procedure for Preparation, Review, Approval, Rivision, Issue and control of Standard Operating Procedure (SOP)

1.0 Purpose: To describe procedure to be followed for Preparation, Review, Approval, Revision, Issue and Control of Standard Operating Procedures (SOPs).

2.0 Scope: This procedure is applicable to all Standard Operating Procedures (SOPs) in 'XXX' company.

3.0 Responsibility:

Representative of Respective Department :
•Preparation, revision / periodic review of SOP.

Respective Department Head / designee :
•To review and provide training of SOP.

Representative of Quality Assurance :
•To ensure the implementation and compliance of this SOP.
•To control master copies of SOPs.
•To maintain SOP distribution, archival, retrieval and destruction of SOP.

QA Head :
•To review and approve SOP.
•To ensure compliance of this SOP.

4.0 Procedure:
Brief Description of SOP:

4.1.1 SOP term is used for the abbreviation of Standard Operating Procedure.

4.1.2 SOPs are the step wise procedure which is followed for the performance of various GMP / GLP activities carried out at plant.

4.1.3 SOPs shall be identified and developed for all key operations in the plant.

4.1.4 All SOPs shall be prepared on the approved format.

4.2 Format of SOP:

4.2.1 SOP format shall be prepared under following page setup, as far as possible.

4.2.2 Paper size: A/4

Font size:'X'

Font: 'X'

4.2.3 The SOP shall consist of Header, Footer and Body Part.

4.2.4 Header Part of SOP:

4.2.4.1 The header part of first page shall consists following:

Logo of Company
Name and Address of Company
Standard Operating Procedure
SOP Title
Department
Effective Date
Next Review
SOP No.
Version No.
Supersedes No
Page No.

4.2.4.2 Logo of Company: Mention Logo of the company.

4.2.4.3 Name of Company: Mention name of company in Font Type: 'X', Font Size: 'X', Style: 'X'.

4.2.4.4 Address of Company: Mention address of company in font Type: 'X', Font Size: 'X'.

4.2.4.5 Standard Operating Procedure: Mention STANDARD OPERATING PROCEDURE in Font Type: 'X', Font Size:'X', Style: 'X'.

4.2.4.6 SOP Title: Mention Title of SOP in minimum words which should be self explanatory, Font Type: 'X', Font Size: 'X', Style: 'X'.

4.2.4.7 Department: Mention name of originated department for which SOP is prepared.

4.2.4.8 Effective Date: The effective date shall be hand written in DD/MM/YY or DD/MM/YYYY format and it can be made effective by QA department when SOP preparation, review, approval and training have been completed.

4.2.4.9 Next Review: Mention the review period in DD/MM/YY or DD/MM/YYYY format from which the SOP becomes due for review by hand written by QA. All the SOPs shall be reviewed maximum over a period of two years ± 1 month.

4.2.4.10 If the effective date has date 'n' then next review date should be 'n-1'. For example, effective date is 01/01/17 or 01/01/2017 then next review shall be 01/01/19 or 01/01/2019.

4.2.4.11 SOP No.: Mention unique number of SOP which shall consist of 05 characters (XXYYY).

4.2.4.12 XX = department code as per below given table,
YYY = serial number of SOP which starts form 001,002 so on.

4.2.4.13 All the SOPs shall be numbered in this sequence.

Department Code	Department Name
QA	Quality Assurance Department
QC	Quality Control Department
MD	Microbiology Department
PD	Production Department
HR	Human Resources Department
EN	Engineering
WH	Warehouse Department
PU	Purchase Department
IT	Information Technology Department
RD	Research & Development

4.2.4.14 Version No.: Mention the current version number of the same SOP.

4.2.4.15 Supersedes No.: Mention previous version number of the same SOP which is subjected to revision. If SOP is prepared for the first time, mention None in supersede column.

4.2.4.16 Page No.: Specify page number of the individual as well as total number of pages of SOP.

4.2.4.17 The page number should be specified as Page 'X' of 'Y' where 'X' is actual page number and 'Y' is total page number. Only SOP pages are covered in this section. Pages of formats, records, annexure or attachments are not considered i.e. separate page number will be assign.

4.2.5 Footer Part of SOP:

4.2.5.1 The Every page of SOP footer shall consists of space for pre-printed Prepared By, Reviewed By, Approved By along with name, designation, sign and date.

4.2.5.2 Prepared by, reviewed by and Approved by along with name and designation shall be pre-printed during the preparation of SOP.

4.2.5.3 Sign and date shall be done on hand-written (manually) by respective persons.

4.2.6 Body Part of SOP:

4.2.6.1 The body parts consists of following:

Purpose
Scope
Responsibility
Procedure
Attachments
Abbreviations
Distribution list
References
History of Change

4.2.6.2 Purpose: Briefly describe the purpose and reason for writing the SOP.

4.2.6.3 Scope: Briefly describe the scope and applicability of the SOP.

4.2.6.4 Responsibility: Mention the designation of person(s) who are directly responsible for the Operations mentioned in the purpose of the SOP(s).

4.2.6.5 Procedure:

Prepare all SOPs in clear, easy to understand and easy to follow language.
The content of SOP shall be in chronological order, practical and easy to implement on routine basis.
Avoid usage of overly lengthy sentences & adjectives viz. proper & satisfactory.
Prepare all SOPs in English language.
The SOP, which is to be used by a group of persons, who cannot understand English, shall be prepared in vernacular language along with the English version and the Vernacular language SOP shall undergo the same approval and control mechanism.
SOP which are transcribed in vernacular language, the English version of the respective SOP marked with * at Title to denote that vernacular version of this SOP shall be available.
When do revision of this SOP ensure that the * marked SOPs shall be versionised according to its respective English version.
Format, record, and annexure (except flow chart if required to explain the procedure of SOP) shall not be prepared in the vernacular language.
In case of discrepancy between SOP in English and SOP in vernacular language, the SOP in English version shall be treated as correct version.
Prepare SOPs in present / future verb tense & use verb in active voice.
Prepare description of the activity step by step (sequentially).
Prepare procedure in simple and short sentences, clear language avoiding ambiguous statements, usage of negative words, phrases and long and complex sentences.
While using paragraphs, use maximum two to three sentences.
Keep single line spacing between two sentences if possible.
Mention note / safety / special precautions / instruction wherever necessary.
Use Heads and Sub Heads where necessary in Font Type: 'X', Font Size: 'X', Style: 'X'.
The text shall be in Font Type:'X', Font Size:'X', Style: 'X' and Sentence Case.
In procedures, sub numbering can be given as 4.1, 4.1.1, 4.1.1.1, etc.
Use bullets like , (, (, (, (, , “( etc. for Specific text to be highlighted.
Mention the Calibration / Cleaning frequency, Alert / Action Limit as applicable in procedure.

4.2.6.6 Attachments:

Mention name of appropriate formats, records, annexure, specimen labels (but not limited to) etc. which are need to record the compliance of the SOP. If there is no any format or attachment then mention None.
Attachment no. (Format / record / annexure) shall be given starting from 01, 02, 03 and so on A unique number shall be given to format which shall consists of 12 characters i.e. AABBB-ZXX-YY

where,
AA = Stands for Department Code as mentioned in point no. 4.2.4.13.
BBB= Stands for Serial number of the respective SOP
Z= Stands for Format (F) / Stands for record (R) / Stands for Annexure (A)
XX= Stands for Serial no. of format / record /attachment i.e. 01, 02, so on.
YY= Stands for Revisions made of format / record / annexure. i.e start from 00, 01, so on (with respect to SOP).

6th and 10th character should be -.

As and when any details require to provide for guideline purpose or flow diagram (but not limited to), same shall be provided through Template. Such Template shall be considered as Annexure. Annexure no. shall be given above mentioned procedure.

Prepare Attachment or format / record / annexure as follows:

Mention Logo of the company i.e. in format size: A x B.

Mention name of company i.e. 'XXX' in Font Type: ______, Font Size: ___, Style: 'XXX'.

Mention address of company i.e. 'XXX' in Font Type: ______&, Font Size: __, Style: 'XXX'.

Mention title or name of the format / record / annexure in Font Type: _____, Font Size: __.

Mention Format No. / record no. /annexure no. along with version no , reference SOP No. and Page No.

Format / record / annexure shall be part of SOP and whenever SOP will revised then format / record / annexure shall also revised.

Pre-printed format / record / annexure shall be prepared as per requirement after preparation of format / record / annexure shall be sign and date by respective persons accordingly with appropriate stamp.

4.2.6.7 Abbreviations: Mention all the abbreviation used in the SOP with their full form.

4.2.6.8 Distribution List: Name of department to be mentioned in which SOP to be distributed.

4.2.6.9 References: References shall be mentioned with the help prepared / follow of respective SOP. Reference Shall be recorded (but not limited to) any regulatory guideline, Pharmacopeia, authentic books, party documents / Manual or in-house procedure.

4.2.6.10 History For Change: Mention the history of the SOP for last five revisions which should include Sr. no., Version No., Effective date, change control no. & Reason for revision.

Sr. no.: mentioned the sr. no of sequence

Version No.: Mention the version number along with old version number.

Effective Date: Mention effective date of all existing versions and current version effective date shall be mentioned in handwritten by QA when SOP will effective.

Change control no: Mention change control no with respect to SOP change.

Reason for Revision: Mention reasons for change in brief, if any. In case, if SOP is new and prepared for first time then mention NEW SOP or SOP prepared for first time.

4.3 Preparation, Review, Approval, Revision, Issue, Retrieval and Control of SOP:

4.3.1 SOP shall be prepared by concern person of respective department who has knowledge about the activity / operation. Draft SOP shall be prepared and circulated to the concern department head / Quality Assurance for review, correctness of procedure, methodology and grammatical errors if any.

4.3.2 Make the appropriate changes as per feedback received from the concerned departments head / Quality Assurance and take final print out by respective department. Destroy the draft copies after finalization of the SOP.

4.3.3 The initiating department personnel shall signature along with date (DD/MM/YY or DD/MM/YYYY) in the Prepared By column in blue ink only.

4.3.4 The department head or designee shall review the SOP and signature along with date (DD/MM/YY or DD/MM/YYYY) in the Reviewed By column in blue ink only. The reviewed and duly signed copy shall be submitted to QA head for final approval.

4.3.5 QA Head or designee shall approve the SOP and signature along with date (DD/MM/YY or DD/MM/YYYY) in the Approved By column in blue ink only.

4.3.6 After approval training shall be imparted in the respective SOP. After training SOP shall be distributed. It shall ensure that SOP effective within a month of approval date of SOP and is not prior to the training.

4.3.7 A respective department head or designee or person who has prepared / reviewed / Approved SOP shall impart training to all related concern persons.

4.3.8 SOP shall be made effective within 30 working days from the date of training imparted. SOP should become operational after the effective date.

4.3.9 After finalization of SOP soft copy of SOPs should be submitted to QA department Head, and the same should be deleted from initiators system.

4.3.10 The uncontrolled copy of the SOP shall be issued by QA person to concern department for training purpose. After training uncontrolled copy shall be destroyed by QA persons.

4.3.11 The SOP shall be made effective (DD/MM/YY or DD/MM/YYYY) by QA department in consultation with respective department after completion of SOP training. QA shall written the date in effective date and next review by column of every page of SOP.

4.3.12 Once the SOP is approved, QA personnel shall stamp the SOP and all related formats / records / annexure as MASTER COPY in green colour with all pages on the Top Right Hand Side.

4.3.13 Retain the master copies of all SOPs at QA department in Documentation cell.

4.3.14 For issuance, QA personnel shall take photocopy from master copy of SOP and shall stamp CONTROLLED COPY in blue ink on bottom right hand side of each page of SOP with sign and date by QA officer / designee.

4.3.15 QA Documentation personnel shall enter the distribution details in Distribution, Retrieval & Destruction Record and shall take received by sign in specified column and record of the same shall be maintained.

4.3.16 Whenever SOP is revised, superseded controlled copy shall be retrieved from users and should be destroyed by QA and the same shall be recorded in Distribution, Retrieval & Destruction Record. Document shall be distributed through Distribution, Retrieval & Destruction Record.

4.3.17
If any additional copy is required for department other than the distribution list, same shall be issued and recorded with mention remark Additional Copy.

4.3.18 Department wise list of SOPs (SOP index) shall be prepared by department head / designee for any inclusion or deletion at every six months ± 15 days or as and whenever required prior to six months.

4.3.19 The SOP shall be revised whenever there is any change in the operating procedure or after mandatory review period of two years ± 1 month. If there is no change in SOP, No Changes Reviewed By stamp in red colour shall be made on central of top first & last pages of SOP. Only Two stamps of No Changes Reviewed By shall be allowed.

4.3.20 SOP shall be revised within 30 days from due next review date. The next revision (version) number shall be given to the revised SOP.

4.3.21 QA department shall retain only master copy of old or superseded SOPs in a separate file stamped as OBSOLETE on central middle on the first pages only and shall retained in QA.

4.3.22 For issuing of copy of SOP to outside personnel not for operational use, photo copy of MASTER COPY shall be taken and stamped as UNCONTROLLED DOCUMENT in black colour on central bottom of all pages in SOP.

5.0 Attachments:________________

6.0 Abbreviations:_______________

7.0 References:______________

8.0 History of Change:____________