Preparation, approval, distribution control, revision and destruction of Standard Operating Procedure (SOP)

SOP Approval
Head Operations	Head QA

1.0		OBJECTIVE:
		To lay down a procedure for preparation, approval, distribution control, revision and destruction of SOP.
2.0		SCOPE:
		The scope of this document is to provide the guidelines for preparation and approval of all Standard Operating Procedures prepared for activities related to department function by concerned department personnel. It also explains the distribution control, revision and destruction of these Standard Operating Procedures including this procedure.
3.0		RESPONSIBILITY:
		Officer /Executive – QA: For preparation and execution of the SOPs. Manager –QA: To ensure the compliance all SOPs.
4.0		PROCEDURE:
4.1		Preparation procedure:
4.1.1		The format for the SOP structure is provided in Annexure – I.
4.1.2		Use A4 size (Width: 8.27” and Height: 11.69” approximately) white paper.
4.1.3		Format SOPs with the following margins. Top: 1.0”, Bottom: 0.5”,  Left : 1.0”,     Right : 0.7”, Header : 0.7” and Footer : 0.7” approximately.
4.1.4		Prepare SOPs  “Arial” font with font size “12” approximately.
4.1.5		Prepare SOPs in a clear, unambiguous, easy to understand and easy to follow language. SOP shall be prepared in draft form as required & printed with ‘’DRAFT’’ only .The draft copy shall be circulated for checking and shall be retained upto approval.
4.1.6		All SOPs prior to issue shall be checked and approved.
4.1.7		All SOPs shall be prepared with following subheadings, 4..1.7.1       Objective 4..1.7.2       Scope 4..1.7.3       Responsibility 4..1.7.4       Procedure 4..1.7.5       Annexure(s) 4..1.7.6       Reference (s) 4..1.7.7       Abbreviation(s) /Definition (S) 4..1.7.8       Revision Card
4.1.8		The following details as given under each of the above mentioned                           ( Step No. : 4.1.7 ) subheadings shall be entered .
4.1.8.1		OBJECTIVE State the reason for writing the SOP. Restrict the reason to one sentence or maximum two sentences statement, starting with the word “To”.
4.1.8.2		SCOPE State the scope to which this SOP shall be applicable for. The scope shall be applicable for processes / equipment / policies/ particular section/site.
4.1.8.3		RESPONSIBILITY State the designation of the person who is competent enough / operating person responsible for performing the job as described in SOP. Care must be taken to ensure that preferably one to two persons are responsible for compliance of SOP.
4.1.8.4		PROCEDURE Give in short, unambiguous sentences of the operating procedure, all checks to be done, record to be maintained, frequency of various operations, etc. Give special precautions, if any. SOP must not have long paragraphs but in short, a few sentences paragraphs. Special instructions may be given as ‘ Note’ , ‘ Precautions’ etc.
4.1.8.5		ANNEXURE (S) Give the Annexure (s) used in SOP
4.1.8.6		REFERENCE (S) The references referred to prepare the SOP/Document shall be mentioned under this heading without version no. The document no/ SOP no and title shall be mention.
4.1.8.7		ABBREVIATION (S) / DEFINITION (S) State the Abbreviation(s) used in SOP or State the Definition of necessary phrases and words present in SOP.
4.1.8.8		REVISION CARD State serial no., revision no., revision date, details of revision and reason(s) for revision, reference change control No.   The revision card shall note the history of revision and be part of the master copy to be circulated as per requirement.
4.1.9		Each SOP shall have a header and footer with the following details.
4.1.9.1		ITEM – I: Header of the all pages will have the word “Restricted Circulation” on the top right hand side corner, above the header.
4.1.9.2		ITEM – II: Name of the company with address of the site and logo of the company.
4.1.9.3		ITEM – III:  STANDARD OPERATING PROCEDURE
4.1.9.4		ITEM – IV: Department, Mention respective department for which the SOP is being written or who has major responsibility to accomplish the job / tasks.
4.1.9.5	ITEM- V: SOP No., Mention a unique number to each SOP. First seven characters shall be consider as SOP number and last three characters( 8th , 9th &10th) shall be consider as sop version number or revision number, broken down as follows ;
	XXX		/	XXX	-	XX
	First three characters		4th character	5th, to 7th character	8th Character	9th & 10th character
	Department Code*		Forward Slash	Serial No.	Hyphen	Revision No.
	( ‘X’ In capital alphabetic letters) The First ( 1st  ) three characters are letters of the alphabet denoting the
	“Department Code (alphabetic)” for which SOP is being written for as per annexure IV.
		Ø  4th character denotes ”/ “ (Forward Slash).
		Ø  5th, 6th and 7th character denotes “serial number of SOP” (A three-digit number starting serially from 001).
		Ø  8th character denotes “- ’’(hyphen).
		Ø  9th & 10th character denotes “Revision No.”  If any new SOP is written, it will be numbered as “00”. The next revision will be numbered as “01”.
4.1.9.6		ITEM- VI: Title, Mention the title of the SOP for which it is being prepared.
4.1.9.7		ITEM – VII: Supersedes, Mention previous revision number. Write “Nil”, if the new SOP is written.
4.1.9.8		ITEM – VIII: Issue Date, Mention the month & year when this SOP is issued to the respective department.
4.1.9.9		ITEM – IX: Effective Date, Mention the month & year when this SOP is scheduled to be effective and the SOP shall be effective after training of this SOP.

4.1.9.10	ITEM – X: Review Date; Mention the month & year for review of SOPs. (Two years from the effective date), SOPs Shall be reviewed during this month. However any change in SOP, can be brought on need basis.  It will require a revision and re-issuance of the same as and when the change is implemented.
4.1.9.11	ITEM – XI: Page No., Mention the running page number followed by the total page number (CURRENT PAGE of TOTAL NUMBER OF PAGES).For example page no. 4 of 5 , 5 of 5.
4.1.9.12	ITEM – XII: SOP approval: On first page of SOP below the header approval Signature ·         Approved by: shall be signed by Operational Head and QA Head
4.1.9.13	ITEM – XIII: Each SOP footer shall have following details:
	·         Prepared by : shall be signed by a person responsible for executing the SOP. ·         Reviewed by: Shall be signed by Head Of Department or his designee, and From QA who review the SOP and format.
	Each signatory shall sign in blue pen and put the date of signature.
4.1.10	Each signature column shall mention the designation of the person, signature & date of signatory & name of the signatory.

4.1.11	Quality Assurance department shall take photocopy of same SOP and distribute it as per the following Distribution and Control Procedure.
4.2	Distribution and Control Procedure:
4.2.1	After receiving the soft copy of SOP from the concern department. Documentation cell person shall review the documents for its accuracy and adequacy such as but not limited to: ·         Format & Format No. ·         Page Numbering ·         Typographical errors ·         Compliances with Change control ·         Other affected documents
4.2.2	Documentation cell person shall take the printout and stamp as “Originated By” with red colour ink on left bottom of first pages and put the signature/date. This hard copy shall be forwarded to concern department for signature.
4.2.3	After approval of SOP training shall be imparted if required before SOP is scheduled to be effective.
4.2.4	Quality Assurance department shall keep all approved SOPs (Master Copy in safe custody).
4.2.5	The Quality Assurance department shall stamp the SOPs as described below using the standard stamps as given in Annexure – II.
4.2.6	Original copy shall be stamped as “MASTER COPY” in red ink on the front top right hand side corner of all the pages. The annexures in the SOP shall be also stamped with “Approved” stamp in red ink on the top left corner.
4.2.7	Quality Assurance department shall photocopy the “MASTER COPY” and stamp as “CONTROLLED COPY / DEPT. CODE NO.” in red ink on the front centre bottom side of all the pages. It shall be signed by Quality Assurance person controlling the SOPs or nominated person and allot a specific number to each department. Department code No. is allotted to various departments is as per annexure IV.
4.2.8	Quality Assurance department shall control distribution of all SOPs. The details of distribution will be entered in “Document Distribution Record” as per SOP QAD/005.
4.2.9	For displaying on the site, photocopy of “MASTER COPY’’ shall be taken and stamped as “REFERENCE COPY / DEPT. CODE NO.” in green ink on the bottom right hand side corner of all the pages and It shall be signed by Quality Assurance person. Number of reference copy issued to department shall be recorded in the “Document Distribution Record” as per SOP QAD/005.
4.2.10	Any photocopy of SOP(s) required by external agencies other than regulatory / statuary / legal authorities shall be issued based on request and shall be approved by Head – QA. Quality Assurance Department will issue a photocopy of “MASTER COPY’’ stamped as “UNCONTROLLED COPY” in black ink at the bottom right hand side corner on all the pages.

4.3	Revision Procedure:
4.3.1	Revision of SOP shall be done at any time on need basis. It shall be reviewed at the end of two years from the effective date. The SOP’s change shall follow the steps as detailed in the change control system as per SOP QAD/030
4.3.2	SOP to be reviewed, all “CONTROLLED COPY” and “REFERENCE COPY” shall be returned to Quality Assurance department, and will be entered in the “Document Distribution Record” as per SOP QAD/005.
4.3.3	Quality Assurance Department shall ensure reconciliation and destroy the controlled and reference copies received from different departments and enter in the “Document Distribution Record” as per SOP QAD/005.
4.3.4	The old “MASTER COPY” maintained in the Quality Assurance department shall be stamped “OBSOLETE” in red ink and stored / archived for history purpose.
4.3.5	Serial No., revision No., revision date, details of revision and reason of revision, reference change control no for revision of of SOP shall be clearly mentioned in the last item of the SOP. i.e. revision card.
4.3.6	If there is no change in text of SOP, stamp “REVIEWED BY / DATE’’ and ‘’NEXT REVIEW DATE” in red ink at the bottom left hand side corner of all the pages of  “MASTER COPY” shall be put. However, this will not limit the change in SOP, if required.
4.3.7	The revised SOPs shall once again go through the same procedure of approval, authorization and distribution control as mentioned earlier.
4.4	Destruction procedure:
4.4.1	Retrieved copies of SOP shall be destroyed by any one of the following methods. 1.    Shredding 2.    Incineration Quality Assurance department shall supervise this activity.
	Note : Ø  The SOP shall be translated to local language whenever required. Ø  The list of SOP for local language shall be prepared. Ø   If any English SOP changes, the same version of local language shall be changed at same time. Ø  The SOP shall be prepared based on reference, such as pharmacopoeia or manufacturer recommendation or specific guidelines as applicable. Ø  The index of SOP shall be revised every 3 months if any changes of SOPs or before any regulatory audit, if required. Only last version copy of the index shall be kept in archival. Ø  The index of SOP shall be controlled as per point no. 4.2. Ø  No person shall make changes to the SOP without authorization, and any change must be approved before implementation.

7.0		ABBREVIATION (S) /DEFINITION (S) :
		Dept.   :           Department FG       :           Finished Goods PM      :           Packing Material QA      :           Quality Assurance QC     :            Quality Control RM      :           Raw Material SOP    :           Standard Operating Procedure

      Note:        Any additional information / attachment can be given as per requirement of SOP.