Preparation, Approval, Issue and Control of Standard Operating Procedure
1.0 OBJECTIVE
To lay down the procedure for preparation, approval, issue, retrieval & control of Standard Operating Procedure (SOP).
2.0 SCOPE
The scope of this Document is to provide the documented system for the preparation and approval of all SOPs prepared for/by various departments. It also explains the distribution control, retrieval and destruction of these SOPs.
3.0 RESPONSIBILITY
3.1 Individual department Personnel for preparation of SOP
3.2 All Plant personnel to follow the written SOP
3.3 Heads of the department to ensure compliance.
3.4 Documentation Cell Personnel for custodian of Master SOPs.
3.5 QA Head for approval and compliance of the SOP.
3.2 All Plant personnel to follow the written SOP
3.3 Heads of the department to ensure compliance.
3.4 Documentation Cell Personnel for custodian of Master SOPs.
3.5 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 -I). Guidelines for filling the format are described below:
Parameter table for designing the SOP
Paper Size: A4 (210 mm X 297 mm)
Paper: White [Company Name] logo paper
Header: Arial, Bold , [Company Name] , Font size: 16 Center, Standard Operating Procedure, Bold, Font size 14 Center and other font size 12.
Footer: Arial, font size 12,
Adjust the header/footer in such a manner that [Company Name] logo is not covered by Header text.
Parameter table for designing the SOP
Paper Size: A4 (210 mm X 297 mm)
Paper: White [Company Name] logo paper
Header: Arial, Bold , [Company Name] , Font size: 16 Center, Standard Operating Procedure, Bold, Font size 14 Center and other font size 12.
Footer: Arial, font size 12,
Adjust the header/footer in such a manner that [Company Name] logo is not covered by Header text.
4.1.1.1 SOP No.: This is a unique number given to each SOP. This number consists of fourteen characters as described below:
4.1.1.1.1 The first three characters are alphabets denoting the procedure code (ie SOP).
4.1.1.1.2 Next character is “/”(Slash)
4.1.1.1.3 The next three characters are department code (Refer annexure III)
4.1.1.1.4 Next character is “/”(Slash)
4.1.1.1.5 Next three characters are numericals starting from 001 in the sequential order within the department.
4.1.1.1.6 Next character is “/”(Slash)
4.1.1.1.7 The last two characters are numericals denoting revision number. The first time any SOP is written, it shall be numbered as “00”. The first revision SOP shall be “01” and so on.
4.1.1.1.8 Example: The first SOP prepared for the first time for Quality Assurance Department shall be numbered as ” SOP/QAD/001/00″ and the same when revised for first time shall be numbered as ” SOP/QAD/001/01″.
4.1.2 Supercedes and Page No .:
Supercedes is the SOP No. Of preceding SOP to be discontinued. In case existing SOP of particular Department shall be covered in the revision of other department SOP in that case supercedes both the department SOP and mention in Change history.
Supercedes is the SOP No. Of preceding SOP to be discontinued. In case existing SOP of particular Department shall be covered in the revision of other department SOP in that case supercedes both the department SOP and mention in Change history.
Give the specific page number as well as the total pages comprising the Standard Operating Procedure. Example: 1 of 5.
4.1.3 Department:
Give the name of the Department to which the SOP pertains.
Example: Quality Assurance.
Give the name of the Department to which the SOP pertains.
Example: Quality Assurance.
4.1.4 Title:
Give the detailed heading of the SOP.
Give the detailed heading of the SOP.
4.1.5 Effective Date:
The effective date is the date when the contents of SOP become operative, after training of the concerned personnel on the SOP, which shall be hand written with blue colour ink.
The effective date is the date when the contents of SOP become operative, after training of the concerned personnel on the SOP, which shall be hand written with blue colour ink.
4.1.6 Review Date:
Indicates the date before which the SOP shall be reviewed. This shall be two years from the Effective Date. The Period of review shall be + 30 days of the review date mentioned in the SOP, which shall be hand written with blue coloured ink.
Indicates the date before which the SOP shall be reviewed. This shall be two years from the Effective Date. The Period of review shall be + 30 days of the review date mentioned in the SOP, which shall be hand written with blue coloured ink.
4.1.7 Prepared by/Date:
The person, who prepares the SOP, shall sign with date in this column. The operating personnel of the respective department shall prepare the SOP.
The person, who prepares the SOP, shall sign with date in this column. The operating personnel of the respective department shall prepare the SOP.
4.1.8 Checked by/Date:
Each SOP shall be checked by Head of the functional department or his designee. The approving authority shall ensure suitability of the SOP for cGMP compliance.
Each SOP shall be checked by Head of the functional department or his designee. The approving authority shall ensure suitability of the SOP for cGMP compliance.
4.1.9 Approved by/Date:
Every SOP shall be approved by the Head-QA or his designee.
Every SOP shall be approved by the Head-QA or his designee.
4.1.10 The SOPs should have following headings and details:
4.1.10.1 OBJECTIVE:
State the reason why something is sought or aimed for writing the SOP. Start the sentence with “To”. This elaborates the usefulness of the SOP (elaborates on “What / Why”)
State the reason why something is sought or aimed for writing the SOP. Start the sentence with “To”. This elaborates the usefulness of the SOP (elaborates on “What / Why”)
4.1.10.2 SCOPE:
State the activity, area, process, equipment as appropriate for which the SOP shall be applicable.
State the activity, area, process, equipment as appropriate for which the SOP shall be applicable.
4.1.10.3 RESPONSIBILITY:
State the person responsible for performing the described activity and responsible for the compliance of the SOP.
State the person responsible for performing the described activity and responsible for the compliance of the SOP.
4.1.10.4 PROCEDURE:
Write stepwise activity to be carried out for each procedure in simple, easily understandable language or languages. It shall be in verbatic and logistic order.
Write stepwise activity to be carried out for each procedure in simple, easily understandable language or languages. It shall be in verbatic and logistic order.
4.1.10.5 ANNEXURE
Mention the list of attachments of individual SOP.
Mention the list of attachments of individual SOP.
4.1.11 Procedure for format numbering system
4.1.11.1 Shall include appropriate formats, Product labels etc., needed to record the compliance of the SOP.
4.1.11.2 Each format shall be given a number. The number consists of 17 characters.
4.1.11.2.1 The first three letters denote Location Code (LC)
4.1.11.2.2 Next character is “/”(Slash)
4.1.11.2.3 The Second three letters denote department code as mentioned in Annexure – III
4.1.11.2.4 Next character is “/”(Slash)
4.1.11.2.5 The next three characters denote serial number of the SOP.
4.1.11.2.6 Next character is “/”(Slash)
4.1.11.2.7 The next two denote the serial number of the Format for that particular SOP.
4.1.11.2.8 Next character is “/”(Slash)
4.1.11.2.9 The last two characters denote revision number of the respective format.
Example: (LC)/QAD/001/01/00 is the first format, made first time and related to first SOP of QA department and if it is revised first time shall be numbered as (LC)/QAD/001/01/01.
Example: (LC)/QAD/001/01/00 is the first format, made first time and related to first SOP of QA department and if it is revised first time shall be numbered as (LC)/QAD/001/01/01.
4.1.11.3 Format No. shall appear on right top of the format in the header of the SOP.
4.1.11.4 A specimen of each format shall be enclosed with respective SOP and stamped as “Specimen” in blue colour in the middle of the document and signed with date by the Head of Quality Assurance or his designee.
4.1.11.5 If any flow chart, Informative contents etc. in the SOP in between two formats shall not be given format no.
4.1.11.6 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.
4.1.12 Submission of New SOP:
4.1.12.1 The initiator of the SOP shall prepare a draft copy of the proposed SOP based on the above guidelines and forward it to the Department Head/Functional Department Head for Checking.
4.1.12.2 Once checked and accepted by the Department Head/Functional Department Head, the same shall be routed for approval of the Head of Quality Assurance for his inputs & recommendations.
4.1.12.3 A disagreement on any aspect of the SOP from any one of the concern personnel shall stop immediately, ‘New SOP submission’ shall be done until all concern personnel come to an agreement on the proposed new SOP.
4.1.12.4 The Original copy of the SOP shall be prepared, checked and approved with signature and date. The effective date shall be entered after training the concerned personnel on the new SOP.
4.1.12.5 The SOP shall be made effective within 21 days after training of concern personnel conducted.
4.1.12.6 In case if failed to make effective, retraining shall be conducted with suitable justification and then SOP shall be made effective.
Note: All the signature and entries in master copy shall be done with blue ink.
4.1.13 Review procedure of SOP:
4.1.13.1 Every SOP shall be reviewed at the end of two years or need basis from the effective date by the concerned personnel and the Head of the Department.
4.1.13.2 During review or as and when any changes are desired or deemed necessary, the changes shall be initiated through a ‘Change Control Form ‘ as per SOP on ‘Change Control Program’.
4.1.13.3 Whenever SOP is reviewed, the changes made shall be entered in the ‘Change History’ (Annexure-IV) and attached at the end of the SOP.
4.1.13.3.1 In “SOP No. Column” revised SOP number shall be entered.
4.1.13.3.2 Give Point number of previous SOP in “Reference Point” column.
4.1.13.3.3 Give revised detail related to point number mentioned in Reference Point includes :
4.1.13.3.3.1 Revised Point text
4.1.13.3.3.2 Revised Point No. if it is revised.
4.1.13.3.3.3 Justification for revision (if required)
4.1.13.4 The reviewed and approved SOP shall be made effective after training of concerned personnel.
4.1.13.5 In case there are no changes required in the existing SOP during review, then the same SOP shall be valid for the next two years with no change in the revision number or effective date and put red colour stamp as reviewed by with sign and date and next review date on top of the sop as per annexure V.
4.1.14 Distribution and Control of SOP:
4.1.14.1 The original copy of the SOP shall have the original signatures and shall be maintained at Documentation cell.(QA)
4.1.14.2 Issue of the SOP shall be controlled by QA department.
4.1.14.3 Documentation personnel shall take the photocopy of the SOPs from the original copy.
4.1.14.4 Documentation personnel shall stamp as issued by, issued to and user copy number on the top left hand side of the SOP in violet colour, sign with date and issue the copy to the concerned Department/Section/Area.
4.1.14.5 If need arises for an additional copy of SOP, the concerned Head of the Department shall make request to Head of Quality Assurance Department.
4.1.14.6 Head – QA shall arrange for the issue of a copy of the requested SOP.
4.1.14.7 The details of issuance shall be recorded in Issue record (Annexure-II).
4.1.14.8 Photocopying of any issued SOP is prohibited.
4.1.14.9 Any SOP issued for non-operational use shall be stamped as ‘Uncontrolled Copy, Not for Operational Use’ in green colour, with signature of Head of Quality Assurance Department or his designee on first page only and rest all page shall bear the stamp only.
4.1.14.10 User copies of old and superseded SOPs shall be returned to QA department. Document controller (QA) shall ensure reconciliation and destruction. The destruction details shall be entered in “Issue Record” (Annexure-II). The Original copy shall be stamped as “Obsolete – For reference only” in red colour in the middle (diagonally) of the document and stored in documentation cell.
Note: In case of system related SOP “flow chart” shall be prepared and it shall be enclosed in SOP.(Where ever applicable)
Note: In case of system related SOP “flow chart” shall be prepared and it shall be enclosed in SOP.(Where ever applicable)
5.0 ANNEXURE (S):
Annexure – I: SOP format
Annexure – II: SOP Distribution, Retrieval & Destruction Record
Annexure – III: Departmental Codes
Annexure – IV: Change History
Annexure – V: Specimen of Stamping
Annexure – IV: Change History
Annexure – V: Specimen of Stamping