SOP for SOP, Purpose :
SOP for SOP, The purpose of this SOP is to define the stages, responsibilities and structure for the creation, distribution, handling, controlling, revision & retrieval of all operating procedures of XX Pharmaceuticals Ltd.
SOP for SOP, Scope :
This SOP applies to all functions in order to prepare, review, control and authorize/approve any procedure.
Definitions / Abbreviation:
[][]Standard Operating Procedure (SOP): A written authorized procedure, which gives instructions for performing operations.
Responsibilities:
[][]The roles and responsibility is as follows:
Author(Who prepares the SOP)
[][]Ensure that the document is technically correct and reflects the required working practices.
[][]Initiate the preparation of SOP through the inputs from the employees directly concerned with the activity.
[][]Responsible for circulation of SOP for comment and resolution of any differences of opinion.
Technical Expert
(Any person who has basic understanding on the subject matter)
[][]Review the SOP and formally notify their agreement to SOP owner within a stipulated time.
Functional Head
[][]To confirm the content, accuracy and detailing about of SOP.
[][]Verify the SOP against XX Pharmaceuticals Ltd. master documents and current regulatory requirements and approve it.
Quality Assurance Executive
[][]To maintain the original copy of the SOP.
[][]To issue controlled copy of the SOP and maintain issuance record.
[][]To retrieve the controlled copy of the SOP when it is superseded.
[][]To destroy the SOP as per procedure.
[][]To control and monitor the review process of the SOP.
Manager, Quality Assurance
[][]Approve all SOPs that have direct/indirect impact on product quality.
Procedure:
[][]Note: It will be applicable for any SOP of general precautions or operational safety.
[][]The process for developing and managing any SOP includes picking of right format, number generation, drafting, review, approval, issuance, distribution, periodic review, revising, withdrawing, archiving and destruction.
[][]Layout Designing for SOP: Before preparation of a SOP, following preliminary requirements are to be meet:
Format of SOP
[][]Standard Format (Annexure-I) shall be used for preparing any Standard Operating Procedure.
[][]The format of this SOP should be used to maintain the same text fonts, page borders, and general document format as explained here.
| Particulars | Font size | Font | Font Style |
|---|---|---|---|
| In Header: Company Logo | N/A | N/A | Position is ‘Left side’ |
| In Header: Company Name | 14 | Arial | Bold, All Letters in Capital, Position is ‘Centered’ (both in Horizontally & Vertically) |
| In Header: Plant Address | 08 | Arial | All words are Regular but “Plant” is in bold. Position is ‘Centered’ (both in Horizontally & Vertically) |
| SOP Title | 10 | Arial | Bold & Uppercase |
| Heading | 10 | Arial | Bold |
| Text | 10 | Arial | Regular |
| In footer | 10 | Arial | Bold, Position is ‘Left (indent)’ in Horizontally & ‘Centered’ in Vertically |
Page Set Up
Margin:
[][]Top : 0.75
[][]Bottom : 0.75
[][]Right : 0.75
[][]Left : 0.75
[][]Gutter : 0.00
[][]Header : 0.5
[][]Footer : 0.5
Note: All Measurements at Inch.
[][]Paper size: A4 size, offset paper
[][]Orientation: Portrait (However landscape orientation may be used for annexure or if required).
[][]Header: Same for all pages [Annexure-I]
[][]Footer: Same for all pages except first. In first page there is no footer. [Annexure-I].
[][]Heading of the main content should use appropriate heading number such as 1, 2, 3 etc.
[][]Subheading may be included in any of the content sections using appropriate heading numbering such as 1.1, 1.2 etc.
[][]Further subheading may be included in any of the sub content sections using appropriate heading numbering such as 1.1.1, 1.1.2 etc.
[][]Header & Footer: Each page header must contain the following information:
[][]Title: Mention title of the SOP, which is expressive of the subject of the SOP.
[][]SOP Number: All the SOP numbers must be unique, unambiguous and unanimous. Referencing should be done in such a manner that it reflects either the function or purpose of this SOP. Standard format of SOP number is as – ‘SOP /Sectional Ref/Sequential SOP No. / Version No.’
[][]Sectional Reference is the predefined department/Section code to identify the SOP controlling department.
The following ‘Sectional Ref’ numbers must be used at the time of preparation of SOPs.
[][]Production (General): PRO
[][]Production (Sterile): S-PRO
[][]Packaging (General): PKG
[][]Packaging (Sterile): S-PKG
[][]Warehouse (General): WH
[][]Warehouse (Sterile): S-WH
[][]Quality Assurance (General): QA
[][]Quality Assurance(Sterile): S-QA
[][]Quality Control(General): QC
[][]Quality Control(Sterile): S-QC
[][]Microbiology(General): MIC
[][]Microbiology(Sterile): S-MIC
[][]Product Development(General): PD
[][]Product Development(Sterile): S-PD
[][]Engineering: ENG
[][]HR & Admin: HR
[][]Supply Chain: SC
[][]Information Technology: IT
[][]Environment, Health &safety: EHS
A three digit Sequential number shall be assigned to the SOP. This number cannot be reassigned to any other SOP even after deletion of that SOP. The sequential number will be followed by two digit Version number which indicates the number of the revision of the respective SOP.
[][]Version No: In case of new SOP, mention “01” in this column. In case of revision, mention number of version in this column.
[][]Superseded: In case of new SOP, mentions “N/A” in this column. In case of revision, SOP No. of old version shall be written in this column.
[][]Page No.: Mention page No. in this column. It shall be mentioned in “Page X of Y” format.
[][]Prepared By (Signature in Blue Ink on Every Page): Signature of a person, who has written the SOP, shall appear in this column. The signature shall be done using a blue ink to identify the copy as master copy.
[][]Checked By (Signature in Blue Ink on Every Page): Signature of Head of SOP Controlling Department /User department head or any concerned reviewer, who has checked the SOP, shall appear in this column.
[][]Agreed By: Signature of Head of other departments excluding SOP owner /User department head or any concerned reviewer, who has checked & agreed the SOP, shall appear in this column.
[][]Define Content of SOP: Every SOP must contain the following standard sections and contents. Guide line to write these contents is in below:
[][]Issue Date: This is the date when the SOP is issued for signature/approval. This should be in the day-month-year (dd-month-yyyy) format i.e. 30-August-2012.
[][]Effective Date: Mention the effective date from which the SOP shall be implemented after proper training. This should be within 7 working days of approval.
[][]Review Date: It will be 36 months from the issue date in day-month-year (dd-month-yyyy) format. However, revision may be made as and when required before schedule.
[][]Review and Approval: This section must include the printed name, signature, job title, and signing date for the following four disciplines:
[][]Prepared by
[][]Checked by
[][]Agreed by( it would be included where necessary)
[][]Approved by
[][]Distribution List: This section will have a list with job title of individual or sectional name to which the SOP will be distributed for execution.
[][]Purpose: The purpose must state why the SOP is needed
[][]Scope: Mention the application of the SOP in this section. It shall describe the extent of areas covered by the SOP. If the same SOP is used in different location, mention the location in the scope of that SOP.
[][]Definition / Abbreviation: Definitions of words, abbreviations, or actions that may not be readily understandable.
[][]Responsibility: Briefly describes the detailed responsibilities of individuals/departments for implementation of the SOP.
[][]Revision Details: In case of revision, point out the specific changes of current version with previous version. For a new SOP the Revision Details text must read: “First issue”.
[][]Annexure: The mandatory features of an annexure are:
Annexure-I: Format of SOP
Annexure-II: SOP Issue Register
Annexure-III: Request for Issuance of Additional copy of SOP
Annexure-IV: Authorization for Discontinuation of SOP
Procedure:
[][]Note: It will be applicable for any SOP of general precautions or operational safety.
[][]The process for developing and managing any SOP includes picking of right format, number generation, drafting, review, approval, issuance, distribution, periodic review, revising, withdrawing, archiving and destruction.
[][]Layout Designing for SOP: Before preparation of a SOP, following preliminary requirements are to be meet:
[][]Format of SOP
[][]Standard Format (Annexure-I) shall be used for preparing any Standard Operating Procedure.
[][]The format of this SOP should be used to maintain the same text fonts, page borders, and general document format as explained here.
| Particulars | Font size | Font | Font Style |
|---|---|---|---|
| In Header: Company Logo | N/A | N/A | Position is ‘Left side’ |
| In Header: Company Name | 14 | Arial | Bold, All Letters in Capital, Position is ‘Centered’ (both in Horizontally & Vertically) |
| In Header: Plant Address | 08 | Arial | All words are Regular but “Plant” is in bold. Position is ‘Centered’ (both in Horizontally & Vertically) |
| SOP Title | 10 | Arial | Bold & Uppercase |
| Heading | 10 | Arial | Bold |
| Text | 10 | Arial | Regular |
| In footer | 10 | Arial | Bold, Position is ‘Left (indent)’ in Horizontally & ‘Centered’ in Vertically |
Page Set Up
Margin:
[][]Top: 0.75
[][]Bottom: 0.75
[][]Right: 0.75
[][]Left: 0.75
[][]Gutter: 0
[][]Header: 0.5
[][]Footer: 0.5
[][]Paper size: A4 size, offset paper
[][]Orientation : Portrait (However landscape orientation may be used for annexure or if required).
[][]Header : Same for all pages [Annexure-I]
[][]Footer: Same for all pages except first. In first page there is no footer. [Annexure-I].
[][]Heading of the main content should use appropriate heading number such as 1, 2, 3 etc.
[][]Subheading may be included in any of the content sections using appropriate heading numbering such as 1.1, 1.2 etc.
[][]Further subheading may be included in any of the sub content sections using appropriate heading numbering such as 1.1.1, 1.1.2 etc.
[][]Header & Footer: Each page header must contain the following information:
[][]Title: Mention title of the SOP, which is expressive of the subject of the SOP.
[][]SOP Number: All the SOP numbers must be unique, unambiguous and unanimous. Referencing should be done in such a manner that it reflects either the function or purpose of this SOP. Standard format of SOP number is as – ‘SOP /Sectional Ref/Sequential SOP No. / Version No.’
[][]Sectional Reference is the predefined department/Section code to identify the SOP controlling department.
The following ‘Sectional Ref’ numbers must be used at the time of preparation of SOPs.
[][]Production (General): PRO
[][]Production (Sterile): S-PRD
[][]Packaging (General): PKG
[][]Packaging (Sterile): S-PKG
[][]Warehouse (General): WH
[][]Warehouse (Sterile)S-WH
[][]Quality Assurance (General): QA
[][]Quality Assurance(Sterile)S-QA
[][]Quality Control(General): QC
[][]Quality Control(Sterile): S-QC
[][]Microbiology(General): MIC
[][]Microbiology(Sterile): S-MIC
[][]Product Development(General): PD
[][]Product Development(Sterile):S-PD
[][]Engineering: ENG
[][]HR & Admin: HRD
[][]Supply Chain: SC
[][]Information Technology: IT
[][]Environment, Health & Safety: EHS
A three digit Sequential number shall be assigned to the SOP. This number cannot be reassigned to any other SOP even after deletion of that SOP. The sequential number will be followed by two digit Version number which indicates the number of the revision of the respective SOP.
[][]Version No: In case of new SOP, mention “01” in this column. In case of revision, mention number of version in this column.
[][]Superseded: In case of new SOP, mentions “N/A” in this column. In case of revision, SOP No. of old version shall be written in this column.
[][]Page No.: Mention page No. in this column. It shall be mentioned in “Page X of Y” format.
[][]Prepared By (Signature in Blue Ink on Every Page): Signature of a person, who has written the SOP, shall appear in this column. The signature shall be done using a blue ink to identify the copy as master copy.
[][]Checked By (Signature in Blue Ink on Every Page): Signature of Head of SOP Controlling Department /User department head or any concerned reviewer, who has checked the SOP, shall appear in this column.
[][]Agreed By: Signature of Head of other departments excluding SOP owner /User department head or any concerned reviewer, who has checked & agreed the SOP, shall appear in this column.
[][]Define Content of SOP: Every SOP must contain the following standard sections and contents. Guide line to write these contents is in below:
[][]Issue Date: This is the date when the SOP is issued for signature/approval. This should be in the day-month-year (dd-month-yyyy) format i.e. 30-August-2012.
[][]Effective Date: Mention the effective date from which the SOP shall be implemented after proper training. This should be within 7 working days of approval.
[][]Review Date: It will be 36 months from the issue date in day-month-year (dd-month-yyyy) format. However, revision may be made as and when required before schedule.
[][]Review and Approval: This section must include the printed name, signature, job title, and signing date for the following four disciplines:
[][]Prepared by
[][]Checked by
[][]Agreed by( it would be included where necessary)
[][]Approved by
[][]Distribution List: This section will have a list with job title of individual or sectional name to which the SOP will be distributed for execution.
[][]Purpose: The purpose must state why the SOP is needed.
[][]Scope: Mention the application of the SOP in this section. It shall describe the extent of areas covered by the SOP. If the same SOP is used in different location, mention the location in the scope of that SOP.
[][]Definition / Abbreviation: Definitions of words, abbreviations, or actions that may not be readily understandable.
[][]Responsibility: Briefly describes the detailed responsibilities of individuals/departments for implementation of the SOP.
[][]Revision Details: In case of revision, point out the specific changes of current version with previous version. For a new SOP the Revision Details text must read: “First issue”.
[][]Annexure: The mandatory features of an annexure are:
[][]No annexure can be updated without updating the SOP.
[][]No need to update Annexure during only updating the SOP.
[][]Procedure: This section provides the detailing about the step-wise activities to be performed within a system.
[][]Preparation of SOP:
[][]SOP author will prepare a procedure in clear unambiguous language which describes the process to be conducted against the SOP in sufficient detail that they can be performed in a reproducible, systematic and consistent manner. During preparation of SOP author must consider the following:
[][]Understand the full process first and then write the procedure/SOP.
[][]Write procedure using simple, clear, concise & easy sentences.
[][]Abbreviations must be defined in full on the first occasion of use. All the resources that can give ideas about preparing the procedure shall be explored.
[][]It is preferable to use positive sentence structure in the SOP.
[][]High level process flowcharts or diagrams must be used for clear understand of the process
[][]User Department Head confirms the content, accuracy and detailing of SOP.
[][]Review of the Documents:
[][]The author collect all comments from the review of the document and update the document as appropriate and be able to provide the Approvers with a justification for any comments from key reviewers that are not accepted.
[][]Approval of SOP:
[][]After final verification, All SOP’s must be approved by Manager, Quality Assurance.
[][]Training on SOP:
[][]After final sign off the originator or controlling department will initiate the training program on SOP.
[][]Training must be conducted before the effective date of the SOP.
[][]The originator will inform to Human Resources Department [HR] with a formal request for organizing training.
Issue of SOP:
[][]SOP controlling department will make required photocopies of the SOP from Master SOP as per distribution list.
[][]Put the “CONTROLLED” stamp in blue ink at the top of the right side of each page of the SOP.
[][]Controlling Department issues the SOP for implementation after making necessary entries in the controlled copy issuance record (Annexure-II) at the time of issuing. The record sheet will be attached with master SOP.
[][]Controlling Department will retrieve all controlled copies of the superseded version.
[][]Controlling Department person shall put the “OBSOLETE” stamp (sample is given below) in red colour on each page of the Master SOP of the superseded version. The Controlling
[][]Department shall keep the OBSOLETE MASTER SOP in the master OBSOLETE file.
[][]All other copies of superseded version will be destroyed after keeping a record.
[][]Photocopy of the “CONTROLLED COPY” is not permitted.
[][]Any photocopy that is not having blue stamp of “CONTROLLED” shall not be considered valid for use.
[][]Master SOP will be kept by Quality Assurance department.
[][]There shall be a Master List of all main SOPs and it shall be maintained by Quality Assurance Department.
Implementation:
[][]The user department after receiving “CONTROLLED” copy of the new SOP shall implement the SOP after training.
Periodic review of SOP:
[][]SOP shall be reviewed at least every 3 years. However SOP’s may be revised before the next review date if required.
[][]In case of any change in the SOPs that may affect the product quality a Change Control Proposal shall be raised by the user’s section/department.
Issuance of Additional Copy of SOP:
[][]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 Manager, quality [][]Assurance. Such requests shall be obtained through the Request Form as per Annexure -III and shall be forwarded through the department head.
Discontinuation of the SOP:
[][]The existing SOP may be discontinued with proper justification and approval of Departmental Head / Manager, Quality assurance. The SOP number of deleted SOP cannot be reassigned to any other SOP. Fill the details for discontinuation of the SOP as per Annexure-IV.
[][]QA person shall retrieve and destroy all the controlled copies of the discontinued SOP after the authorization of Manager, Quality assurance.
[][]QA person shall put the ‘OBSOLETE’ stamp in red color on the every page of the original copies of the discontinued SOP.
Annexure:
Annexure-I: Format of SOP
Annexure-II: SOP Issue Register
Annexure-III: Request for Issuance of Additional copy of SOP
Annexure-IV: Authorization for Discontinuation of SOP
Annexure-V: SOP Index