Standard Operating Procedures- SOP on SOP in Industry (Pharmaceuticals Industry)
SOP in Industry stands for “standard operating procedure,” a set of step-by-step instructions for completing a task, An SOP goes beyond being just a procedural document it serves as a reference guide for problem-solving, a tool for ensuring safety, and a mechanism for standardizing performances across the organization.SOP is used across an organization for many different types of tasks, SOPs help ensure consistency and quality in job performance. Companies use SOPs both for new hires and for training existing team members on new equipment, procedures, or tasks.
The objective of SOP in Industry:
To lay down a procedure for the preparation, review, approval, distribution, control & revision of Standard Operating Procedure In the Pharma Industry.
Scope of SOP in Industry:
This procedure is applicable to all sops of the formulation plant of the Pharma Industry.
Responsibility of SOP in Industry:
Personnel (originating department) – Preparation of SOPs.
Department Head/nominee (originating department) – Checking of SOPs.
Head-QA– Approval of SOPs.
QA Personnel – for control, issuance, retrieval, and destruction of SOPs.
Accountability of SOP in Industry
Head – QA / Plant Head shall be accountable for compliance with SOPs.
The procedure of SOP in Industry:
The following procedure shall be used for the preparation of SOP.
All SOPs shall be written and prepared in the format given in Annexure -01.
All SOPs shall be written in the English language.
The language used in SOP shall be clear, instructive, sequential, and unambiguous.
Where required, SOP may be additionally prepared in vernacular language for easy understanding of the support functions. Contents of such SOP shall be verified and certified for accuracy by QA (Quality Assurance).
Classification of SOP in Industry:
All the SOPs shall be classified into 3 categories, viz.
General SOPs (GN) -which are applicable to all the departments/ areas in the plant.
Sub-general SOPs (SG) – which are applicable to more than one department /area.
Specific SOPs (SP) – which are applicable to specified departments/ areas.
SOP in Industry numbering procedure :
Each SOP shall be assigned a unique SOP number by the QA department.
All the SOPs shall be numbered in the following manner.
Each SOP shall be numbered as an alphanumerical number consisting of 13 characters. For example, SOP on the preparation of SOPs shall be numbered as
XX-YY-ZZZ-R01.
The first 2 characters “XX” represent the originating department.
The SOP numbering shall follow the below-mentioned guidelines for department prefixes:
Originating Department (Department/ Area Prefix)
- Quality Assurance (QA)
- Quality Control(QC)
- Production – Oral (Tablets, Capsules & Dry Syrup)(PO)
- Warehouse(WH)
- Engineering(ER)
- Personnel & Administration(PA)
- Regulatory Affairs(RA)
The 3rd character ‘-‘ is a dash.
The 4th and 5th characters “YY” represent the category of the SOP, for example, ‘GN’ shall mean General SOP.
The 6th character ‘-‘is a dash and the 7th, 8th, and 9th characters “ZZZ” denote the serial number of the SOP.
The 10th character ‘-‘ is again a dash and the 11th, 12th, and 13th (last 3) characters “R00” denote the revision number of the SOP.
For example, general SOP may be numbered as “QA-GN-001-R03”, where “QA” refers to the concerned department prefix, “GN” refers to the “general” category of SOP, “001” refers to the sequential number of the SOP and “R01” refers to the sequential revision/version number of the SOP.
For example, sub-general SOPs may be numbered as “QA-SG-001-R00”, where “QA” refers to the concerned department prefix, “SG” refers to the “sub-general” category of SOP, “001” refers to the sequential number of the SOP and “R00” refers to the sequential revision/version number of the SOP.
For example, specific SOPs may be numbered as “QA-SP-001-R00”, where “QA” refers to the concerned department prefix, “SP” refers to the “department-specific” category of SOP, “001” refers to the sequential number of the SOP and “R00” refers to the sequential revision/version number of the SOP.
Revision/version number – Each SOP shall have a revision/version number. If any SOP is prepared for the first time, its revision/version number shall start with ’R00’ and continue sequentially for later revisions/versions.
- All the points in the SOP shall be numbered sequentially. Similarly, the sub-paragraphs of each point shall also be numbered sequentially, with an incremental number derived from the Heading number. A military system of numbering shall be followed as under:
For example, if the Heading number is 1, the sub-headings shall have sequential numbers such as 1.1, 1.2, 1.3, and so on. Each step under the sub-heading 1.2 shall be numbered as 1.2.1, 1.2.2, and so on. In cases where the numbering of sub-paragraphs is not necessary, and listing is essential, bullets or other suitable identification marks may be used to illustrate the same.
SILDENAFIL CITRATE TABLETS
Creation of SOP in Industry
The following guidelines may be used for drafting an SOP.
An SOP shall be neatly typed using a computer (Microsoft Word) and printed in black ink on A4-size white paper (on one side of the paper only).
The font type and font size of the printed letters, including the Header and footer, shall be uniform (Arial 11), except for where bold text is required in the case of header, headings & notes.
For an SOP typing, the following page setup/word formatting details may be used preferably:
Top / Bottom / Left Margins = 1 inch
Right Margin = 0.7 inch
Gutter (from the edge) Header / Footer = 0.8/1.0 inch
Page Border (from Text) = top 4 points/bottom 0 points
Page Border (from Text) = left / right 12 points
Numbering Indent = 0 inch
Hanging Indent / left tab = 0.75 inch
Line spacing = single, Heading / Subheading = Bold letters
Paragraph spacing (before & after) = 6 points
Each page of the standard operating procedure consists of the header at the top and details as mentioned below:
- All characters of the header are to be mentioned in bold fonts
- The header consists of 8 rows. Rows no 1, 2, 3, 7, and 8 consist of no columns where as rows no. 4, 5, and 6 consist of 2 columns.
- In the first row, the name of the company should be written.
- In the second row, the subject of the document i.e. Standard Operating Procedure (SOP) should be written.
- In the third row, the title of the Corresponding SOP is to be mentioned.
- In the first column of the fourth row mention SOP No.
- In the second column of the fourth row write the page number: The “page numbering” for the SOP shall be done in the format “Page x of y” at the designated place in the Header. Only the SOP shall be given page numbers in a sequential manner, however, the annexure/format to the SOP shall be page numbered individually.
- In the first and second columns of the fifth row, mention the effective date and review date respectively.
- In the first and second columns of the sixth row, mention the previous and new versions.
- In the seventh row, mention originating dept. from which the SOP has originated/initiated.
- In the last/final row, the distribution list has to be mentioned i.e. the name of the depts. (departments) to which the SOP has to be distributed.
Each page of the standard operating procedure consists of a footer at the bottom of the page and details as mentioned below:
All the characters of the footer are to be mentioned in Arial 11 font.
The footer consists of a table of three columns and three rows on the first page and on the remaining pages three columns and two rows.
The first row of each column consists of Prepared By/ Date, Checked By/ Date, and Approved By/ Date respectively on each page.
The person initiating/ preparing, checking/ reviewing, and approving the SOP should sign with the date in the second row of each page and write the full name in the third row of the first page only in every SOP.
A person directly supervising the operation shall initiate the creation/revision of an SOP.
An SOP shall be written after thorough understanding of the operating procedures. The author of the SOP shall have adequate knowledge, training and experience in the related areas of operations.
An SOP shall be easy to understand / follow and shall depict the sequence of activities logically.
Wherever necessary, some illustrations, drawings or exhibits may be incorporated in the SOP, to provide better clarity and understanding.
Wherever abbreviations are used, these shall be elaborated at the first use itself and a summary may be given at the end of the SOP.
Effective / Review date:
An “Effective Date” in DD-MM-YYYY format (e.g. 01-09-2020 for 1st September 2020) shall be assigned to each SOP, after taking into consideration the necessary training period and creating awareness to all concerned prior to the effective date.
A “Review date” in DD-MM-YYYY format (e.g. 01-03-2023 for 1st March 2023) shall be assigned to each Standard Operating Procedure.
The review date for an SOP shall be not more than “Two Years”, from the Effective date.
If there is no change in SOP, during the periodic review, it shall be reprinted incorporating the revised effective date/review date, revision number, and the reason for review as ‘Periodic Review’.
The review shall be completed within 30 days from the “Review Date”.
Body of SOP: Following details shall form the body of SOP.
The “Objective” shall describe the title & intent of the SOP. An overview of the intent of the SOP shall be briefly mentioned here. The objective of each standard operating procedure is to be started with “To lay down procedure or To establish a procedure or To provide a procedure”. The objective of the respective standard operating procedure is to be related to the title of the same.
The “Scope” of SOP shall describe the areas/personnel/equipment/process, to which this SOP is applicable. If there are any specific areas for which the SOP is not applicable, the same may also be mentioned.
The ‘Responsibility’ shall define the person in charge of initiating/executing the activity.
The “Accountability’ indicates the designation of individuals accountable for the compliance of the system or procedure defined in the SOP.
The “Procedure” shall describe the activities to be carried out as a part of SOP.
A “flow chart”, detailing the steps involved, may be attached to the SOP.
A suitable “Record format” shall be prepared for recording the control parameters and included as a part of the SOP itself. A unique format number shall be assigned to this format.
A list of annexure(s), described in the SOP, shall be mentioned (along with the annexure number, title, format number, and the total number of pages of the annexure) in section 6.0.
References to the current editions of books, operation manual, guidelines, and statutory, & regulatory requirements / SOPs may be made (wherever applicable) in the references section 7.0.
“Reason of Revision” indicates the details of the revision that occurred in the same standard operating procedure. If the SOP is not revised/ new, mention not applicable due to the first version. Each SOP consists of a history chart, in which the date of revision and detail of revision or nature of change has to be mentioned.
A list of standard Abbreviation(s) / Acronyms (s) used in the SOP may be mentioned, at the end of the SOP.
At the end of the SOP, the initiator has to write “END OF SOP” in capital and bold letters.
Annexure Numbering System In Pharma Industry:
Each Annexure shall be numbered as an alphanumerical number consisting of 11 characters. For example, Annexure for “Quality Assurance ‘general’ SOP” shall be numbered as “QAGN001/A01”.
In the Annexure number “QAGN001/A01”, the first 7 alphanumerical characters (viz. QAGN001) represent the SOP Number, to which the annexure belongs.
The 8th character ‘/’ is a forward slash as a separator.
The 9th character ‘A’ denotes ‘Annexure’.
The last two characters ‘01’ denote the serial number of the annexure, of that particular SOP.
Format Numbering system In Pharma Industry:
Each ‘record format’ given in an annexure (to be used for data recording), shall have a unique format number for control. Annexure meant for reference purposes only, shall not have a format number (for example a flow chart).
Each “record/documentation format” shall be numbered as an alphanumerical number consisting of 14 characters. For example, the first data recording format of SOP QA-GN-001 shall be numbered as QAGN001/F01-00.
In the format number “QAGN001/F01-00”, the first 7 alphanumerical characters (viz. QAGN001) represent the SOP Number, to which the format belongs.
The 8th character ‘/’ is a forward slash as a separator.
The 9th character ‘F’ denotes ‘Format’.
The next two numerical characters ‘01’ denote the serial number of the format, of that particular SOP.
The 12th character ‘-’ is a dash.
The last two characters denote the ‘revision/version number’ of the format or SOP, starting with ‘00’ and continuing serially in increments of one unit.
Revision of SOP In the Pharma Industry:
An SOP shall be revised, if required by the originating department.
The person, initiating a revision, may request an uncontrolled copy of the SOP. Handwritten comments may be made & forwarded to the department head & for further review.
Alternatively, a fresh draft of the SOP may be prepared as per the guidelines given in this SOP and forwarded to department head & QA.
For updating / revising an SOP, the following “SOP change control Procedure” shall be used.
The initiation of changes in an SOP shall be made as per “SOP change control form”.
Draft of the revised SOP shall be attached, along with the “SOP change control form” and forwarded to department head / QA for review.
The department head shall review the changes proposed to ensure compliance and forward it to QA for approval.
QA shall review the SOP / changes for compliance to cGMP (Current Good manufacturing practices) / regulatory requirements, and approve the same.
A logbook shall be maintained for recording all the ‘SOP change control form numbers’ assigned and the relevant details).
END OF SOP
