SOP of SOP

1. OBJECTIVE

The objective of this Standard Operating Procedure (SOP) is to describe the procedure for preparation of SOPs, review, approval and to ensure that uniform format of SOP is used within the XXXXX

1. SCOPE

This SOP is applicable for the SOPs related to the various functions, departments covering cGMP requirement within the scope of XXXXX

1. RESPONSIBILITY
   1. Define User Department responsibility.
   2. Define Head of the user department responsibility.
   3. Define Head QA or designee responsibility.
2. PROCEDURE
   1. Preparation, Review and Approval of SOP
      1. The contents should be clear, specific, simple and user friendly.
      2. Each page of SOP shall be divided into three parts: Header, Contents and Footer.
      3. SOP header shall be filled in the following manner.

          STANDARD OPERATING PROCEDURE

1. Whenever new SOP is prepared, sequential SOP number shall be allotted.
2.  
3. SOP footer shall be filled in the following manner.

1. Guidelines described below shall be followed to write the SOP (body of the SOP).
   1. OBJECTIVE

An overview of the intent of the SOP shall be briefly mentioned. This includes ‘why the procedure is written’ and ‘why it is being performed’.

1. SCOPE

Define to which Department / Area / equipment / procedure the SOP is applicable. This includes ‘when this procedure needs to be performed’ and ‘where this procedure applies’.

1. RESPONSIBILITY

The personnel responsible to perform the procedure and the personnel responsible to see it is performed correctly shall be mentioned under this heading.

1. PROCEDURE
   1. The operating procedure shall be explained in short, with clear sentences and shall be easy to understand.
   2. Wherever required the SOP’s can be written in local language or with pictorial representation or flow chart shall be included for better understanding.
   3. It shall mention all checks to perform, records to be   maintained, and frequency of various checks / operations etc., and special precautions, if any.
   4. There should be specific instructions for each step in sequential order including the preparatory work, which must be done before starting the main procedure, as well as instructions for recording and reporting the results.
   5. Clear concise, step by step instructions on how to perform the procedure, easy to read format. This should be written as instructions for the operator to follow, without a lot of theoretical background. A section on fundamental principles can be included if necessary.
   6. The information presented should be unambiguous and not overly complicated.
   7. The procedure should be given in stepwise/sequential fashion with each step being identified by a number indicating the subgroups.
   8. The subheadings are numbered sequentially in bold letters and giving the main point number and sub point number sequentially does subsequent numbering.
   9. Include the details of all operations, operational conditions, preliminary steps and precautions to be taken before beginning the procedure, if any.
   10. Make cross-reference to other documents where this is relevant, e.g. logbooks or other SOPs under heading ‘reference.’
   11. Explain what to do if there are problems during the procedure/test. Indicate where the results should be recorded.
2. DEFINITIONS AND ABBREVIATIONS

Definitions and Abbreviations shall be given in this section for better clarity and understanding according to procedure.

1. ANNEXURES/FORMATS:
   1. Under this section all Annexures/Formats designed to full fill the procedure shall be addressed.
   2. Preparation of Annexures/Formats:
      1. Wherever applicable Annexure/Formats shall be prepared by the user department as per the work/activity requirement.
      2. Pepare the Format/Annexure as per the requirment.
      3. Format/Annexure shall be prepared, reviewed and approved by the same persons along with the respective SOP. In case of revision, signatory personnel may change.
      4. Define SOP Format  number
      5. Whenever require a change in format, format can be revised through change control, in case of SOP supporting even proposed format change too.
2. REFERENCES
   1. The document that has been referred for documenting the SOP e.g. various Pharmacopoeias, GMP guidelines, International standards and other SOPs etc. shall be indicated by giving the title and document number of the procedure.
   2. All the documents, which are given in this section need not to be attached to this document, they might be reference purpose.
   3. If there are no references then mention NA (Not Applicable).

1. DISTRIBUTION

Distribution of the SOP shall be done to the concerned department. Relevant SOP should be issued to relevant department. Copies of the SOP shall be distributed according to the SOP ‘Document control’, SOP/QA/XXX.

1. END OF DOCUMENT

All the SOP’s shall be ended with “END OF DOCUMENT” typed in bold capital letters after the last sentence of the SOP in the last page at the centre.

1. HISTORY OF CHANGES:
   1. The history of changes shall be recorded in brief and chronological order in the designated format and shall be attached to the SOP as annexure.
   2. The history of changes shall be recorded in brief and chronological order in the designated format and shall be attached to the SOP as annexure.
   3. Consider change history is as separate entity of SOP and page number shall be numbered separately. Format for history of changes as follows;

1. The initiator shall take a draft copy of the SOP prepared based on the above Guidelines and shall submit to HOD or second competent person for review and same shall be forwarded to Quality Assurance for further review against GMP compliance.
2. After receiving the comments from all, final copy shall be printed by initiator after addressing the comments in the procedure.
3. Final copy of SOP shall be signed by initiator and Head-initiating department and same shall be forwarded to the SOP approver.
4. Effective date shall be written by Quality Assurance personnel in consultation with initiating department. The maximum allowable window period between the approval and effective date is 15days.
5. Next review date: All SOPs shall be reviewed once in every 2 years from the effective date of SOP or as and when required. Allowed window period for SOP review is ±1 month on the review date. This next review date will be written in standard date format DD.MM.YY in blue ink ball pen. 
6. Controlled copy SOPs shall be distributed by the Quality Assurance department as per the Document control SOP (SOP/QA/xxx) to the departments specified in distribution section.

1. DEFINATIONS AND ABBREVIATIONS
   1. Standard Operating Procedure: Detailed, written instructions to achieve uniformity of the performance of a specific process or activity.
   2. Annexure: Annexure is the prescribed informative data / illustration specific to the SOP. E.g.: Flow charts, case examples etc.
   3. Format: Forms/records are the provisions to record the observations / data generated during the performance of activity according to procedure.
   4. Template: Template is the model/specimen format, which guide to prepare subsequent documents/formats by considering the same pre-defined structure.
   5. SOP     : Standard Operating Procedure
   6. QA      : Quality Assurance
   7. GMP   : Good Manufacturing Practice
2. ANNEXURES/FORMATS
   1. Annexure-1     : History of changes
   2. Annexure-2     : Template for SOP
   3. Annexure-3     : Template for Annexure/Format
   4. Annexure-4     : Departmental codes and functional subgroups

1. REFERENCES:
   1. SOP for document control (SOP/QA/xxx)
   2. SOP for change control (SOP/QA/xxx)
   3. Part 1: Standard operating procedures and master formulae of WHO guide to good manufacturing practice (GMP) requirements.
2. DISTRIBUTION
   1. Quality Assurance department
   2. Quality Control department
   3. Production department
   4. Engineering department
   5. Warehouse department
   6. HR and Administration department
   7. Safety department
   8. Research and Development department
   9. Purchase department

END OF DOCUMENT

Standard operating procedure, quality assurance, gmp requirement