- To lay down the procedure for the preparation, approval, review and control of Standard Operating Procedures.
- All the personnel of all department to be familiar with this Standard Operating Procedure (SOP).
- The approving authorities to ensure compliance to the preparation, approval and
- Review procedure.
- Head – QA or his designee to ensure controlled distribution of SOPs.
- All the official SOPs are to be generated by computer on the format known as “Standard Operating Procedure” (Refer annexure -1). Guidelines for filling the format are described below:
- SOP No.:
- This is a unique number given to each SOP. This number consists of eight characters as described below:
- The first two characters are letters denoting the department code.
- The next three characters are serial number starting from 001 in thesequential order within the department.
- The sixth character is “-” Dash.
- The last two characters denote 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.
- Example : The first SOP prepared for Quality Assurance Department shall be numbered as “QA001-00” and the same when revised for first time shall be numbered as “QA001-01”.
- Page No. :
- Give the specific page number as well as the total pages comprising the Standard Operating Procedure. Example : 1 of 5.
- Department :
- Give the name of the Department to which the SOP pertains.
- Example : Quality Assurance.
- Title :
- Give the detailed heading of the SOP.
- Effective Date :
- The effective date is the date when the contents of SOP become operative, after training of the concerned personnel on the SOP.
- Initiated by :
- The person who prepares the SOP, shall sign with date in this column. The operating personnel of the respective department shall prepare the SOP.
- Approved by :
- Each SOP shall be approved by two functional heads :
- a) Head of the Operating Department.
- b) Head of Quality Assurance.
- The approving authority shall ensure that the SOP is validated/operational suitability of the SOP is verified.
- Authorised by :
- Every SOP shall be authorised by the Plant Head or his designee.
- The SOP shall have the following headings :
- Objective 2. Responsibility 3. Procedure 4. Documentation
- Objective :
- An overview of the intent of the SOP shall be briefly mentioned here.
- Responsibility :
- Shall specify the personnel responsible to ensure implementation and compliance.
- Procedure :
- Shall describe the detailed operating procedure in simple and clear sentences. It shall include the details of all operations, operational conditions and precautions to be taken, if any.
- Documentation :
- Shall include appropriate formats, specimen labels etc., needed to record the compliance of the SOP.
- Each format shall be given a number. The number consists of 12 characters.
- The first two letters denote department code
- The next three characters denote serial number of the SOP.
- The sixth character is “-” dash.
- The seventh character is ‘F’ denotes “Format”.
- The eighth and ninth characters denote the serial number of the Format of that particular SOP. The tenth character is “-” dash.
- The last two characters denote revision number of the respective format.
- Format No. shall appear on left bottom of the format.
- A specimen of each format shall be enclosed with respective SOP and stamped as “Specimen” and signed with date by the Head of Quality Assurance or his designee.
- Submission of New SOP :
- 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 for approval.
- Once approved by the Department Head, the same shall be routed for approval to the Head of Quality Assurance and the Divisional Head.
- A disagreement on any aspect of the SOP from any one of the approvers shall stop any ‘New SOP submission’ until all approvers come to an agreement on the proposed new SOP.
- The Original copy of the SOP shall be initiated, approved and authorised with signature and date. The effective date shall be entered after training the concerned personnel on the new SOP.
- Review procedure of SOP :
- Every SOP shall be reviewed once in every two years by the concerned personnel and the Head of the Department.
- During review or otherwise any changes desired and deemed necessary shall be initiated through a ‘Change Request Notice’ as per SOP on ‘Change Control Programme’.
- Whenever SOP is reviewed, the changes made shall be entered on the ‘Change History’ and attached at the end of the SOP.
- The reviewed and approved SOP shall be effective after training of concerned personnel.
- In case there are no changes required in the existing SOP during review, the same shall be mentioned in the Change History as ‘No changes required, Reviewed due to mandatory requirements’ and the same SOP shall be valid for the next two years with no change in the revision number or effective date.
- Distribution and Control of SOP :
- The original copy of the SOP shall have the original signatures and shall be maintained at Documentation cell. Issue of the SOP shall be controlled by QA department. The details of issuance shall be entered in “Issue Record”.
- Officer – Documentation shall provide the photocopy of the SOPs from the original copy to the concerned department(s).
- Officer – Documentation shall stamp “Issued by : ____________”
- ”Issued to : ____________”
- “User Copy No.: ____________” on the top of the SOP, sign with date and issue the copy to the concerned
- If need arises for an additional copy of SOP, the concerned Head of the Department shall make request to Head of Quality Assurance Department.
- Head – QA shall arrange for the issue of a copy of the requested SOP.
- The details of issuance shall be recorded in Issue record
- Photocopying of any SOP is prohibited, unless written permission is obtained from the Head of Quality Assurance Department.
- Any SOP issued for non-operational use shall be stamped as ‘Uncontrolled Copy, Not for Operational Use’ on every page, with signature of Head of Quality Assurance Department or his designee.
- User copies of old and superseded SOPs shall be returned to QA department.
- QA- Head shall ensure reconciliation and destruction. The destruction details shall be entered in “Issue Record” . The Original copy shall be stamped as “Obsolete – For reference only” and stored.
|List of Department Codes|
|Quality Assurance||– QA|
|Quality Control||– QC|
|Research & Development||– RD|
|Analytical Development||– AD|
|Regulatory Affairs||– RA|
|Pilot Production||– PP|
|Production Planning||– PL|
|Information Technology||– IT|
|Novel Drug Delivery Research||-NR|
|Audit & Compliance||-CA|
- Forms and Records (Annexures)
- Not Applicable
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
Date Revision Number Reason for Revision – 00 New SOP