SOP On SOP – Initiation of new SOP In the Pharma Industry
The initiator of SOP shall prepare the SOP draft.
The SOP initiator shall record the relevant details in the “New SOP Initiation Form (SIF)”, attach the SOP draft along with this form and forward it to the concerned department head / QA for review.
The completeness of the draft SOP shall be checked by the concerned departmental head / in-charge, for accuracy of subject matter as well as logical arrangement of data & text.
After review, the SOP shall be signed (with full signature) & dated, using a blue ink ballpoint pen, in the ‘Prepared By’ & ‘Checked By’ columns, along with the name written (handwritten) on the first page only. The signed SOP copy shall be forwarded to QA for approval.
The SOP shall be reviewed by QA for its compliance with cGMP and regulatory requirements.
Officer QA or above shall assign the SIF number as ‘SIF/10/001’ to the “New SOP Initiation Form (SIF)”, where SIF denotes ‘SOP Initiation Form’, ‘10’ represents the year and ‘001’ denotes the sequential serial number of SOP initiation forms.
Finally, the SOP shall be signed & approved by Head-QA / QA nominee, with the name written (handwritten) on the first page only.
All the pages of SOP including the annexure shall be signed and dated only in blue ink, using a ballpoint pen.
QA shall maintain a logbook for the approved “SOP Initiation Forms”.
Storage In Pharma Industry:
A hard copy and soft copy (electronic copy) of the approved SOP shall be forwarded to the QA department.
QA shall delete the previous electronic version and store the current version in Computer, for the purpose of viewing only.
The electronic file shall be named as per the SOP number.
The “History Sheet” of each SOP shall be updated by the respective department and maintained by QA along with the current version of that SOP.
The “History sheet” of an SOP shall be maintained till the SOP is in use. If the History sheet is completely filled, a new sheet shall be appended along with the filled History sheet.
Training In Pharma Industry:
For a newly created/revised SOP, training shall be given to all concerned, if required, depending on the nature of changes and SOP parts relevant to their function.
The training shall be imparted before the effective date and the relevant training records shall be updated in “Training Record” as per SOP on training. The Sectional Head / Departmental Head shall ensure that training is imparted to all concerned.
Master List of SOPs:
QA shall maintain a master list of SOP. It shall contain the list of SOPs of all the departments along with details of their distribution.
The list shall be revised quarterly. The list shall be converted into a protected PDF format with a print option.
A hard copy shall be printed and signed by Head-QA / QA nominee and kept in QA records as the master copy. To the rest of the departments, only a controlled copy of the master list shall be distributed for use.
A respective departmental head shall be responsible for maintaining the current version of the master list by updating the controlled copy issued.
If any change takes place in the master list in between a quarterly Updation, manual corrections shall be allowed with the initials of the sectional/departmental head and shall be communicated to QA. Such changes shall be incorporated into the master list during the next quarterly revision by QA.
Master Copy of SOP In the Pharma Industry:
The originally signed copy of an SOP shall be referred to as the “Master Copy”. This copy shall be stamped as “Master Copy” in ‘Red ink’, on the front side (at the top right corner), and signed & dated.
The master copies of all SOPs shall be maintained & controlled by QA only.
Master copies of all SOP shall be filed department-wise, in an orderly manner, along with a proper index.
Distribution / Issuance of Controlled Copies of SOPs In the Pharma Industry:
All the photocopies of the “Master Copy” shall be stamped as “Controlled Copy” and “Copy No.” in Green ink (on the bottom of each page) and signed & dated, without obscuring any text.
Each Controlled copy shall be numbered as per the Controlled Copy number for a section/area, which shall be assigned as follows:
If the concerned department is assigned “Controlled Copy No. 4” as a distribution copy and requires two copies in the same department, then the controlled copy numbers shall be assigned as ‘4/1’ and ‘4/2’.
These controlled copies shall be issued by QA, to various departments as per the “distribution list”.
The “distribution list” shall be developed by QA, in consultation with SOP originating This distribution list may also be reviewed/revised, during the revision of the SOP.
The department head, for the SOP originating department, shall also communicate the exact number of copies required for his area.
As per the distribution list, QA shall make the required number of photocopies from the Master Copy.
The SOP receiving department may send a request for additional copies to QA, duly approved by the department head. This request may be sent through the prescribed SOP requisition form.
After providing a requisite number of copies, QA shall update the distribution record.
The SOP shall be handed over to the area supervisor and acknowledgment shall be taken on Distribution List Log Book.
QA shall perform reconciliation of distribution & retrieval of an obsolete version of SOPs, for destruction.
QA shall destroy these retrieved obsolete copies and record them in the Distribution List Log Book.
SOPs received from external locations/customers shall be distributed as ‘uncontrolled copies’ only. The concerned department may use these copies as guidelines and review the existing SOP for necessary amendments. SOPs of external origin are for reference only.
Deletion of SOP In the Pharma Industry:
In case of discontinuation of an existing operating procedure, the existing SOP may be discontinued/deleted. However, the same SOP number shall not be allotted to any newly created SOP.
The deletion of SOP shall be initiated by originating department, as per the prescribed.
Head-QA shall assess the impact, of the deletion of that SOP, on the GMP system and accordingly authorize the deletion.
QA shall record the retrieval/deletion record/ data of SOP as per the prescribed format and accordingly master list of SOPs shall be updated.
A master copy of deleted SOP along with the “history sheet” & shall be archived and the electronic copy of the SOP shall be deleted from the storage system.
Copies to Regulatory Agencies / Customer copies In Pharma Industry:
If any Regulatory agency / Customer requires a copy of the SOP / Document for reference, the copy shall be provided by QA only.
This copy shall be stamped as “Uncontrolled Copy” in Blue ink and signed & dated on all the pages, before issuance.
Archival of SOP In the Pharma Industry:
After revision of an SOP, all the pages of the “previous Master Copy” shall be stamped as “Obsolete Copy” in red ink, on the center of each page. These obsolete master copies shall be archived in QA records. Obsolete SOPs shall be deleted from the computer system by QA.
Soft Copies (electronic copies) of the current version of SOPs shall be available with QA and backup of electronic copies of SOPs shall be taken on a monthly basis in CD/ DVD by QA.
Obsolete Master copies of SOPs shall be filed separately by the QA documentation cell and the log shall be maintained
Such obsolete copies shall be maintained for 10 years (from the effective date). After completion of the retention period, these shall be destroyed by QA and the record of destruction shall be maintained.
List of Annexures / Formats:
References (if any):
Reason for Revision:
- SOP: Standard operating procedure
- QA: Quality Assurance
- SCCF: SOP Change Control Form
- cGMP: Current Good Manufacturing Practices
- cGLP: current Good Laboratory Practices
- QC: Quality Control
- SIF: SOP imitation Form
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