ABOUT AUTHOR:
MR. Gunjegaonkar S.M.
Assistance Professor.
Dept. of Pharmacology JSPM’s Charak College of Pharmacy and Research, Wagholi, Pune, Maharashtra.
gunjeshiv@gmail.com
INTRODUCTION:
Standard operating procedures are integral part of all the pharmaceutical companies. To obtain the standard quality product intended for human and animal use, manufactured product must have gone through CGMP rules and regulations. Standard operating procedure is an also part of CGMP and GDP (Good documentation practices). Any process, procedure, activity being carried out at any time, at any step that has to perform according to SOP. Standard operating procedure must be written by a subject expert considering the GMP, working feasibility, accountability and authorized by authorized persons. In the face of a challenging regulatory environment, some leading Pharmaceutical companies have found ways to improve quality and costs significantly. To drive this kind of beneficial change, companies must first create a culture where quality objectives are transparent, well understood, and undoubtedly these goals can be achieved by following certain sets of procedures called as “Standard Operating Procedures” (SOP). Procedures are essential for any plant’s effectiveness and efficiency, and they are regulatory requirement in the Pharmaceutical Industry. A typical Pharmaceutical Industry has an average of 1200- 1300 SOPs. A Parenteral Drug Association (PDA) survey found that a typical pharmaceutical company must manage an average of 1250 CGMP-required SOPs and that the average maintenance burden is 15,000 h per firm.
REFERENCE ID: PHARMATUTOR-ART-1825
A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization. The development and use of SOPs are an integral part of a successful quality system. It provides information to perform a job properly, and consistently in order to achieve pre-determined specification and quality end-result.
In designing of SOP Following points are considered
OBJECTIVE:
To lay down procedure for the preparation of Standard Operating Procedures.
SCOPE:
This procedure is applicable to all the SOP’s throughout the organization.
RESPONSIBILITY:
Person Performing: Respective HOD’s of concerning departments
Person Monitoring: QA officer/ HOD QA
PROCEDURE:
All SOP’s shall be computer typed using Times New Roman font.
Format of SOP shall be as per Annexure SOP/QA/002/1. Each SOP has:
I) Header,
II) Signature block and
III) Body.
Header: Present on all the pages of SOP and includes
Company Logo, Name, address & Concerned Dept.: Company Logo, CHARAK Pharma Limited, Wagholi-Pune & Name of Concerned Department. (In capital bold letters of font size 16)
Document Type: Standard Operating Procedure (In capital bold letters of font size 14)
Ref. No.:It is like SOP/DC/YYY-Z Where DC depicts the department code as below:
PE: Personnel Department
PD: Production Department
MT: Maintenance Department
QA: Quality Assurance Department
QC: Quality Control Department
ST: Store Department
PU: Purchase Department
YYY is the sequential number starting from 001 for each department.
And Z is the revision status, starting from 0 for the original version and 1 for the next version and so on. (In capital letters of font size 12).
Supersedes: It is the Ref. No. of the earlier version. (In capital letters of font size 12).
Effective Date: It is the date from which the SOP shall be put in use. The date format has to be DD/MM/YYYY, where DD indicates the date, MM indicates the month & YYYY indicates the year (e.g. 01/11/2007). Date shall be written with blue indelible ink pen.
Review Date: It is the Month & Year during which the SOP shall be revised e.g. 21/2013, written with blue indelible ink pen. It shall be maximum 2 years from the effective date.
Page No.: It is like X OF Y. Where X is the individual page number and Y is the total number of pages. (In capital letters of font size 12)
Title: It shall be clear and descriptive. (In bold capital letters of font size 12).
Signature Block:It shall be below the header and only on the first page of the SOP.
(Titles in the rows & columns shall be in bold letters & other text in normal letters of font size 12. Name and designation shall be typed. And signature and date shall be put in blue indelible ink pen)
Prepared by: Signature with date, name and designation of the person from user department who has drafted the SOP.
Verified by: Signature with date, name and designation of the HOD or the person from user department who has verified the draft of the SOP.
Authorized by:Signature with date, name and designation of the person authorizing SOP, DGM QA or HOD QA.
e. Body: It shall contain the subject matter, which is written in the following Manner.
(Subtitles in capital bold letters and text matter in normal letters of font size 12).
OBJECTIVE: It shall define the purpose of the SOP.
SCOPE: It shall define the area of application.
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RESPONSIBILITY: It shall specify the person responsible for carrying out and monitoring the activity as per the SOP.
PROCEDURE: It shall give all steps required by the process in a proper sequence and instructions to be followed while carrying out the activity so as to achieve the desired goals.
Procedure shall be:
a) Logically lay out.
b) Written in the imperative (authoritative) tense.
c) User friendly.
d) Simple to understand and in plain unambiguous English.
e) To the point with no unnecessary information.
f) In standardized terminology.
ABBREVIATION:This shall include list of abbreviations used and their meaning.
ANNEXURE:This shall include list of annexure attached.
REFERENCE:This shall include list of reference documents.
ABBREVIATION:
HOD : Head of the Department
SOP : Standard Operating Procedure.
QA : Quality Assurance
DGM : Deputy General Manager
ANNEXURE:
Annexure – SOP/QA/002/1 - ‘Standard Operating Procedure’ Form.
REFERENCE:
SOP issuance logbook
Standard SOP format.
GENERAL NOTES FOR SOP DRAFTING
1. All SOPs should be made in Approved format only.
2. There shall be written down procedure SOP for each activity.
3. The need of SOP’s for various equipment / operation shall be consultation with Department Head along with actual user.
4. SOPs for machine operation shall be prepared by in consultation with engineering department and user department.
5. SOPs for validation, stability study and calibration shall be prepared in consultation with Quality Assurance.
6. SOPs shall be prepared in language that is easy to understand.
7. The writing of procedure in an SOP is based on the category of SOP. Specialized SOPs: Standard Operating Procedure of this category includes following points:
General conditions or prerequisites
8. Control of Soft Copy of SOP
- Soft copies of SOP control though Password Protection on Compact Disk with Corporate QA only. The access shall be restricted to QA Officer or Authorized personnel of QA.
Soft copy will be stored in separate folder as :
Main Folder as SOP
Sub Folder as Department code e.g. MN, ST, QA, QC etc.
Files as ANK/PRSOP/001,ANK/PR SOP/002, ….etc. for each department.
9. Control of Master Copy of SOP:
- Hard copy of SOPs shall be stored in QA department. The hard Master Copy will bear original signature and red stamped of “MASTER COPY” at bottom right side corner of the each page.
10. Control of Controlled Copy of SOP:
- Controlled copy is a photocopy of Master Copy and is under the control of QA for issue to user department which is stamped as “CONTROLLED COPY” at blue space at bottom side of each page in blue ink. Copying of this copy is strictly prohibited. The stamp shall be applied in blue ink on each page and shall bear the original signature and date issue of QA personnel with black ink.
11. Issuance of SOP:
- Controlled copy of SOP shall be issued to the user department, each SOPs issued and entry is recorded in SOP issue register.
- Recall of SOP:SOP can be recalled in following condition:
- SOP is not displayable /distorted
- SOP is not legible
- For review
- Record of recall shall be maintained.
Review of SOP: SOP shall be reviewed after every 2 years from the date of preparation or when any change to be made in the procedure, format etc. through change control system. Only two reviews can be done and same will be re-printed, if there is no change in the content of SOP.
12. Destruction of SOP:
- Master copy of obsolete SOP shall be stamped as OBSOLETE in Red Ink and preserved for one year from the date of absolution. The destruction shall be carried out by QA personnel and recorded with date of destruction. Obsolete controlled copy will be recalled and destroyed by shredding.
13. Copies to Distribution Sites:
- Quality Assurance
- Quality Control
- Production
- Engineering
- Stores
- Personnel & Administration
14. Review History:
References:
1. pharmainfo.net.
2. pharmaguideline.com
3. Pharmaceutical Quality Assurance, M.A. Potdar, Nirali Prakashan, Pune.
4. Current Good Manufacturing Practices, M.A. Potdar, Pharma-Med Press, Hyderabad.
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