SOP PREPARATION AND FORMAT DESIGNING

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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